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Kim Lee, acting senior quality assurance lead

Description: NIHR Southampton Clinical Research Facility Auto Generated Title Kim develops, implements and maintains systems that assure the quality of cl inical research at Southampton ’ s clinical research facilities. Kim is responsible for implementing and overseeing quality assurance (QA) procedures for studies conducted in the facility, ensuring compliance to GCP and overseeing work towards accreditation. She is leading the CRF through the MHRA phase I re-accreditation process. Working closely with the Early Phase Safety Committee, she is ensuring phase I study Risk Assessment is approved in a timely manner. Kim j oined in 2012 as a receptionist and developed into the role of acting senior QA lead.
Url: /ClinicalResearchinSouthampton/Our-people/Clinical-research-facility-people/Kim-Lee-acting-senior-quality-assurance-lead.aspx

ObinutuzumabVenetoclax LowRisk

Description: Chemotherapy Protocol Chronic Lymphocytic Leukaemia Obinutuzumab-Venetoclax (Low Risk) Regimen • CLL – Obinutuzumab-Venetoclax (Low Risk) Indication • Chronic lymphatic leukaemia (CLL) or small lymphocytic lymphoma (SLL) in adult patients where; - there is 17p deletion or TP53 mutation - there is no 17p deletion or TP53 mutation and for whom cyclophosphamide, fludarabine, and rituximab or bendamustine and rituximab are unsuitable - there is no 17p deletion or TP53 mutation for whom cyclophosphamide, fludarabine, and rituximab or bendamustine and rituximab are suitable and all the criteria as described in the appropriate Bluteq form are met and an application for use has been approved. Toxicity Drug Obinutuzumab Venetoclax Adverse Effect Infusion related reactions, progressive multifocal leukoencephalopathy (PML), cardiac toxicity, thrombocytopenia, neutropenia, tumour lysis syndrome Upper respiratory tract infection, neutropenia, anaemia, hyperphosphataemia, electrolyte disturbances, tumour lysis syndrome (TLS), gastrointestinal disturbance, raised blood creatinine, fatigue. The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring (Treatment only) • Hepatitis B status prior to starting treatment. Patients with positive hepatitis B serology should consult a liver disease expert before the start of treatment and should be monitored and managed following local medical standards to prevent hepatitis re-activation. Viral screening is also required before starting treatment for hepatitis C and HIV status. • Tumour burden assessment, including radiographic evaluation (e.g., CT scan) must be performed for all patients prior to starting therapy. • Assess risk for tumour lysis syndrome (TLS) including uric acid and bone profile prior to cycle one in those considered at risk of tumour lysis syndrome (please refer to table one for description of high, low and moderate risk TLS). • When starting venetoclax FBC, U&Es and LFTs (to include phosphate, calcium and LDH) on cycle one days 1, 2, 8, 9, 15, 16, 22, 23, 29 and 30 of venetoclax Version 1 (May 2021) Page 1 of 18 CLL-Obinutuzumab-Venetoclax (Low Risk) administration (not cycle days) • These parameters must be checked prior to any venetoclax dose increase. Consider on day 1 of subsequent cycles or refer to local guidelines. • FBC, U&Es (including potassium, phosphate, LDH, adjusted calcium and uric acid) and LFTs should be measured prior to starting therapy and pre-existing electrolyte abnormalities corrected. For patients at risk of tumour lysis syndrome (TLS), potassium, uric acid, phosphate, adjusted calcium, LDH and creatinine should be monitored at 6 to 8 hours and at 24 hours after the first dose and during each dose increase of venetoclax. Electrolyte abnormalities should be corrected promptly. The next venetoclax dose should not be administered until the 24-hour blood chemistry results have been evaluated (see section on TLS below). Consider admitting the patient for monitoring for TLS monitoring and treatment. During the ramp-up phase, the FBC counts needs to be considered prior to next dose escalation, while FBC counts at 6 to 8 hours and at 24 hours after the first dose and during each dose increase of venetoclax are not to be considered for TLS risk or dose modification. Dose Modifications The dose modifications listed are for haematological, liver and renal function and drug specific toxicities only. Dose adjustments may be necessary for other toxicities as well. Please discuss all dose reductions / delays with the relevant consultant before prescribing, if appropriate. The approach may be different depending on the clinical circumstances. Haematological Dose modifications for haematological toxicity in the table below are for general guidance only. Always refer to the responsible consultant as any dose reductions or delays will be dependent on clinical circumstances and treatment intent. Consider blood transfusion or the use of erythropoietin according to NICE TA323 if the patient is symptomatic of anaemia or where the haemoglobin is less than 8g/dL. At the start of each cycle the neutrophil count should be equal to or greater that 1x109/L and the platelets equal to or greater than 100x109/L. Haematological Toxicity Obinutuzumab Grade 3 or 4 haematological toxicity, febrile neutropenia or thrombocytopenic bleeding that delays treatment by Hold until the above parameters are met then restart at usual dose. less than 4 weeks Venetoclax Withhold for NCI-CTC grade 3 or 4 febrile neutropenia and/or infection, or other grade 4 haematological toxicities, except lymphopenia. Once the toxicity has resolved to NCICTC grade 1 or baseline level (recovery), therapy may be restarted at the same dose. Version 1 (May 2021) Page 2 of 18 CLL-Obinutuzumab-Venetoclax (Low Risk) Grade 3 or 4 haematological toxicity that delays treatment by more Discontinue than 4 weeks If the toxicity recurs, the dose reduction guidelines in table 2 should be followed when resuming treatment following recovery. A larger dose reduction may occur at the discretion of the responsible consultant. Discontinuation of venetoclax should be considered in patients who require dose reductions to less than 100 mg for more than 2 weeks Hepatic Impairment Patients with hepatic impairment should be closely monitored for signs and symptoms of toxicity. The safety and efficacy of obinutuzumab in patients with impaired hepatic function has not been established. No dose adjustments are required in patients with mild or moderate hepatic impairment. These patients should be monitored more closely for signs of toxicity at initiation and during the dose-titration phase as a trend for increased adverse events was observed in patients with moderate hepatic impairment in a population pharmacokinetic analysis. It is not recommended to administer venetoclax to patients with severe hepatic impairment as safety in this patient group has not been established. Renal Impairment Patients with evidence of impaired renal function should be carefully monitored as they are prone to additional myelosuppression. Dose adjustment is not considered necessary for obinutuzumab in those with mild to moderate renal impairment. For venetoclax no dose adjustment is required for patients with mild or moderate renal impairment. However, patients with reduced renal function (CrCl less than 80 ml/min) may require more intensive prophylaxis and monitoring to reduce the risk of tumour lysis syndrome at initiation and during the dose-titration phase. Safety in patients with severe renal impairment or on dialysis has not been established for venetoclax, and a recommended dose for these patients has not been determined. Venetoclax should be administered to patients with severe renal impairment only if the benefit outweighs the risk and patients should be monitored closely for signs of toxicity due to increased risk of TLS. Version 1 (May 2021) Page 3 of 18 CLL-Obinutuzumab-Venetoclax (Low Risk) Toxicity Obinutuzumab dose Grade 2 or 3 related organ/non- haematological toxicity Hold until less than or equal to grade 1 Grade than 4 2 non haematological weeks toxicity that delays treatment by more Discontinue Grade 4 related organ/non- haematological toxicity, severe haemorrhage, severe skin reaction, pneumonitis, severe arrhythmias or other severe cardiovascular events Discontinue Viral hepatitis or other serious infections; reactivation of hepatitis B Discontinue Other Toxicity Obinutuzumab dose Grade 2 or 3 related organ/non- haematological toxicity Hold until less than or equal to grade 1 Grade 2 non haematological toxicity that delays treatment by more Discontinue than 4 weeks Grade 4 related organ/non- haematological toxicity, severe haemorrhage, severe skin reaction, pneumonitis, severe arrhythmias or other severe cardiovascular events Discontinue Discontinue Viral hepatitis or other serious infections; reactivation of hepatitis B Obinutuzumab Progressive Multifocal Leukoencephalopathy Progressive multifocal leukoencephalopathy (PML) has been reported in patients treated with obinutuzumab. The diagnosis of PML should be considered in any patient presenting with new-onset or changes to pre- existing neurologic manifestations. The patient should be referred to a neurologist for the evaluation and treatment of PML. Infusion Reactions Obinutuzumab administration is associated with infusion related reactions, particularly during the first cycle. Most frequently reported symptoms associated with an infusion related reaction were nausea, chills, hypotension, pyrexia, vomiting, dyspnoea, flushing, hypertension, headache, tachycardia, and diarrhoea. Respiratory and cardiac symptoms such as bronchospasm, larynx and throat irritation, wheezing, laryngeal oedema and atrial fibrillation have also been reported. Anaphylaxis has been reported during administration of obinutuzumab. If a hypersensitivity reaction is suspected during infusion (e.g. symptoms typically occurring after previous exposure and very rarely with the first infusion), the infusion must be stopped and treatment permanently discontinued. Version 1 (May 2021) Page 4 of 18 CLL-Obinutuzumab-Venetoclax (Low Risk) Appropriate pre-medication must be administered before each infusion to reduce the risk of infusion related reactions. Infusion related reactions should be treated as described in the table below. Toxicity Grade Obinutuzumab Reduce the infusion rate by half 1-2 and treat symptoms. Restart the infusion once symptoms have resolved. Escalate infusion rate as tolerated at increments appropriate for treatment 1episode of grade 3 Hold infusion and treat the symptoms. Restart the infusion once the symptoms have resolved at no more than half the previous rate. Escalate the infusion rate as tolerated at increments appropriate for the treatment dose (see below) The day 1 (cycle 1) infusion rate may be increased back up to 25mg/hr after 60 minutes, but not increased further 2nd episode of grade 3 (during same Infusion must be stopped and therapy must be permanently discontinued or subsequent infusion) Grade 4 or acute life threatening respiratory reactions Infusion must be stopped and therapy must be permanently discontinued Tumour Lysis Syndrome (TLS) Tumour lysis syndrome (TLS) has been reported with obinutuzumab and in patients during the titration phase of venetoclax. Patients who are considered to be at risk of TLS (e.g. patients with a high tumour burden and/or a high circulating lymphocyte count (greater than 25x109/L) and/or renal impairment (CrCl less than 70 ml/min) should receive prophylaxis. Prophylaxis should consist of adequate hydration and administration of allopurinol or a suitable alternative such as rasburicase 7.5mg starting 12-24 hours prior to the infusion. All patients considered at risk should be carefully monitored during the initial days of treatment with a special focus on renal function, potassium, and uric acid values. Any additional guidelines according to standard practice should be followed. For example, the BTS guidelines. For treatment of TLS, correct electrolyte abnormalities, monitor renal function and fluid balance, and administer supportive care, including dialysis as indicated. Version 1 (May 2021) Page 5 of 18 CLL-Obinutuzumab-Venetoclax (Low Risk) Table 1 - Tumour Lysis Syndrome (TLS) Management Venetoclax Abnormality Dose Modification and Management Hyperkalaemia Potassium more than • Hold venetoclax until resolution ULN • Do an ECG and apply local trust hyperkalaemia policy • Recheck calcium, creatinine, phosphate, potassium and uric acid in 1 hour. If the potassium is less than ULN continue to monitor for TLS 2 and 4 hours later • If the potassium is more than or equal to 6.0mmol/l and/or symptomatic (e.g. muscle cramps, weakness, paraesthesia, nausea, vomiting or diarrhoea) then seek advice from a specialist renal team. Hyperuricaemia Uric acid more than than ULN • Hold venetoclax until resolution. • Consider giving rasburicase if not given in last 24 hours. Hypocalcaemia Adjusted calcium less • Hold the venetoclax until resolution. than LLN or patient symptomatic (e.g. muscle cramps, • Administer calcium gluconate 10% 10 to 20ml in 100ml sodium chloride 0.9% over 15minutes with ECG hypotension, tetany, monitoring. cardiac arrhythmias) in the presence of hypocalcaemia. • Recheck calcium, creatinine, phosphate, potassium and uric acid every one to two hours. Hyperphosphataemia Phosphate more than • Withold the venetoclax until resolution to less than ULN 1.45mmol/l • Discuss with the local renal team as a phosphate binder may be necessary (e.g. calcium carbonate, sevelamer, lanthanum) • Recheck calcium, creatinine, phosphate, potassium and uric acid in 1 hour. Creatinine Creatinine more than ULN Increase of more than or equal to 25% from baseline. • Hold the venetoclax until resolution • Administer intravenous fluids. • Recheck potassium, phosphate, uric acid, calcium and creatinine in 1 to 2 hours Version 1 (May 2021) Page 6 of 18 CLL-Obinutuzumab-Venetoclax (Low Risk) Regimen 28 day cycle for 6 cycles for treatment and 6 cycles for maintenance (12 cycles in total) Cycle 1 Drug Obinutuzumab Obinutuzumab Obinutuzumab Venetoclax Dose 100mg 900mg 1000mg 20mg Days 1 2 8, 15 22, 23, 24, 25, 26, 27, 28 Administration Intravenous infusion in 100ml sodium chloride 0.9% at a rate of 25mg/hour (over 240 minutes)* Intravenous infusion in 250ml sodium chloride 0.9% at a rate of 50mg/hour* Intravenous infusion in 250ml sodium chloride 0.9% at a rate of 100mg/hour* Oral Cycle 2 Drug Obinutuzumab Venetoclax Venetoclax Venetoclax Venetoclax Dose 1000mg 50mg 100mg 200mg 400mg Days 1 Administration Intravenous infusion in 250ml sodium chloride 0.9% at a rate of 100mg/hour* 1, 2, 3, 4, 5, 6, 7 Oral 8, 9, 10, 11, 12, 13, 14 Oral 15, 16, 17, 18, 19, 20, 21 Oral 22, 23, 24, 25, 26, 27, 28 Oral Cycle 3, 4, 5, 6 Drug Obinutuzumab Dose 1000mg Venetoclax 400mg Days 1 1-28 inclusive Administration Intravenous infusion in 250ml sodium chloride 0.9% at a rate of 100mg/hour* Oral Cycles 7, 8, 9, 10, 11, 12 Drug Venetoclax Dose 400mg Days 1-28 inclusive Administration Oral *Please see administration information below for infusion rates Dose Information Version 1 (May 2021) Page 7 of 18 CLL-Obinutuzumab-Venetoclax (Low Risk) • Venetoclax is available as 10mg, 50mg and 100mg film-coated tablets. • For patients who have had a dosing interruption lasting more than 1 week during the first 5 weeks of dose titration or more than 2 weeks when at the daily dose of 400mg, tumour lysis syndrome risk should be reassessed to determine if restarting at a reduced dose is necessary. Administration Information • Withhold antihypertensive treatments 12 hours before, during and 1 hour after the obinutuzumab infusion. Patients at acute risk of hypertensive crisis should be evaluated for the benefits and risks of withholding their antihypertensive medicines • Obinutuzumab standard infusion rates, in the absence of reactions are as follows; Cycle Day of Treatment Rate of Infusion 1 Day 1 Administer at 25mg/hour (over 240 minutes). Do not (100mg in 100ml) increase the rate 1 Day 2 (or day 1 continued) (900mg in 250ml) Start the administration at 50mg/hour The rate of the infusion can be escalated in increments 50 mg/hour every 30 minutes to a maximum rate of 400mg/hour of Day 8, 15 Infusions can be started at a rate of 100mg/hour and 1 increased by 100 mg/hour increments every 30 minutes to (1000mg in 250ml) a maximum of 400mg/hour 2 onwards All days (1000mg in 250ml) Infusions can be started at a rate of 100mg/hour and increased by 100mg/hour increments every 30 minutes to a maximum of 400mg/hour • The recommended dose of obinutuzumab is 1000 mg administered over day 1 and day 2, and on day 8 and day 15 of the first treatment cycle. Two infusion bags should be prepared for the infusion on days 1 and 2 (100 mg for day 1 and 900 mg for day 2). • If the first infusion (100mg) is completed without modifications of the infusion rate or interruptions, the second bag may be administered on the same day (no dose delay necessary, no repetition of premedication), provided that appropriate time, conditions and medical supervision are available throughout the infusion. If there are any modifications of the infusion rate or interruptions during the first 100 mg the second infusion (900mg) must be administered the following day. • Venetoclax film-coated tablets are for oral use. Patients should be instructed to swallow the tablets whole with a meal and water at approximately the same time each day. The tablets should not be chewed, crushed, or broken before swallowing. • During the dose-titration phase, venetoclax should be taken in the morning to facilitate laboratory monitoring. Version 1 (May 2021) Page 8 of 18 CLL-Obinutuzumab-Venetoclax (Low Risk) • It is imperative that the time of administration of the venetoclax is recorded on ARIA and the correct blood tests are taken at the correct time as part of any increase in the dose. • If a patient misses a dose of venetoclax within 8 hours of the time it is usually taken, the patient should take the missed dose as soon as possible on the same day. If a patient misses a dose by more than 8 hours, the patient should not take the missed dose and should resume the usual dosing schedule the following day. Additional Treatment • Antiemetics 15-30 minutes - metoclopramide 10mg three times a day when required (supplied on cycle 1 and 2 only) • Premedication for obinutuzumab infusion reactions - sodium chloride 0.9% 500ml intravenous infusion over 60 minutes then as follows; Cycle 1 days 1 and 2 Cycle 1 days 8 and 15 and Cycles 2, 3, 4, 5, 6 Pre-medication (60 minutes prior to obinutuzumab) All Patients Patients without infusion related reactions Methylprednisolone sodium succinate √ 80mg intravenous Chlorphenamine √ 10mg intravenous Paracetamol 1000mg oral √ √ Patients with grades 1-2 infusion related reactions Patients with a grade 3 infusion related reactions or with a lymphocyte count greater than 25x109/L √ √ √ √ √ On an as required basis; - chlorphenamine 10mg intravenous for infusion reactions - lorazepam 1mg oral for rigors - methylprednisolone sodium succinate 80mg intravenous for infusion reactions - paracetamol 1000mg oral for pyrexia Version 1 (May 2021) Page 9 of 18 CLL-Obinutuzumab-Venetoclax (Low Risk) - pethidine 25mg intravenous in 10ml sodium chloride 0.9% over 5 minutes for rigors following a verbal confirmation to administer from a doctor. • Allopurinol 300mg oral starting two days prior to day one cycle one for 7 days in total (not included in ARIA). Rasburicase 7.5mg intravenous infusion may be required for high risk individuals. • Anti-infective prophylaxis as follows; - consider aciclovir 400mg twice a day oral (consultants discretion, included on ARIA) - consider co-trimoxazole 960 mg once daily on Mon, Wed, Fri (consultants discretion, included on ARIA) Mouthwashes as per local formulary. For example; - nystatin 4ml four times daily (consultants discretion, not included on ARIA) - chlorhexidine 10ml four times daily (consultants discretion, not included on ARIA) • Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed. Additional Information • The National Patient Safety Alert on oral chemotherapy (NPSA/2008/RRR001) must be followed in relation to venetoclax. • It must be made clear to all staff, including those in the community, that venetoclax should only be prescribed under the supervision of a consultant haematologist. • Venetoclax interacts with many other medications. Always check for drug interactions. • Grapefruit products, Seville oranges, and starfruit (carambola) should be avoided during treatment with venetoclax. • Hypotension may occur during obinutuzumab intravenous infusions. Therefore, withholding of antihypertensive treatments should be considered for 12 hours prior to and throughout each obinutuzumab infusion and for the first hour after administration. Patients at acute risk of hypertensive crisis should be evaluated for the benefits and risks of withholding their anti-hypertensive medicine References 1. Dawson K, Moran M, Guindon K et al. Managing infusion related reactions for patients with chronic lymphocytic leukemia receiving obinutuzumab. Clin J Oncol Nursing 2016; 20 (2): 41-48 2. National Institute for Health and Care Excellence. Technology Appraisal Guidance 663 (2020). Venetoclax and obinutuzumab for untreated chronic lymphocytic leukemia. DOH:London Version 1 (May 2021) Page 10 of 18 CLL-Obinutuzumab-Venetoclax (Low Risk) REGIMEN SUMMARY Obinutuzumab-Venetoclax (Low Risk) Cycle 1 Day 1 1. Warning – TLS Assessment and Prevention Administration Instructions There is a risk of tumour lysis syndrome in CLL patients having this regimen. Ensure the patient has been assessed for TLS risk and prescribe the appropriate prophylaxis. This regimen is for low risk individuals. Allopurinol may be required prior to the obinutuzimab; it is not included in this protocol. It is included prior to the venetoclax dose escalations. Ensure arrangements are in place to monitor the patient appropriately. 2. Sodium chloride 0.9% 500ml intravenous infusion over 60 minutes 3. Chlorphenamine 10mg intravenous Administration Instructions Administer 60 minutes prior to obinutuzumab 4. Methylprednisolone sodium succinate 80mg intravenous Administration Instructions Administer 60 minutes prior to obinutuzumab 5. Paracetamol 1000mg oral Administration Instructions Please check if the patient takes regular paracetamol for pain control and take dose into account Administer 60 minutes prior to obinutuzumab 6. Obinutuzumab 100mg intravenous infusion in 100ml sodium chloride 0.9% over 240 minutes Administration Instructions Please refer to the protocol for information regarding infusion rates and infusion related reactions. These may be increased according to tolerance as per the protocol. 7. Chlorphenamine 10mg when required for infusion related reactions Administration Instructions For the relief of infusion related reactions 8. Lorazepam 1mg oral when required for rigors Administration Instructions For the relief of rigors 9. Methylprednisolone sodium succinate 80mg intravenous bolus when required for the relief of infusion related reactions Administration Instructions For the relief of infusion related reactions 10. Paracetamol 1000mg oral when required for pyrexia Administration Instructions For the relief of pyrexia. Please check if the patient takes regular paracetamol for pain control and take dose into account 11. Pethidine 25mg intravenous bolus in 10ml sodium chloride 0.9% over 5 minutes for the relief of rigors Administration Instructions For the relief of rigors following a verbal confirmation to administer from a doctor Version 1 (May 2021) Page 11 of 18 CLL-Obinutuzumab-Venetoclax (Low Risk) Day 2 12. Sodium chloride 0.9% 500ml intravenous infusion over 60 minutes 13. Chlorphenamine 10mg intravenous Administration Instructions Administer 60 minutes prior to obinutuzumab 14. Methylprednisolone sodium succinate 80mg intravenous Administration Instructions Administer 60 minutes prior to obinutuzumab 15. Paracetamol 1000mg oral Administration Instructions Please check if the patient takes regular paracetamol for pain control and take dose into account Administer 60 minutes prior to obinutuzumab 16. Obinutuzumab 900mg intravenous infusion in 250ml sodium chloride 0.9% Administration Instructions Please refer to the protocol for information regarding infusion rates and infusion related reactions. These may be increased according to tolerance as per the protocol. 17. Chlorphenamine 10mg when required for infusion related reactions Administration Instructions For the relief of infusion related reactions 18. Lorazepam 1mg oral when required for rigors Administration Instructions For the relief of rigors 19. Methylprednisolone sodium succinate 80mg intravenous bolus when required for the relief of infusion related reactions Administration Instructions For the relief of infusion related reactions 20. Paracetamol 1000mg oral when required for pyrexia Administration Instructions For the relief of pyrexia. Please check if the patient takes regular paracetamol for pain control and take dose into account 21. Pethidine 25mg intravenous bolus in 10ml sodium chloride 0.9% over 5 minutes for the relief of rigors Administration Instructions For the relief of rigors following a verbal confirmation to administer from a doctor Day 8 22. Sodium chloride 0.9% 500ml intravenous infusion over 60 minutes 23. Chlorphenamine 10mg intravenous when required for infusion related reactions Administration Instructions Please refer to the protocol. Administer 60 minutes prior to obinutuzumab if there has been a grade 1 or above infusion related reaction or with a lymphocyte count greater than 25x109/L 24. Methylprednisolone sodium succinate 80mg intravenous when required for infusion related reactions Administration Instructions Please refer to the protocol. Administer 60 minutes prior to obinutuzumab if there has been a grade 3 or above infusion related reaction Version 1 (May 2021) Page 12 of 18 CLL-Obinutuzumab-Venetoclax (Low Risk) 25. Paracetamol 1000mg oral Administration Instructions Please check if the patient takes regular paracetamol for pain control and take dose into account. Administer 60 minutes prior to obinutuzumab 26. Obinutuzumab 1000mg intravenous infusion in 250ml sodium chloride 0.9% Administration Instructions Please refer to the protocol for information regarding infusion rates and infusion related reactions. These may be increased according to tolerance as per the protocol. 27. Chlorphenamine 10mg when required for infusion related reactions Administration Instructions For the relief of infusion related reactions or with a lymphocyte count greater than 25x109/L 28. Lorazepam 1mg oral when required for rigors Administration Instructions For the relief of rigors 29. Methylprednisolone sodium succinate 80mg intravenous bolus when required for the relief of infusion related reactions Administration Instructions For the relief of infusion related reactions 30. Paracetamol 1000mg oral when required for pyrexia Administration Instructions For the relief of pyrexia. Please check if the patient takes regular paracetamol for pain control and take dose into account 31. Pethidine 25mg intravenous bolus in 10ml sodium chloride 0.9% over 5 minutes for the relief of rigors Administration Instructions For the relief of rigors following a verbal confirmation to administer from a doctor Day 15 32. Sodium chloride 0.9% 500ml intravenous infusion over 60 minutes 33. Chlorphenamine 10mg intravenous when required for infusion related reactions Administration Instructions Please refer to the protocol. Administer 60 minutes prior to obinutuzumab if there has been a grade 1 or above infusion related reaction or with a lymphocyte count greater than 25x109/L 34. Methylprednisolone sodium succinate 80mg intravenous when required for infusion related reactions Administration Instructions Please refer to the protocol. Administer 60 minutes prior to obinutuzumab if there has been a grade 3 or above infusion related reaction 35. Paracetamol 1000mg oral Administration Instructions Please check if the patient takes regular paracetamol for pain control and take dose into account. Administer 60 minutes prior to obinutuzumab 36. Obinutuzumab 1000mg intravenous infusion in 250ml sodium chloride over 240 minutes Administration Instructions Please refer to the protocol for information regarding infusion rates and infusion related reactions. These may be increased according to tolerance as per the protocol. 37. Chlorphenamine 10mg when required for infusion related reactions Administration Instructions Version 1 (May 2021) Page 13 of 18 CLL-Obinutuzumab-Venetoclax (Low Risk) For the relief of infusion related reactions or with a lymphocyte count greater than 25x109/L 38. Lorazepam 1mg oral when required for rigors Administration Instructions For the relief of rigors 39. Methylprednisolone sodium succinate 80mg intravenous bolus when required for the relief of infusion related reactions Administration Instructions For the relief of infusion related reactions 40. Paracetamol 1000mg oral when required for pyrexia Administration Instructions For the relief of pyrexia. Please check if the patient takes regular paracetamol for pain control and take dose into account 41. Pethidine 25mg intravenous bolus in 10ml sodium chloride 0.9% over 5 minutes for the relief of rigors Administration Instructions For the relief of rigors following a verbal confirmation to administer from a doctor Take Home Medicines (day 1 only) 42. Allopurinol 300mg once a day oral starting 72 hours before the first dose of venetoclax Administration Instructions Start 72 hours prior to the administration of the first dose of venetoclax and stop after 7 days of the 400mg dose escalation. Please supply 38 days or nearest equivalent original pack size. 43. Metoclopramide 10mg three times a day when required for the relief of nausea Administration Instructions Please supply 28 tablets or nearest original pack size 44. Aciclovir 400mg twice a day oral for 28 days 45. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday for 28 days 46. Warning Consider Mouthwashes Administration Instructions Consider prescribing mouthwash (from favourites) such as - nystatin 4ml four times a day - chlorhexidine 10ml four times a day Take Home Medicines (Day 22 only) 47. Warning – TLS prevention Administration Instructions There is a risk of tumour lysis syndrome in CLL patients having this regimen. Ensure the patient has been assessed for TLS risk and prescribe the appropriate prophylaxis. This regimen is for low risk individuals. Please check the patient has taken the prescribed allopurinol. Patients should be adequately hydrated during the dose-titration phase to reduce the risk of TLS. Patients should be instructed to drink plenty of water daily starting 2 days before and throughout the dose-titration phase. Patients should be particularly instructed to drink 1.5 to 2L of water daily, 2 days prior to and the days of dosing at initiation and each subsequent dose increase. Intravenous fluids should be administered as indicated based on overall risk of TLS or for those who cannot maintain an adequate level of oral hydration. Ensure arrangements are in place to monitor the patient appropriately. Version 1 (May 2021) Page 14 of 18 CLL-Obinutuzumab-Venetoclax (Low Risk) 48. Venetoclax 20mg once a day for 7 days oral Administration Instructions Take with or just after food. Take with a full glass of water. Oral SACT Cycle 2 49. Sodium chloride 0.9% 500ml intravenous infusion over 60 minutes 50. Chlorphenamine 10mg intravenous when required for infusion related reactions Administration Instructions Please refer to the protocol. Administer 60 minutes prior to obinutuzumab if there has been a grade 1 or above infusion related reaction or with a lymphocyte count greater than 25x109/L 51. Methylprednisolone sodium succinate 80mg intravenous when required for infusion related reactions Administration Instructions Please refer to the protocol. Administer 60 minutes prior to obinutuzumab if there has been a grade 3 or above infusion related reactions 52. Paracetamol 1000mg oral Administration Instructions Please check if the patient takes regular paracetamol for pain control and take dose into account. Administer 60 minutes prior to obinutuzumab 53. Obinutuzumab 1000mg intravenous infusion in 250ml sodium chloride 0.9% Administration Instructions Please refer to the protocol for information regarding infusion rates and infusion related reactions. These may be increased according to tolerance as per the protocol. 54. Chlorphenamine 10mg when required for infusion related reactions Administration Instructions For the relief of infusion related reactions or with a lymphocyte count greater than 25x109/L 55. Lorazepam 1mg oral when required for rigors Administration Instructions For the relief of rigors 56. Methylprednisolone sodium succinate 80mg intravenous bolus when required for the relief of infusion related reactions Administration Instructions For the relief of infusion related reactions 57. Paracetamol 1000mg oral when required for pyrexia Administration Instructions For the relief of pyrexia. Please check if the patient takes regular paracetamol for pain control and take dose into account 58. Pethidine 25mg intravenous bolus in 10ml sodium chloride 0.9% over 5 minutes for the relief of rigors Administration Instructions For the relief of rigors following a verbal confirmation to administer from a doctor Version 1 (May 2021) Page 15 of 18 CLL-Obinutuzumab-Venetoclax (Low Risk) Take Home Medicines Day 1 59. Venetoclax 50mg once a day for 7 days oral Administration Instructions Take with or just after food. Take with a full glass of water. Oral SACT 60. Aciclovir 400mg twice a day oral for 28 days 61. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday for 28 days Day 8 62. Venetoclax 100mg once a day for 7 days oral Administration Instructions Take with or just after food. Take with a full glass of water. Oral SACT Day 15 63. Venetoclax 200mg once a day for 7 days oral Administration Instructions Take with or just after food. Take with a full glass of water. Oral SACT Day 22 64. Venetoclax 400mg once a day for 7 days oral Administration Instructions Take with or just after food. Take with a full glass of water. Oral SACT Cycles 3, 4, 5, 6 65. Sodium chloride 0.9% 500ml intravenous infusion over 60 minutes 66. Chlorphenamine 10mg intravenous when required for infusion related reactions Administration Instructions Please refer to the protocol. Administer 60 minutes prior to obinutuzumab if there has been a grade 1 or above infusion related reaction or with a lymphocyte count greater than than 25x109/L 67. Methylprednisolone sodium succinate 80mg intravenous when required for infusion related reactions Administration Instructions Please refer to the protocol. Administer 60 minutes prior to obinutuzumab if there has been a grade 3 or above infusion related reaction 68. Paracetamol 1000mg oral Administration Instructions Please check if the patient takes regular paracetamol for pain control and take dose into account. Administer 60 minutes prior to obinutuzumab 69. Obinutuzumab 1000mg intravenous infusion in 250ml sodium chloride 0.9% Administration Instructions Version 1 (May 2021) Page 16 of 18 CLL-Obinutuzumab-Venetoclax (Low Risk) Please refer to the protocol for information regarding infusion rates and infusion related reactions. These may be increased according to tolerance as per the protocol. 70. Chlorphenamine 10mg when required for infusion related reactions Administration Instructions For the relief of infusion related reactions or with a lymphocyte count greater than 25x109/L 71. Lorazepam 1mg oral when required for rigors Administration Instructions For the relief of rigors 72. Methylprednisolone sodium succinate 80mg intravenous bolus when required for the relief of infusion related reactions Administration Instructions For the relief of infusion related reactions 73. Paracetamol 1000mg oral when required for pyrexia Administration Instructions For the relief of pyrexia. Please check if the patient takes regular paracetamol for pain control and take dose into account 74. Pethidine 25mg intravenous bolus in 10ml sodium chloride 0.9% over 5 minutes for the relief of rigors Administration Instructions For the relief of rigors following a verbal confirmation to administer from a doctor Take Home Medicines Day 1 75. Venetoclax 400mg once a day for 28 days oral Administration Instructions Take with or just after food. Take with a full glass of water. Oral SACT 76. Aciclovir 200mg twice a day oral for 28 days 77. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday for 28 day Cycles 7, 8, 9, 10, 11, 12 79. Venetoclax 400mg once a day for 28 days oral Administration Instructions Take with or just after food. Take with a full glass of water. Oral SACT 80. Aciclovir 400mg twice a day oral for 28 days 81. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday for 28 days Version 1 (May 2021) Page 17 of 18 CLL-Obinutuzumab-Venetoclax (Low Risk) DOCUMENT CONTROL Version Date Amendment Written By Approved By 1 May 2021 None Dr Deborah Wright Pharmacist Prof F Forconi Consultant Haematologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors that occur as a result of following these guidelines. These protocols are only one source of information. They should be read in conjunction with the latest Summary of Product Characteristics and published information. Version 1 (May 2021) Page 18 of 18 CLL-Obinutuzumab-Venetoclax (Low Risk)
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/CLL/ObinutuzumabVenetoclax-LowRisk.pdf

Blinatumomab

Description: Chemotherapy Protocol Acute lymphoblastic leukaemia (ALL) Blinatumomab (3, 4 day) Regimen • ALL – Blinatumomab (3, 4 day schedule) Indication • Treatment of Philadelphia-chromosome-negative relapsed or refractory B-precursor acute lymphoblastic leukaemia. Toxicity Drug Adverse Effect Blinatumomab Cytokine release syndrome, tumour lysis syndrome, neurological toxicity, elevated liver enzymes. The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring • FBC, U&Es and LFTs on day 1 of the cycle • Hepatitis B, C and HIV serology prior to cycle one Dose Modifications • Please discuss all dose reductions / delays with the relevant consultant before prescribing, if appropriate. The approach may be different depending on the clinical circumstances. • Consideration to discontinue blinatumomab temporarily or permanently as appropriate should be made in the case of the following severe (NCI-CTC grade 3) or life-threatening (NCI-CTC grade 4) toxicities. For example, cytokine release syndrome, tumour lysis syndrome, neurological toxicity, elevated liver enzymes and any other clinically relevant toxicities. • If the treatment is interrupted for more than four hours it is recommended that the patient is examined by a heathcare professional. If the interruption of treatment after an adverse event is 7 days or less, continue the same cycle to a total of 28 days of infusion inclusive of days before and after the interruption in that cycle. If an interruption due to an adverse event is longer than 7 days, start a new cycle. If the toxicity takes more than 14 days to resolve, discontinue blinatumomab permanently, except if described differently in the table below: Version 1 (July 2017) Page 1 of 14 ALL-Blinatumomab (3, 4 day schedule) Toxicity Action Cytokine release Grade 3 syndrome, Interrupt blinatumomab until resolved, then restart at 9micrograms/day. tumour lysis Escalate to 28micrograms/day after 7 days if the toxicity does not recur. syndrome Grade 4 Discontinue blinatumomab permanently. Neurological toxicity Convulsion Discontinue blinatumomab permanently if more than one convulsion occurs. Grade 3 • Interrupt blinatumomab until no more than grade 1 (mild) and for at least 3 days, then restart blinatumomab at 9micrograms/day. Escalate to 28micrograms/day after 7 days if the toxicity does not recur. • On re-initiation, pre-medicate with a 24mg dose of dexamethasone. Then reduce dexamethasone step-wise over 4 days. • If the toxicity occurred at 9micrograms/day, or if the toxicity takes more than 7 days to resolve, discontinue blinotumumab permanently. Grade 4 Discontinue blinatumomab permanently. Elevated liver enzymes Grade 3 If clinically relevant, interrupt blinatumomab until no more than grade 1 (mild), then restart blinatumomab at 9micrograms/day. Escalate to 28micrograms/day after 7 days if the toxicity does not recur. Grade 4 Consider discontinuing blinatumomab permanently. Other clinically relevant (as determined by treating physician) adverse reactions Grade 3 Interrupt blinatumomab until no more than grade 1 (mild), then restart blinatumomab at 9micrograms/day. Escalate to 28micrograms/day after 7 days if the toxicity does not recur. Grade 4 Consider discontinuing blinatumomab permanently. *Based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 3 is severe, and grade 4 is life-threatening. Haematological No dose modifications for haematological toxicity are necessary for blinatumomab. If treatment with blinatumomab is not tolerated it should be stopped. Version 1 (July 2017) Page 2 of 14 ALL-Blinatumomab (3, 4 day schedule) Hepatic Impairment Based on pharmacokinetic analyses, dose adjustment is not necessary in patients with mild to moderate hepatic dysfunction. The safety and efficacy of blinatumomab have not been studied in patients with severe hepatic impairment. See table above. Renal Impairment Based on pharmacokinetic analyses, dose adjustment is not necessary in patients with mild to moderate renal dysfunction. The safety and efficacy of blinotumumab have not been studied in patients with severe renal impairment. Patients with evidence of impaired renal function should be carefully monitored as they are prone to additional myelosuppression. Elderly No dose adjustment is necessary in elderly patients (greater than or equal to 65 years of age). There is limited experience with blinatumomab in patients greater than or equal to 75 years of age. Other Dose reductions or interruptions in therapy are not necessary for those toxicities that are considered unlikely to be serious or life threatening. For example, alopecia, altered taste or nail changes (see table above). Cytokine Release Syndrome (CRS) and Infusion Related Reactions Premedication with dexamethasone is intended to prevent CRS events associated with blinatumomab treatment. Serious adverse events that may be signs and symptoms of CRS included pyrexia, asthenia, headache, hypotension, total bilirubin increased, and nausea. The median time to onset of a CRS event was 2 days. Patients should be closely monitored for signs or symptoms of these events. Disseminated intravascular coagulation and capillary leak syndrome (e.g. hypotension, hypoalbuminaemia, oedema and haemoconcentration) have been commonly associated with CRS. Patients experiencing capillary leak syndrome should be managed promptly. Infusion Related Reactions Infusion reactions may be clinically indistinguishable from manifestations of CRS and include symptoms such as rash, wheezing, flushing, breathlessness, hypotension, facial swelling. The infusion reactions were generally rapid, occurring within 48 hours after initiating infusion. However some patients reported delayed onset of infusion reactions or in later cycles. Patients should be observed closely for infusion reactions, especially during the initiation of the first and second treatment cycles and treated appropriately. Anti-pyretic use (e.g. paracetamol) is recommended to help reduce pyrexia during the first 48 hours of each cycle. Version 1 (July 2017) Page 3 of 14 ALL-Blinatumomab (3, 4 day schedule) Neurological In the pivotal study 52% of patients experienced one or more neurologic adverse reactions (including psychiatric disorders). NCI-CTC grade 3 or higher neurologic events following initiation of blinatumomab administration included encephalopathy, seizures, speech disorders, disturbances in consciousness, confusion, disorientation, and coordination and balance disorders. The median time from initiation of blinatumomab to onset of a neurologic event was 9 days. The majority of events resolved after treatment interruption. It is recommended that a neurological examination be performed in patients prior to starting therapy and that patients be clinically monitored for signs and symptoms of neurologic events (e.g. writing test). Management of these signs and symptoms to resolution may require either temporary interruption or permanent discontinuation of treatment. Elderly patients experience a higher rate of neurological events. Counsel patients on the potential neurologic effects and advise patients not to drive, use heavy machinery, or engage in hazardous activities while on treatment and to promptly report any neurological symptoms. Tumour lysis syndrome Tumour lysis syndrome (TLS), which may be life-threatening or fatal (grade equal to or greater than 4) has been observed in patients receiving blinatumomab. Appropriate prophylactic measures including aggressive hydration and anti-hyperuricaemic therapy (such as allopurinol or rasburicase) should be used for the prevention and treatment of TLS during treatment, especially in patients with higher leukocytosis or a high tumour burden. Patients should be closely monitored for signs or symptoms of TLS, including renal function and fluid balance in the first 48 hours after the first infusion. In clinical studies, patients with moderate renal impairment showed an increased incidence of TLS compared with patients with mild renal impairment or normal renal function, Management of these events may require either temporary interruption or discontinuation of blinatumomab. Regimen 42 day cycle for up to 5 cycles Patients will receive an initial 2 cycles of treatment. Patients who have achieved complete remission after 2 cycles may receive up to 3 additional cycles, based on an individual benefits-risks assessment. Consider the administration of pre-phase corticosteroid treatment prior to cycle one if the peripheral blast count is greater than 15% or bone marrow blasts are greater than 50%. This is not included on ARIA Version 1 (July 2017) Page 4 of 14 ALL-Blinatumomab (3, 4 day schedule) Cycle 1 Drug Dose Blinatumomab 9 micrograms/day 28 micrograms/day Days 1 to 7 (7 days) 8 to 28 (21 days) Administration Continuous intravenous infusion in 240ml sodium chloride 0.9% at a rate of 2.5ml/hour via a pump (please see administration instructions below for days the pump is changed). Cycle 2, 3, 4, 5 Drug Dose Blinatumomab 28 micrograms/day Days 1 to 28 (28 days) Administration Continuous intravenous infusion in 240ml sodium chloride 0.9% at a rate of 2.5ml/hour via a pump (please see administration instructions below for days the pump is changed). Dose Information • Blinatumomab is a set dose and does not require dose banding • Dosing errors have been observed with blinatumomab treatment. It is very important that the instructions for administration are strictly followed to minimise this risk. • The administration period must not exceed 28 days in total in any given cycle Administration Information • Central venous access is required. Infuse through a dedicated lumen. • Blinatumomab should be administered as a continuous intravenous infusion delivered at a constant flow rate using a pump system. All infusions will contain sufficient volume and drug for a 96 hour infusion, although they will be administered over alternate 72 and 96 hours. The bag will contain; - 9microgram/day – 41.25microgram in 275ml - 28microgram/day – 133.75microgram in 275ml • ARIA has been set up to administer the first, third, fifth and seventh infusions of the same cycle over 72 hours. This means that treatment must start on a Monday, Tuesday or Friday. The infusion will contain sufficient drug and volume for 96 hours and must be programmed to stop after 72 hours. The bag must then be discarded. The second, fourth, sixth and eighth infusion of each cycle will be administered over 96 hours. Ensure the pump is set to stop at the correct times. • Do not flush infusion lines into the patient, as it will cause an inadvertent bolus of blinatumomab to be administered. The line must be replaced with every change of the infusion bag. Version 1 (July 2017) Page 5 of 14 ALL-Blinatumomab (3, 4 day schedule) • Administer blinatumomab through a Polyolefin, PVC non-DEHP, or EVA intravenous infusion line with a low protein-binding 0.2µm in-line filter. • The administration period must not exceed more that 28 days in any given cycle • The days of administration may need to be adjusted on ARIA depending on the time of the start of the day one infusion. Additional Therapy • Consider the administration of pre-phase corticosteroid treatment prior to cycle one if the peripheral blast count is greater than 15% or bone marrow blasts are greater than 50%. This is not included on ARIA • Dexamethasone 20mg or equivalent intravenous 60 minutes prior to day 1 blinatumomab on every cycle • Paracetamol 1000mg four times a day for the first 48 hours of the day 1 blinatumomab on every cycle oral • Allopurinol 300mg daily for 7 days (cycle 1 only) oral • Anti-infective prophylaxis with - aciclovir 400mg twice a day oral - co-trimoxazole 960mg once a day on Mondays, Wednesdays and Fridays oral - fluconazole 50mg once a day oral • For the treatment of infusion related reactions - chlorpheniramine 10mg intravenous when required - hydrocortisone 100mg intravenous when required - pethidine 12.5-25mg when required for rigors following instruction from a medical practitioner - salbutamol 2.5mg nebulised when required - pethidine 12.5-25mg intravenous when required for rigors • Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed. Additional Information • Patients should be encouraged to drink at least three litres of fluid per 24 hours • Cycle one and two are started in the hospital setting. It is recommended the patient remain an in-patient for the first 9 days of cycle one and at least two days of cycle two. Take home (supportive) medicines have been included in this protocol. If an inpatient stay is necessary these must be prescribed on the in-patient chart Version 1 (July 2017) Page 6 of 14 ALL-Blinatumomab (3, 4 day schedule) Coding • Procurement – X71.3 • Delivery – X72.2 References 1. National Institute for Health and Clinical Excellance (2017). Blinatumomab for previously treated Philadelphia-chromosomenegative acute lymphoblastic leukaemia. Technology appraisal guidance [TA450] Published date: 28 June 2017 2. Kantarilan H, Stein A, Gokbuget N et al. Blinatumomab versus Chemotherapy for Advanced Acute Lymphoblastic Leukemia. N Eng J Med 2017; 376 (9):836-847. Version 1 (July 2017) Page 7 of 14 ALL-Blinatumomab (3, 4 day schedule) REGIMEN SUMMARY Blinatumomab (3, 4 day schedule) Cycle 1 Day 1 1. Warning – Check Supportive Medicines Prescribed (if I/P) Administration Instructions If an in-patient ensure the following medicines are prescribed; 1. Paracetamol 1000mg four times a day for the first 48 hours then as required oral (see below) 2. Aciclovir 400mg twice a day 3. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday only oral 4. Fluconazole 50mg once a day oral 5. Allopurinol 300mg once a day for 7 days oral 6. Chlorphenamine 10mg intravenous when required for infusion related reactions 7. Hydrocortisone 100mg intravenous when required for infusion related reactions 8. Salbutamol 2.5mg nebulised when required for infusion related reactions 9. Pethidine 12.5-25mg intravenous when required for rigors (following medical instruction) 2. Dexamethasone 20mg or equivalent intravenous Administration Instructions Administer 20mg or equivalent dose intravenously 60 minutes before the start of the blinatumomab infusion 3. Paracetamol 1000mg oral Administration Instructions Administer 60 minutes before the start of the blinatumomab infusion. Check if the patient has already taken paracetamol (maximum dose is 4000mg/24 hours) 4. Blinatumomab 9micrograms/day by continuous intravenous infusion in 240ml sodium chloride 0.9% at a rate of 2.5ml/hour for 72 hours via a pump Administration Instructions Central venous access is required. Infuse through a dedicated lumen. Blinatumomab should be administered as a continuous intravenous infusion delivered at a constant flow rate using a pump. All infusions will contain sufficient volume and drug for a 96 hour infusion, although they will be administered over alternate 72 and 96 hours. The bag will contain; - 9microgram/day – 41.25microgram in 275ml - 28microgram/day – 133.75microgram in 275ml ARIA has been set up to administer the first, third, fifth and seventh infusions of the same cycle over 72 hours. This means that treatment must start on a Monday, Tuesday or Friday. The pump will contain sufficient drug and volume for 96 hours and must be programmed to stop after 72 hours. The bag must then be discarded. The second, fourth, sixth and eighth infusion of each cycle will be administered over 96 hours. Ensure the pump is set to stop at the correct times. Do not flush the remaining volume left in the infusion line into the patient, as it will cause an inadvertent bolus of blinatumomab to be administered. The line must be replaced with every change of pump. Administer blinatumomab through a Polyolefin, PVC non-DEHP, or EVA intravenous infusion line with a low proteinbinding 0.2µm in-line filter. The administration period must not exceed more that 28 days in any given cycle. The day of administration may need to be adjusted on ARIA depending on the time of the start of the day one infusion 5. Chlorpheniramine 10mg intravenous when required for the relief of infusion related reactions 6. Hydrocortisone 100mg intravenous when required for the relief of infusion related reactions Version 1 (July 2017) Page 8 of 14 ALL-Blinatumomab (3, 4 day schedule) 7. Pethidine 25mg when required for the relief of rigors Administration Instructions For the relief of rigors following a verbal confirmation from a doctor that the dose is to be given. 8. Salbutamol 2.5mg nebulised when required for the relief of infusion related reactions Cycle 1 Day 4 9. Blinatumomab 9micrograms/day by continuous intravenous infusion in 240ml sodium chloride 0.9% at a rate of 2.5ml/hour for 96 hours via a pump Administration Instructions Central venous access is required. Infuse through a dedicated lumen. Blinatumomab should be administered as a continuous intravenous infusion delivered at a constant flow rate using a pump. All infusions will contain sufficient volume and drug for a 96 hour infusion, although they will be administered over alternate 72 and 96 hours. The bag will contain; - 9microgram/day – 41.25microgram in 275ml - 28microgram/day – 133.75microgram in 275ml ARIA has been set up to administer the first, third, fifth and seventh infusions of the same cycle over 72 hours. This means that treatment must start on a Monday, Tuesday or Friday. The pump will contain sufficient drug and volume for 96 hours and must be programmed to stop after 72 hours. The bag must then be discarded. The second, fourth, sixth and eighth infusion of each cycle will be administered over 96 hours. Ensure the pump is set to stop at the correct times. Do not flush the remaining volume in the infusion line into the patient, as it will cause an inadvertent bolus of blinatumomab to be administered. The line must be replaced with every change of pump. Administer blinatumomab through a Polyolefin, PVC non-DEHP, or EVA intravenous infusion line with a low proteinbinding 0.2µm in-line filter. The administration period must not exceed more that 28 days in any given cycle. The day of administration may need to be adjusted on ARIA depending on the time of the start of the day one infusion 10. Chlorpheniramine 10mg intravenous when required for the relief of infusion related reactions 11. Hydrocortisone 100mg intravenous when required for the relief of infusion related reactions 12. Pethidine 25mg when required for the relief of rigors Administration Instructions For the relief of rigors following a verbal confirmation from a doctor that the dose is to be given. 13. Salbutamol 2.5mg nebulised when required for the relief of infusion related reactions Cycle 1 Days 8, 15, 22 14. Blinatumomab 28micrograms/day by continuous intravenous infusion in 240ml sodium chloride 0.9% at a rate of 2.5ml/hour for 72 hours via a pump Administration Instructions Administration Instructions Central venous access is required. Infuse through a dedicated lumen. Blinatumomab should be administered as a continuous intravenous infusion delivered at a constant flow rate using a pump. All infusions will contain sufficient volume and drug for a 96 hour infusion, although they will be administered over alternate 72 and 96 hours. The bag will contain; - 9microgram/day – 41.25microgram in 275ml - 28microgram/day – 133.75microgram in 275ml Version 1 (July 2017) Page 9 of 14 ALL-Blinatumomab (3, 4 day schedule) ARIA has been set up to administer the first, third, fifth and seventh infusions of the same cycle over 72 hours. This means that treatment must start on a Monday, Tuesday or Friday. The pump will contain sufficient drug and volume for 96 hours and must be programmed to stop after 72 hours. The bag must then be discarded. The second, fourth, sixth and eighth infusion of each cycle will be administered over 96 hours. Ensure the pump is set to stop at the correct times. Do not flush the remaining volume left in the infusion line into the patient, as it will cause an inadvertent bolus of blinatumomab to be administered. The line must be replaced with every change of pump. Administer blinatumomab through a Polyolefin, PVC non-DEHP, or EVA intravenous infusion line with a low proteinbinding 0.2µm in-line filter. The administration period must not exceed more that 28 days in any given cycle. The day of administration may need to be adjusted on ARIA depending on the time of the start of the day one infusion 15. Chlorpheniramine 10mg intravenous when required for the relief of infusion related reactions 16. Hydrocortisone 100mg intravenous when required for the relief of infusion related reactions 17. Pethidine 25mg when required for the relief of rigors Administration Instructions For the relief of rigors following a verbal confirmation from a doctor that the dose is to be given. 18. Salbutamol 2.5mg nebulised when required for the relief of infusion related reactions Cycle 1 Days 11, 18, 25 19. Blinatumomab 28micrograms/day by continuous intravenous infusion in 240ml sodium chloride 0.9% at a rate of 2.5ml/hour for 96 hours via a pump Administration Instructions Central venous access is required. Infuse through a dedicated lumen. Blinatumomab should be administered as a continuous intravenous infusion delivered at a constant flow rate using a pump. All infusions will contain sufficient volume and drug for a 96 hour infusion, although they will be administered over alternate 72 and 96 hours. The bag will contain; - 9microgram/day – 41.25microgram in 275ml - 28microgram/day – 133.75microgram in 275ml ARIA has been set up to administer the first, third, fifth and seventh infusions of the same cycle over 72 hours. This means that treatment must start on a Monday, Tuesday or Friday. The pump will contain sufficient drug and volume for 96 hours and must be programmed to stop after 72 hours. The bag must then be discarded. The second, fourth, sixth and eighth infusion of each cycle will be administered over 96 hours. Ensure the pump is set to stop at the correct times. Do not flush the remaining volume left in the infusion line into the patient, as it will cause an inadvertent bolus of blinatumomab to be administered. The line must be replaced with every change of pump. Administer blinatumomab through a Polyolefin, PVC non-DEHP, or EVA intravenous infusion line with a low proteinbinding 0.2µm in-line filter. The administration period must not exceed more that 28 days in any given cycle. The day of administration may need to be adjusted on ARIA depending on the time of the start of the day one infusion 20. Chlorpheniramine 10mg intravenous when required for the relief of infusion related reactions 21. Hydrocortisone 100mg intravenous when required for the relief of infusion related reactions Version 1 (July 2017) Page 10 of 14 ALL-Blinatumomab (3, 4 day schedule) 22. Pethidine 25mg when required for the relief of rigors Administration Instructions For the relief of rigors following a verbal confirmation from a doctor that the dose is to be given. 23. Salbutamol 2.5mg nebulised when required for the relief of infusion related reactions Take Home Medicines (day 1 only) 24. Paracetamol 1000mg four times a day for days 1 and 2 of the cycle then 1000mg four times a day as required 25. Allopurinol 300mg once a day for 7 days oral 26. Aciclovir 400mg twice a day for 42 days oral 27. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday only for 42 days 28. Fluconaole 50mg once a day for 42 days oral Cycle 2, 3, 4, 5 Day 1 29. Warning – Check Supportive Medicines Prescribed (if I/P) Administration Instructions If an in-patient ensure the following medicines are prescribed; 10. Paracetamol 1000mg four times a day for the first 48 hours then as required oral (see below) 11. Aciclovir 400mg twice a day 12. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday only oral 13. Fluconazole 50mg once a day oral 14. Allopurinol 300mg once a day for 7 days oral 15. Chlorphenamine 10mg intravenous when required for infusion related reactions 16. Hydrocortisone 100mg intravenous when required for infusion related reactions 17. Salbutamol 2.5mg nebulised when required for infusion related reactions 18. Pethidine 25mg intravenous when required for rigors (following medical instruction) 30. Dexamethasone 20mg or equivalent intravenous Administration Instructions Administer 60 minutes before the start of the blinatumomab infusion 31. Paracetamol 1000mg oral Administration Instructions Administer 60 minutes before the start of the blinatumomab infusion. Check if the patient has already taken paracetamol (maximum dose is 4000mg/24 hours) 32. Blinatumomab 28micrograms/day by continuous intravenous infusion in 240ml sodium chloride 0.9% at a rate of 2.5ml/hour for 72 hours via a pump Administration Instructions Administration Instructions Central venous access is required. Infuse through a dedicated lumen. Blinatumomab should be administered as a continuous intravenous infusion delivered at a constant flow rate using a pump. All infusions will contain sufficient volume and drug for a 96 hour infusion, although they will be administered over alternate 72 and 96 hours. The bag will contain; - 9microgram/day – 41.25microgram in 275ml - 28microgram/day – 133.75microgram in 275ml ARIA has been set up to administer the first, third, fifth and seventh infusions of the same cycle over 72 hours. This means that treatment must start on a Monday, Tuesday or Friday. The pump will contain sufficient drug and volume for 96 hours and must be programmed to stop after 72 hours. The bag must then be discarded. The second, fourth, sixth and eighth infusion of each cycle will be administered over 96 hours. Ensure the pump is set to stop at the correct times. Version 1 (July 2017) Page 11 of 14 ALL-Blinatumomab (3, 4 day schedule) Do not flush the remaining volume left in the infusion line into the patient, as it will cause an inadvertent bolus of blinatumomab to be administered. The line must be replaced with every change of pump. Administer blinatumomab through a Polyolefin, PVC non-DEHP, or EVA intravenous infusion line with a low proteinbinding 0.2µm in-line filter. The administration period must not exceed more that 28 days in any given cycle. The day of administration may need to be adjusted on ARIA depending on the time of the start of the day one infusion 33. Chlorpheniramine 10mg intravenous when required for the relief of infusion related reactions 34. Hydrocortisone 100mg intravenous when required for the relief of infusion related reactions 35. Pethidine 25mg when required for the relief of rigors Administration Instructions For the relief of rigors following a verbal confirmation from a doctor that the dose is to be given. 36. Salbutamol 2.5mg nebulised when required for the relief of infusion related reactions Days 8, 15, 22 37. Blinatumomab 28micrograms/day by continuous intravenous infusion in 240ml sodium chloride 0.9% at a rate of 2.5ml/hour for 72 hours via a pump Administration Instructions Central venous access is required. Infuse through a dedicated lumen. Blinatumomab should be administered as a continuous intravenous infusion delivered at a constant flow rate using a pump. All infusions will contain sufficient volume and drug for a 96 hour infusion, although they will be administered over alternate 72 and 96 hours. The bag will contain; - 9microgram/day – 41.25microgram in 275ml - 28microgram/day – 133.75microgram in 275ml ARIA has been set up to administer the first, third, fifth and seventh infusions of the same cycle over 72 hours. This means that treatment must start on a Monday, Tuesday or Friday. The pump will contain sufficient drug and volume for 96 hours and must be programmed to stop after 72 hours. The bag must then be discarded. The second, fourth, sixth and eighth infusion of each cycle will be administered over 96 hours. Ensure the pump is set to stop at the correct times. Do not flush the remaining volume left in the infusion line into the patient, as it will cause an inadvertent bolus of blinatumomab to be administered. The line must be replaced with every change of pump. Administer blinatumomab through a Polyolefin, PVC non-DEHP, or EVA intravenous infusion line with a low proteinbinding 0.2µm in-line filter. The administration period must not exceed more that 28 days in any given cycle. The day of administration may need to be adjusted on ARIA depending on the time of the start of the day one infusion 38. Chlorpheniramine 10mg intravenous when required for the relief of infusion related reactions 39. Hydrocortisone 100mg intravenous when required for the relief of infusion related reactions 40. Pethidine 25mg when required for the relief of rigors Administration Instructions. For the relief of rigors following a verbal confirmation from a doctor that the dose is to be given. 41. Salbutamol 2.5mg nebulised when required for the relief of infusion related reactions Version 1 (July 2017) Page 12 of 14 ALL-Blinatumomab (3, 4 day schedule) Cycle 2, 3, 4, 5 Days 4, 11, 18, 25 42. Blinatumomab 28micrograms/day by continuous intravenous infusion in 240ml sodium chloride 0.9% at a rate of 2.5ml/hour for 96 hours via a pump Administration Instructions Central venous access is required. Infuse through a dedicated lumen. Blinatumomab should be administered as a continuous intravenous infusion delivered at a constant flow rate using a pump. All infusions will contain sufficient volume and drug for a 96 hour infusion, although they will be administered over alternate 72 and 96 hours. The bag will contain; - 9microgram/day – 41.25microgram in 275ml - 28microgram/day – 133.75microgram in 275ml ARIA has been set up to administer the first, third, fifth and seventh infusions of the same cycle over 72 hours. This means that treatment must start on a Monday, Tuesday or Friday. The pump will contain sufficient drug and volume for 96 hours and must be programmed to stop after 72 hours. The bag must then be discarded. The second, fourth, sixth and eighth infusion of each cycle will be administered over 96 hours. Ensure the pump is set to stop at the correct times. Do not flush the remaining volume in the infusion line into the patient, as it will cause an inadvertent bolus of blinatumomab to be administered. The line must be replaced with every change of pump. Administer blinatumomab through a Polyolefin, PVC non-DEHP, or EVA intravenous infusion line with a low proteinbinding 0.2µm in-line filter. The administration period must not exceed more that 28 days in any given cycle. The day of administration may need to be adjusted on ARIA depending on the time of the start of the day one infusion 43. Chlorpheniramine 10mg intravenous when required for the relief of infusion related reactions 44. Hydrocortisone 100mg intravenous when required for the relief of infusion related reactions 45. Pethidine 25mg when required for the relief of rigors Administration Instructions For the relief of rigors following a verbal confirmation from a doctor that the dose is to be given. 46. Salbutamol 2.5mg nebulised when required for the relief of infusion related reactions Take Home Medicines (day 1 only) 47. Paracetamol 1000mg four times a day for days 1 and 2 of the cycle then 1000mg four times a day as required 48. Aciclovir 400mg twice a day for 42 days oral 49. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday only for 42 days 50. Fluconaole 50mg once a day for 42 days oral Version 1 (July 2017) Page 13 of 14 ALL-Blinatumomab (3, 4 day schedule) DOCUMENT CONTROL Version Date Amendment Written By Approved By 1 July 2017 None Stuart Martin Pharmacist Dr Deborah Wright Pharmacist Dr Christopher Dalley Consultant Haematologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors that occur as a result of following these guidelines. Version 1 (July 2017) Page 14 of 14 ALL-Blinatumomab (3, 4 day schedule)
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/ALL/Blinatumomab.pdf

Papers Trust Board - 10 March 2026

Description: Date Time Location Chair Apologies Agenda Trust Board – Open Session 10/03/2026 9:00 - 13:00 Conference Room, Heartbeat Education Centre Jenni Douglas-Todd Steve Peacock 1 Chair’s Welcome, Apologies and Declarations of Interest 9:00 Note apologies for absence, and to hear any declarations of interest relating to any item on the Agenda. 2 Patient Story The patient story provides an opportunity for the Board to reflect on the experiences of patients and staff within the Trust and understand what the Trust could do better. 3 Minutes of Previous Meeting held on 13 January 2026 9:15 Approve the minutes of the previous meeting held on 13 January 2026 4 Matters Arising and Summary of Agreed Actions To discuss any matters arising from the minutes, and to agree on the status of any actions assigned at the previous meeting. 5 QUALITY, PERFORMANCE and FINANCE Quality includes: clinical effectiveness, patient safety, and patient experience 5.1 Briefing from the Chair of the Audit and Risk Committee 9:20 Ian Howard, Chief Financial Officer, for Chair 5.2 Briefing from the Chair of the Finance, Investment & Cash Committee 9:25 David Liverseidge, Chair 5.3 Briefing from the Chair of the People and Organisational Development 9:30 Committee Jane Harwood, Chair 5.4 Briefing from the Chair of the Quality Committee 9:35 including Interim Maternity and Neonatal Safety Report Tim Peachey, Chair 5.5 Chief Executive Officer's Report 9:40 Receive and note the report Sponsor: David French, Chief Executive Officer 5.6 Performance KPI Report for Month 10 10:10 Review and discuss the report Sponsor: Andy Hyett, Chief Operating Officer 5.7 Break 10:40 5.8 Finance Report for Month 10 10:55 Review and discuss the report Sponsor: Ian Howard, Chief Financial Officer 5.9 ICB System Report for Month 10 11:05 Receive and discuss the report Sponsor: Ian Howard, Chief Financial Officer 5.10 People Report for Month 10 11:10 Review and discuss the report Sponsor: Steve Harris, Chief People Officer 5.11 Freedom to Speak Up Report 11:20 Review and discuss the report Sponsor: Natasha Watts, Acting Chief Nursing Officer Attendee: Christine Mbabazi, Equality & Inclusion Adviser/Freedom to Speak Up Guardian 5.12 11:35 Guardian of Safe Working Hours Quarterly Report and Update on 10-Point Plan Review and discuss the report and update Sponsor: Paul Grundy, Chief Medical Officer Attendee: Diana Hulbert, Guardian of Safe Working Hours and Emergency Department Consultant 6 STRATEGY and BUSINESS PLANNING 6.1 Corporate Objectives 2025-26 Quarter 3 Update 11:50 Review and feedback on the corporate objectives Sponsor: David French, Chief Executive Officer Attendee: Martin de Sousa, Director of Strategy and Partnerships 6.2 Board Assurance Framework (BAF) Update 12:00 Review and discuss the update Sponsor: Natasha Watts, Acting Chief Nursing Officer Attendee: Craig Machell, Associate Director of Corporate Affairs and Company Secretary 7 CORPORATE GOVERNANCE, RISK and INTERNAL CONTROL 7.1 Feedback from the Council of Governors' (CoG) Meeting 29 January 2026 12:15 (Oral) Sponsor: Jenni Douglas-Todd, Trust Chair Page 2 7.2 Register of Seals and Chair's Actions Report 12:20 Receive and ratify the report In compliance with the Trust Standing Orders, Financial Instructions, and the Scheme of Reservation and Delegation. Sponsor: Jenni Douglas-Todd, Trust Chair 7.3 Audit and Risk Committee Terms of Reference 12:25 Review and approve the Terms of Reference Sponsor: Ian Howard, Chief Financial Officer, for Committee Chair Attendee: Craig Machell, Associate Director of Corporate Affairs and Company Secretary 7.4 Quality Committee Terms of Reference 12:30 Review and approve the Terms of Reference Sponsor: Tim Peachey, Committee Chair Attendee: Craig Machell, Associate Director of Corporate Affairs and Company Secretary 7.5 Remuneration and Appointment Committee Terms of Reference 12:35 Review and approve the Terms of Reference Sponsor: Jenni Douglas-Todd, Trust Chair Attendee: Craig Machell, Associate Director of Corporate Affairs and Company Secretary 8 Any other business 12:40 Raise any relevant or urgent matters that are not on the agenda 9 Note the date of the next meeting: 14 May 2026 10 Items circulated to the Board for reading 10.1 South Central Regional Research Delivery Network (SC RRDN) 2025-26 Q3 Performance Report Note the report Sponsor: Paul Grundy, Chief Medical Officer 11 Resolution regarding the Press, Public and Others Sponsor: Jenni Douglas-Todd, Trust Chair To agree, as permitted by the National Health Service Act 2006 (as amended), the Trust's Constitution and the Standing Orders of the Board of Directors, that representatives of the press, members of the public and others not invited to attend to the next part of the meeting be excluded due to the confidential nature of the business to be transacted. 12 Follow-up discussion with governors 12:45 Page 3 Agenda links to the Board Assurance Framework (BAF) 10 March 2026 – Open Session Overview of the BAF Risk 1a: Lack of capacity to appropriately respond to emergency demand, manage the increasing waiting lists for elective demand, and provide timely diagnostics, that results in avoidable harm to patients. 1b: Due to the current challenges, we fail to provide patients and their families / carers with a high-quality experience of care and positive patient outcomes. 1c: We do not effectively plan for and implement infection prevention and control measures that reduce the number of hospital-acquired infections and limit the number of nosocomial outbreaks of infection. 2a: We do not take full advantage of our position as a leading University teaching hospital with a growing, reputable, and innovative research and development portfolio, attracting the best staff and efficiently delivering the best possible treatments and care for our patients. 3a: We are unable to meet current and planned service requirements due to the unavailability of staff to fulfil key roles. 3b: We fail to develop a diverse, compassionate, and inclusive workforce, providing a more positive staff experience for all staff. 3c: We fail to create a sustainable and innovative education and development response to meet the current and future workforce needs identified in the Trust’s longer-term workforce plan. 4a: We do not implement effective models to deliver integrated and networked care, resulting in sub-optimal patient experience and outcomes, increased numbers of admissions and increases in patients’ length of stay. 5a: We are unable to deliver a financial breakeven position, resulting in: inability to move out of the NHS England Recovery Support Programme, NHS England imposing additional controls/undertakings, and a reducing cash balance impacting the Trust’s ability to invest in line with its capital plan, estates/digital strategies, and in transformation initiatives. 5b: We do not adequately maintain, improve and develop our estate to deliver our clinical services and increase capacity. 5c: Our digital technology or infrastructure fails to the extent that it impacts our ability to deliver care effectively and safely within the organisation, 5d: We fail to prioritise green initiatives to deliver a trajectory that will reduce our direct and indirect carbon footprint by 80% by 2028-2032 (compared with a 1990 baseline) and reach net zero direct carbon emissions by 2040 and net zero indirect carbon emissions by 2045. Agenda links to the BAF No Item Linked BAF risk(s) 5.6 Performance KPI Report for Month 10 5.8 Finance Report for Month 10 5.9 ICB System Report for Month 10 5.10 People Report for Month 10 5.11 Freedom to Speak Up Report 5.12 Guardian of Safe Working Hours Quarterly Report and Update on 10-Point Plan 1a, 1b, 1c 5a 5a 3a, 3b, 3c 3b 3b Appetite (Category) Minimal (Safety) Current risk rating 4x5 20 Cautious (Experience) Minimal (Safety) 4x4 16 4x4 16 Open (Technology & Innovation) 3x4 12 Open (workforce) Open (workforce) Open (workforce) 4x5 20 4x3 12 4x4 16 Cautious (Effectiveness) 3x3 9 Cautious (Finance) 5x5 25 Target risk rating 4 x 2 Apr 6 27 3 x 2 Apr 6 27 2 x 3 Apr 6 27 3 x 2 Mar 6 27 4 x 3 Mar 12 30 4 x 2 Mar 8 30 3 x 2 Mar 6 29 3 x 2 Dec 6 25 3 x 3 Apr 9 30 Cautious (Effectiveness) Open (Technology & Innovation) Open (Technology & Innovation) 4x5 20 4x4 16 2x4 8 4 x 2 Apr 8 30 3 x 2 Apr 6 27 2 x 2 Dec 4 27 Does this item facilitate movement towards or away from the intended target risk score and appetite? Towards Away Neither x x x x x x Minutes Trust Board – Open Session Date Time Location Chair 13/01/2026 9:00 – 13:00 Conference Room, Heartbeat Education Centre Jenni Douglas-Todd (JD-T) Present Jenni Douglas-Todd, Chair (JD-T) Keith Evans, Non-Executive Director (NED) (KE) David French, Chief Executive Officer (DAF) Paul Grundy, Chief Medical Officer (PG) Steve Harris, Chief People Officer (SH) Jane Harwood, NED/Senior Independent Director and Deputy Chair (JH) Ian Howard, Chief Financial Officer (IH) Andy Hyett, Chief Operating Officer (AH) David Liverseidge, NED (DL) Tim Peachey, NED (TP) Alison Tattersall, NED (AT) Natasha Watts, Acting Chief Nursing Officer (NW) In attendance Craig Machell, Associate Director of Corporate Affairs and Company Secretary (CM) James Allen, Chief Pharmacist (JA) (item 5.12) Julie Brooks, Deputy Director of Infection Prevention and Control (JB) (item 5.11) Blue Cunningham, Patient Engagement & Involvement Officer (item 2) John Mcgonigle, Emergency Planning & Resilience Manager (JMc) (item 6.1) Jenny Milner, Associate Director of Patient Experience (JM) (item 5.10) Julian Sutton, Clinical Lead, Department of Infection (JS) (item 5.11) 4 governors (observing) 5 members of staff (observing) 2 members of the public (observing) Apologies Diana Eccles, NED (DE) 1. Chair’s Welcome, Apologies and Declarations of Interest The Chair welcomed attendees to the meeting. There were no interests to declare in the business to be transacted at the meeting. It was noted that apologies had been received from Diana Eccles. The Chair provided an overview of meetings she had held and events that she had attended since the previous Board meeting. 2. Patient Story Blue Cunningham was invited to present the Patient Story on behalf of Jade […], whose nine-year-old daughter, Lucy, had had a bowel resection at the Trust. It was noted that: • Lucy was a very structured child, who relied heavily on planning and knowing outcomes as well as having sensitivities to lots of different sensory inputs. Page 1 • In their treatment of Lucy, staff paid particular attention to Lucy’s needs and adapted their behaviour and took the time to make Lucy’s stay in hospital as comfortable as possible. • This Patient Story clearly demonstrated the Trusts’ values and the time taken in the handling of Lucy by staff likely saved time and effort in the long run by not distressing the patient and then having to manage this situation. 3. Minutes of the Previous Meeting held on 11 November 2025 The draft minutes tabled to the meeting were agreed to be an accurate record of the meeting held on 11 November 2025, subject to reassigning action 1296 to James Allen. 4. Matters Arising and Summary of Agreed Actions The matters arising and actions were noted. • Action 1293: work had commenced on a broader MRI strategy. This work would be presented to the Quality Committee in due course – the action remained open. • Action 1294: this formed part of a larger piece of work, which would be addressed through the planning cycle. The action could be closed. • Action 1295: a solution had been developed, but the Trust was waiting on a third party to be able to implement the solution. The action could be closed. • Action 1296 was addressed as part of item 5.12 below. It was explained that the metric was based on day cases and national statistics and was intended to show usage levels of the most critical antibiotics. 5. QUALITY, PERFORMANCE and FINANCE 5.1 Briefing from the Chair of the Finance, Investment & Cash Committee David Liverseidge was invited to present the Committee Chair’s Reports in respect of the meetings held on 24 November and 15 December 2025, the contents of which were noted. It was further noted that: • The Trust had reported an in-month deficit of c.£5m and, at the end of November 2025, had reported a year-to-date deficit of £40m. • The committee had received an update in respect of the Trust’s theatres improvement plans, noting that there had been a 3% increase in utilisation and a 3% reduction in cancellations. • The committee had received a report on the Trust’s productivity based on the national framework and noted that further work was required to understand the metrics behind the national framework. • The committee had reviewed the Trust’s cash position and supported a proposal to request further cash support for January 2026. • The committee noted that whilst the Trust’s transformation plans were ambitious, they were nonetheless grounded in reality. • In its review of the proposed capital plans for 2026/27-2029/30, the committee noted the challenge of having to balance the Trust’s allocation of Capital Departmental Expenditure Limit (CDEL) with the cash available to the Trust. • The committee reviewed the Trust’s medium-term plan ahead of the first submission to NHS England on 17 December 2025. It was noted that the assumed reductions in patients with no criteria to reside and mental health Page 2 patients were those reasonably considered to be within the Trust’s control rather than reductions which were dependent on third parties. • The committee supported a proposal for transforming the Southern Counties Pathology network. 5.2 Briefing from the Chair of the People and Organisational Development Committee Jane Harwood was invited to present the Committee Chair’s Reports in respect of the meetings held on 21 November and 15 December 2025, the contents of which were noted. It was further noted that: • Whilst there had been reductions in the size of the substantive workforce, this had been offset by an increase in temporary staff due to a combination of demand, sickness absence, patients with no criteria to reside, and mental health patients. • The committee noted changes with respect to statutory and mandatory training, which would facilitate ‘passporting’ between NHS organisations. • The committee received an update in respect of the Trust’s Inclusion and Belonging strategy, noting that progress had been slower than anticipated due to available resource. It was further noted that the external political environment had also created additional challenges in this area. • The committee received an update regarding the Trust’s refreshed approach to violence and aggression, noting a greater willingness to take action against violent/abusive patients and members of the public. It was further noted that the communications accompanying the new approach would be key. • The committee reviewed the Trust’s performance against the ten-point plan for resident doctors, noting that the Trust was, subject to a few exceptions, in a good position. • Whilst the results of the Staff Survey were still under an embargo, early indications were that the participation rate was lower than hoped for. • The Trust’s seasonal vaccination campaign had been successful with over 50% of staff having been vaccinated against influenza. 5.3 Briefing from the Chair of the Quality Committee Tim Peachey was invited to present the Committee Chair’s Report in respect of the meeting held on 24 November 2025, the content of which was noted. It was further noted that: • The committee noted that the Trust’s Complaints service, particularly Patient Advice and Liaison Service (PALS), was fragile. There was a backlog of c.500 emails due to resource constraints. • The committee noted that despite the financial pressure the Trust was under, it had sought to maintain staff numbers to ensure patient safety. A significant proportion of the reduction in staff during the year had been from administrative staffing groups. Whilst the Trust had successfully reduced the size of the clinical administrative workforce, it had not been possible to transform how this service was delivered through technical or other means. Therefore, there was a risk of bottlenecks due to insufficient administrative staff with the high level of demand falling on a smaller number of staff. • NHS England had launched changes to maternity care reporting with additional reporting requirements with the aim of developing national standards and approaches. • The committee had reviewed the Trust’s Maternity and Neonatal Safety report for the second quarter and noted that the Trust had demonstrated compliance with the requirements for the NHS Resolution Maternity Incentive Scheme. Page 3 5.4 Chief Executive Officer’s Report David French was invited to present the Chief Executive Officer’s Report, the content of which was noted. It was further noted that: • NHS England had published latest segmentation and league tables under the NHS Oversight Framework for Quarter 2. The Trust had fallen slightly from 48 out of 134 to 51 out of 134. The Trust remained in segment 5 due to being in the Recovery Support Programme. • The number of patients waiting over 65 weeks in October 2025 had resulted in the Trust entering Tier 1 for elective performance. However, since that time, the Trust had successfully reduced the number of patients waiting over 65 weeks to c.80, with a target to reduce this number to nil by the end of March 2026. • The Employment Rights Bill received Royal Assent on 18 December 2025. The Act included a number of changes which would impact the Trust. These changes were to be reviewed in detail by the People and Organisational Development Committee. • During further strike action by resident doctors between 17 December and 22 December 2025, the Trust had met the national target of maintaining 95% of activity. Roughly one-third of resident doctors had taken part in the industrial action, which compared favourably to other trusts – some had reported a participation rate of 80-90%. • University Hospitals Sussex NHS Foundation Trust had been fined in connection with the death of a patient with severe mental health problems who had absconded from a ward at the trust and subsequently committed suicide. This case was pertinent for the Trust given the number of mental health patients currently being cared for at the Trust in the absence of a more appropriate setting. It was noted that the Trust’s policy was clear on the approach to be taken in the event of a similar situation to that faced by University Hospitals Sussex NHS FT. • On 2 January 2026, the Trust had been informed that its endoscopy service had had its accreditation renewed until 1 November 2026 following an annual review by the Royal College of Physicians’ Joint Advisory Group on Gastro- Intestinal Endoscopy. • Alison Tattersall had been appointed as the Trust’s second Nominated Trustee on the board of the Southampton Hospitals Charity. • The Trust’s department of clinical law – a service established to deal with clinical questions relating to regulatory and legal principles within the Trust – had been in existence for 16 years. 5.5 Performance KPI Report for Month 8 Andy Hyett was invited to present the ‘spotlight’ report in respect of Cancer waiting time targets, the content of which was noted. It was further noted that: • There had been an increase in referrals over recent years, but despite this increase, the Trust had maintained performance, particularly in respect of the 28-day faster diagnosis pathway. • Consideration was being given in terms of demographic groups to be targeted in view of the success of the Targeted Lung Health Check programme and its efforts to target particular sections of the population. • The main challenge in terms of improving performance was in terms of diagnostic capacity, including access to magnetic resonance imaging (MRI) and other imaging services. Improving the diagnostics services remained a key priority, including development of a longer-term strategy for imaging. It was noted that MRI and computed tomography (CT) scan capacity in the UK was lower than that in comparable nations such as those in the US and EU. Page 4 • The Trust maintained a good relationship with the Wessex Cancer Alliance, which was an effective route for obtaining additional funding for cancer care. Action Andy Hyett agreed to provide Jane Harwood with further data regarding the stage at which cancer was diagnosed by socio-economic group. Andy Hyett was invited to present the Performance KPI Report for Month 8, the content of which was noted. It was further noted that: • The Trust’s overall Referral To Treatment (RTT) waiting list for November 2025 had decreased by 0.9% and the Trust had made significant progress in reducing the number of patients waiting more than 65 weeks. • The number of patients waiting for diagnostics marginally increased, but the Trust had maintained its previous performance with c.80% of patients waiting under six weeks for the fourth month in a row. • The Trust’s performance against the four-hour emergency department target had improved by 5.8% since October 2025, achieving 60.4% in November 2025, which was above its in-year performance plan submitted at the beginning of 2025/26. The Board discussed the Performance KPI Report for Month 8. This discussion is summarised below: • In terms of the Trust’s RTT waiting list, it was forecast that there would be c.60,000 patients on this list by the end of March 2026 with performance against the 18-week target expected to be c.67%. • The Trust’s performance in respect of the number of mental health patients spending over 12 hours in accident and emergency was considered to be reflective of the need to admit mental health patients where there was no more appropriate venue available. This situation also gave rise to increased use of agency staff. A workshop had been held with Hampshire and Isle of Wight Healthcare NHS Foundation Trust (HIOWH) and an action plan had been agreed. It was noted that HIOWH was also experiencing challenges in terms of its ability to discharge patients. • The reduction in the percentage of virtual appointments as a proportion of all outpatient consultations compared to 2024/25 was being looked at. • As of 13 January 2026, there were 295 patients with no criteria to reside – equivalent to 12 wards – at Southampton General Hospital. Work was ongoing to create wards specifically for this cohort of patients. It was noted that Hampshire and Isle of Wight Integrated Care System was ranked 39 out of 42 in terms of its number of patients with no criteria to reside. 5.6 Break 5.7 Finance Report for Month 8 Ian Howard was invited to present the Finance Report for Month 8, the content of which was noted. It was further noted that: • The Trust had reported a £4.9m deficit for Month 8 (£40.8m deficit, year-to- date), which was in line with its Financial Recovery Plan. This in-month deficit had also been maintained for Month 9, with the year-to-date deficit increasing to £45.6m. • The Trust’s underlying deficit remained at c.£6m per month with continued high numbers of patients with no criteria to reside and mental health patients coupled with operational pressures. Page 5 • The Trust had carried out between £20m and £30m of unfunded work during the year and had incurred £10m-15m of costs associated with patients with no criteria to reside and mental health patients. • The Trust expected to deliver £90m of savings under its Cost Improvement Programme against its target of £110m. • The Trust had requested £8.4m of additional cash support for January 2026 and expected to require a further £3m of support in March 2026. 5.8 ICS System Report for Month 8 Ian Howard was invited to present the ICS System Report for Month 8, the content of which was noted. It was further noted that: • The Hampshire and Isle of Wight Integrated Care System had reported a year- to-date deficit of £65m, which represented a variance of £36m from plan. It was noted that the Trust was a significant contributor to this variance, but that other organisations were also now reporting variances to plan. • The Trust had achieved the best ambulance handover time performance in the system, but further work was ongoing across the system with South Central Ambulance Service (SCAS) to improve performance. 5.9 People Report for Month 8 Steve Harris was invited to present the People Report for Month 8, the content of which was noted. It was further noted that: • The overall workforce fell marginally during November 2025, with reduction in substantive staff of 52 whole-time-equivalents (WTE) being partially offset by an increase in temporary staff usage due to operational pressures and sickness absence. • The Trust remained above its 2025/26 plan by 214 WTE despite a decrease of nearly 400 WTE since 31 March 2025. In order to meet its Financial Recovery Plan, the Trust’s workforce needed to reduce by a further 137 WTE. • Sickness absence continued to increase with 4.2% being reported during November and 4.8% being reported for December 2025. • The 2025 Staff Survey had closed. It was noted that the results were expected to be challenging. • The Trust had hit its target of 58% of staff having been vaccinated against flu, which placed the Trust in the top 15 nationally and second in the South East. • There was a significant amount of work ongoing to refresh the Trust’s approach and policies in respect of violence and aggression, including policy changes, training and communications. 5.10 Learning from Deaths 2025-26 Quarter 2 Report Jenny Milner was invited to present the Learning from Deaths report for the second quarter, the content of which was noted. It was further noted that: • The Trust continued to benchmark well against other organisations. It was one of only 11 trusts nationally with a lower than anticipated mortality rate based on its summary hospital-level mortality indicator (SHMI) score. • The Medical Examiner Service had reviewed a total of 1,078 deaths, of which 36% had occurred at the Trust’s sites. • Patients with learning disabilities remained an area of concern, although progress was being made in this area. The Trust was one of only a few Page 6 organisations to hold separate meetings to discuss deaths of patients with learning disabilities. • The Trust had procured a system to support organisation-wide learning from Morbidity and Mortality outcomes. 5.11 Infection Prevention and Control 2025-26 Quarter 2 Report Julian Sutton and Julie Brooks were invited to present the Infection Prevention and Control report for the second quarter, the content of which was noted. It was further noted that: • For the period covered by the report (July-September 2025), the Trust had exceeded all measures in terms of the annual limits for incidences of bacteraemia. The Trust was in a similar position to other organisations nationally. • There had been two cases of Methicillin-resistant Staphylococcus aureus (MRSA) and 34 cases of Clostridioides difficile (C-diff) during the period. • There had been a focus on invasive device care management (such as cannulas and catheters) and on hand hygiene. • The Trust had successfully managed the Candidozyma auris outbreak, with only three new cases identified since the beginning of 2025, the last of which was identified in April 2025. 5.12 Medicines Management Annual Report 2024-25 James Allen was invited to present the Medicines Management Annual Report 2024/25, the content of which was noted. It was further noted that: • The Trust’s expenditure on medicines during 2024/25 was £215m, a 2% reduction compared to 2023/24 and was on track to spend only £207m during 2025/26. These reductions indicated that the strategy of using less expensive generic and biosimilar medicines had been effective in reducing costs. • The number of approvals for clinical trials and research activity had continued to improve. • The Trust had completed work to decommission nitrous oxide manifolds, which was expected to reduce the Trust’s nitrous oxide emissions by 600,000 litres per year, equivalent to 354 tonnes of carbon dioxide emissions. • An area of focus was the deployment of digital systems. Action Ian Howard agreed to look at the level of savings achieved in terms of medicines costs and how costs of medicines were budgeted for. 5.13 Ward Staffing Nursing Establishment Review 2025 Natasha Watts was invited to present the Ward Staffing Nursing Establishment Review 2025, the content of which was noted. It was further noted that: • The report set out the results of the ward staffing review undertaken between July and October 2025. • There was a renewed national focus on safe staffing. • Overall, the Trust’s staffing establishments remain appropriate and within recommended guidelines. Page 7 • Continued high levels of enhanced care demand, a significantly more junior workforce, managing additional surge areas, and the impact of financial controls had been highlighted as ongoing challenges. 6. CORPORATE GOVERNANCE, RISK and INTERNAL CONTROL 6.1 Annual Assurance for the NHS England Core Standards for Emergency Preparedness, Resilience and Response (EPRR) Jon Mcgonigle was invited to present the Annual Assurance for the NHS England Core Standards for Emergency Preparedness, Resilience and Response, the content of which was noted. It was further noted that: • NHS England required all trusts to complete an annual self-assessment against a number of core standards. In its assessment against 62 applicable core standards, the Trust was fully compliant with 56 and not yet fully compliant with 6 standards. • Of the areas where the Trust was not yet fully compliant, these related primarily to governance maturity, exercising and testing, workforce training consistency, and assurance evidence, rather than the absence of emergency response arrangements. • Since an initial report had been submitted to the Trust Executive Committee in November 2025, the Trust had completed development and approval of the Business Continuity Management System, completed the consultation and adoption of Protective Security and Emergency Lockdown arrangements, and had commenced consultation and system engagement for Evacuation and Shelter. • Training was scheduled to take place between February and May 2026 for on- call staff in charge. It was intended to hold a tabletop exercise during 2027. • It was noted that it had been some time since the Trust had practised a major incident response with other partners. • The Trust was on schedule to embed the ‘protect’ duty under the Terrorism (Protection of Premises) Act 2025 by March 2027. Action John Mcgonigle agreed to look at scheduling a major incident response exercise with other partners involved. 7. Any other business It was noted that the Trust had declared a critical incident on 10/11 December 2025 due to an IT system failure. It was noted that this was Keith Evans’ final formal meeting, as his second threeyear term as a non-executive director was due to expire on 31 January 2026. The Board expressed its thanks to Keith Evans for his service and support. 8. Note the date of the next meeting: 10 March 2026 Page 8 9. Resolution regarding the Press, Public and Others Decision: The Board resolved that, as permitted by the National Health Service Act 2006 (as amended), the Trust’s Constitution and the Standing Orders of the board of directors, that representatives of the press, members of the public and others not invited to attend to the next part of the meeting be excluded due to the confidential nature of the business to be transacted. The meeting was adjourned. Page 9 List of action items Agenda item Assigned to Deadline Status Trust Board – Open Session 11/11/2025 - 5.6 Performance KPI Report for Month 6 1293. MRI scanners and imaging Hyett, Andy 10/03/2026 Pending Explanation action item Andy Hyett agreed to work on and present at either a future Board meeting or Trust Board Study Session the Trust’s longer-term strategy with respect to MRI scanners and imaging. TB 13/01/26: work had commenced on a broader MRI strategy. This work would be presented to the Quality Committee in due course – the action remained open. Trust Board – Open Session 09/09/2025 - 8 Any other business 1286. Organ donation Machell, Craig Explanation action item Craig Machell agreed to add organ donation to the agenda of a future Trust Board Study Session. 16/04/2026 Pending Update: Item deferred to TBSS on 16/04/26. Trust Board – Open Session 15/07/2025 - 5.11 Freedom to Speak Up Report 1267. Data Mbabazi, Christine 10/03/2026 Pending Explanation action item Christine Mbabazi to include data from other mechanisms for reporting concerns in future Freedom to Speak Up reports. Page 1 of 2 Agenda item Assigned to Deadline Status Trust Board – Open Session 13/01/2026 - 5.5 Performance KPI Report for Month 8 1311. Cancer diagnosis Hyett, Andy 10/03/2026 Pending Explanation action item Andy Hyett agreed to provide Jane Harwood with further data regarding the stage at which cancer was diagnosed by socio-economic group. Trust Board – Open Session 13/01/2026 - 5.12 Medicines Management Annual Report 2024-25 1312. Medicines costs Howard, Ian 10/03/2026 Pending Explanation action item Ian Howard agreed to look at the level of savings achieved in terms of medicines costs and how costs of medicines were budgeted for. Trust Board – Open Session 13/01/2026 - 6.1 Annual Assurance for the NHS England Core Standards for Emergency Preparedness, Resilience and Response (EPRR) 1313. Major incident response exercise Mcgonigle, John Hyett, Andy 10/03/2026 Pending Explanation action item John Mcgonigle agreed to look at scheduling a major incident response exercise with other partners involved. Page 2 of 2 Agenda Item 5.1 Committee Chair’s Report to the Trust Board of Directors 10 March 2026 Committee: Audit & Risk Committee Meeting Date: 27 January 2026 Key Messages: Assurance: (Reports/Papers reviewed by the Committee also appearing on the Board agenda) • The committee considered the accounting policies and management judgements in respect of the 2025/26 annual accounts, noting the impact of the review of the Modern Equivalent Asset valuation estimation methodology. This review was to ensure that the valuation reflects specialised assets based on a modern, functionally equivalent facility at an alternative location, rather than simply replicating the current buildings and equipment. • The committee received an update in respect of the work on the Trust’s interim accounts, noting that there had been significant improvements in terms of use and recording of manual adjustments, with an objective of further reducing the use of manual adjustments in future. • The committee noted the work undertaken to address the issues identified in the production of the 2023/24 and 2024/25 accounts. • The committee reviewed the Trust’s compliance with the Code of Governance for NHS Provider Trusts, noting that the Trust was compliant in all areas or had appropriate explanations for areas of non-compliance, of which there were only a few. • The committee received a report on compliance with the Trust’s Standards of Business Conduct Policy, noting that the level of declarations of interest had remained largely static and that further work would be required to review the Trust’s approach in this area. • The committee received updates in respect of the internal audit programme, including the reports in respect of an audit of cyber security and the Trust’s core financial systems. • An update was provided in respect of the work of the counter-fraud team. It was noted that the risk of temporary worker impersonation was a particular area of focus. In addition, the committee noted the work undertaken to review the Trust’s compliance with the Economic Crime and Corporate Transparency Act 2023. 6.2 Board Assurance Framework (BAF) Update Assurance Rating: Risk Rating: Substantial N/A • All risks had been reviewed with the relevant executive director(s). • There had been no significant changes in ratings or target dates since the BAF had been last reviewed in October 2025. However, the committee challenged how realistic some of the target dates were on the basis that many of the actions required were reliant on third parties. • The committee suggested that the rating for risk 5c should be reconsidered in view of the increasing cyber risk. • It was noted that the actions from the internal audit on the Trust’s risk management maturity were on track. Page 1 of 2 Any Other Matters: 7.4 Audit and Risk Committee Assurance Rating: Risk Rating: Terms of Reference Substantial N/A • The committee reviewed its Terms of Reference and no changes were proposed. • The committee recommended that the Board approve the revised Terms of Reference. N/A Assurance Rating: Substantial There is a robust series of suitably designed internal controls in place upon Assurance which the organisation relies to manage the risk of failure of the continuous and effective achievement of the objectives of the process, which at the time of our review were being consistently applied. Reasonable There is a series of controls in place, however there are potential risks that Assurance may not be sufficient to ensure that the individual objectives of the process are achieved in a continuous and effective manner. Improvements are required to enhance the adequacy and effectiveness of the controls to mitigate these risks. Limited Assurance Controls in place are not sufficient to ensure that the organisation can rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Significant improvements are required to improve the adequacy and effectiveness of the controls. No Assurance There is a fundamental breakdown or absence of core internal controls such that the organisation cannot rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Immediate action is required to improve the adequacy and effectiveness of controls. Not Applicable Where assurance is not required and/or relevant. Risk Rating: Low Medium High Not Applicable Based on the report considered by the committee, there is little or no concern that the Trust will be unable to meet its stated objectives and/or plans. There is some concern that the Trust might not be able to fully meet its stated objectives and/or plans based on the information contained in the report considered by the committee. There is a significant risk that the Trust will not be able to meet its stated objectives and/or plans based on the information contained in the report considered by the committee. Where risk rating is not relevant. Page 2 of 2 Agenda Item 5.2 i) Committee Chair’s Report to the Trust Board of Directors 10 March 2026 Committee: Finance, Investment and Cash Committee Meeting Date: 26 January 2026 Key Messages: Assurance: (Reports/Papers reviewed by the Committee also appearing on the Board agenda) • The committee received the Finance Report for Month 9. The Trust had reported an in-month deficit of £4.9m and continued to report in line with the Financial Recovery Plan. The Trust had also delivered £10.3m of savings under the Cost Improvement Programme during the month. The modern equivalent assets review had been completed, which delivered £3m of benefit during the month. • The committee carried out a deep-dive into the Trust’s underlying financial position, noting that there had been £15.8m of one-off adjustments and that the underlying deficit was £61.4m year-to-date. The monthly underlying deficit continued to be c.£6m and therefore the 2025/26 exit position was assessed to be £72m. • The committee received an update on the Trust’s medium term planning submission, noting that it was expected that the Trust would submit a non-compliant plan. There remained a significant gap between the level of performance required under the framework and the available funding and an absence of proposals from Specialised Commissioning. It was noted that the assumptions regarding noncriteria to reside numbers were based on factors within the Trust’s control, rather than those dependent on third parties. • The committee received an update on financial improvement, noting that the Trust was £4m behind its CIP plan for 2025/26, expecting to deliver £88m of savings by year end compared to the £110m target. The Trust was targeting £50m of CIP savings for 2026/27. Based on national data, the Trust had the tenth smallest opportunity for productivity savings. • The committee considered the Trust’s cash position as at 31 December 2025 and the forecast cash position for the remainder of the financial year. The Trust expected to require a further £2.9m of cash support in March 2026, which the committee supported. • The committee received an update in respect of the Trust’s outsourced cleaning and catering services contract. N/A Any Other N/A Matters: Assurance Rating: Substantial There is a robust series of suitably designed internal controls in place upon Assurance which the organisation relies to manage the risk of failure of the continuous and effective achievement of the objectives of the process, which at the time of our review were being consistently applied. Page 1 of 2 Reasonable Assurance Limited Assurance No Assurance Not Applicable There is a series of controls in place, however there are potential risks that may not be sufficient to ensure that the individual objectives of the process are achieved in a continuous and effective manner. Improvements are required to enhance the adequacy and effectiveness of the controls to mitigate these risks. Controls in place are not sufficient to ensure that the organisation can rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Significant improvements are required to improve the adequacy and effectiveness of the controls. There is a fundamental breakdown or absence of core internal controls such that the organisation cannot rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Immediate action is required to improve the adequacy and effectiveness of controls. Where assurance is not required and/or relevant. Risk Rating: Low Medium High Not Applicable Based on the report considered by the committee, there is little or no concern that the Trust will be unable to meet its stated objectives and/or plans. There is some concern that the Trust might not be able to fully meet its stated objectives and/or plans based on the information contained in the report considered by the committee. There is a significant risk that the Trust will not be able to meet its stated objectives and/or plans based on the information contained in the report considered by the committee. Where risk rating is not relevant. Page 2 of 2 Agenda Item 5.2 ii) Committee Chair’s Report to the Trust Board of Directors 10 March 2026 Committee: Finance, Investment and Cash Committee Meeting Date: 23 February 2026 Key Messages: • • • • • • • • • The committee received the Finance Report for Month 10 (see below). The committee received an update in respect of the impact of the fire at Southampton General Hospital on 1 February 2026, including in respect of the actions being taken to restore the lost services and the Trust’s claims under the NHS Resolution Property Expenses Scheme and under its commercial insurance policy. The committee received an update following the submission of the Trust’s medium term plan on 12 February 2026, noting that the Trust’s current proposed deficit made it an outlier. There remained a significant gap between the level of funding available from commissioners and the performance required under the framework. The committee enquired as to the possible route to resolve and supported the view that pricing of activity needed to be set at a level which did not create an increasing deficit as it currently does in critical care areas. Following the external review recommendations, the committee look forward to a deeper dive into the drivers of the increases in the Trust’s cost base over the past 5-6 years as this has increased at a greater rate than activity levels. This is planned for the March 2026 meeting. The committee received an update in respect of the Always Improving programme, noting that the fire had prompted something of a re-think in terms of organisational and system fundamentals. It was noted that there had been changes in the Trust’s risk appetite in terms of management of patients having no criteria to reside and outpatient appointments. Sustaining the improvements in these areas was considered to be a key priority. The committee received a report on the roll out of the MIYA system in the Trust’s emergency department, which went live on 8 October 2025. It was noted that whilst there had been some initial impact on performance during the first weeks, this had been expected, and the issues appeared to have been largely resolved. The system had delivered improvements in clinical management and in terms of data analytics. The committee noted that the Trust had been awarded £39m in capital funding for 2025/26. It was noted that this was a significant amount of funding to be used during the final months of 2025/26 and that work was ongoing to secure this funding through placing of orders and other activity. The committee received an update in respect of the Trust’s proposed tender for car parking services. The committee supported the proposals to obtain mobile endoscopy units to address the loss of the Trust’s endoscopy service in the fire on 1 February 2026. The committee noted proposals in respect of changes to NHS Property Services. Page 1 of 3 Assurance: (Reports/Papers reviewed by the Committee also appearing on the Board agenda) Any Other Matters: 5.8 Finance Report for Month 10 Assurance Rating: Risk Rating: Substantial High • The Trust had submitted a revised forecast to NHS England of a deficit of £49.9m following a request for an ‘art of the possible’ reforecast. The Trust had since received additional funding, which reduced the 2025/26 forecast deficit to c.£45m. • The Trust had reported a year-to-date deficit of £44.8m, with the underlying monthly deficit remaining between £5.5-6m. The Trust expected additional one-offs during the final months, but there was significant risk associated with this. • The Trust was forecasting CIP delivery of £94m for 2025/26, with £78m achieved year-to-date. • Whilst there had been some increase in workforce numbers in December 2025 and January 2026, it was considered normal for this to occur during this period, however this was creating a deviation from the planned workforce numbers. This was explained as the result of the decision taken to address 65- and 52-week waits which had therefore impacted staff numbers. The resulting increased income from additional work had yet to register in the Trust's revenue numbers but was expected in February and March.. 6.2 Board Assurance Framework (BAF) Update Assurance Rating: Risk Rating: N/A • Risk 5a remained the Trust’s highest-rated risk at 25 and the target date for reduction had been extended by six months due to continued uncertainty around the funding available during 2026/27 and the impact of the fire on 1 February 2026. • Risk 5b had been assessed following the fire, but it was considered that whilst there had been significant disruption, the event and subsequent activities had been well-managed and demonstrated the effectiveness of the Trust’s evacuation and business continuity plans. Accordingly, no changes were proposed to the rating. • There had been an increase in the rating of risk 5c, largely due to risks surrounding the age of the Trust’s digital infrastructure and uncertainty regarding the OneEPR programme. The committee reviewed the Trust’s cash position and forecast, and the committee supported the additional request to be submitted in February 2026 for cash support up to a maximum of £10m to be received in April 2026. The trajectory for cash support in 2026/27 was to be reviewed at the March 2026 meeting. Assurance Rating: Substantial There is a robust series of suitably designed internal controls in place upon Assurance which the organisation relies to manage the risk of failure of the continuous and effective achievement of the objectives of the process, which at the time of our review were being consistently applied. Reasonable There is a series of controls in place, however there are potential risks that Assurance may not be sufficient to ensure that the individual objectives of the process are achieved in a continuous and effective manner. Improvements are required to enhance the adequacy and effectiveness of the controls to mitigate these risks. Page 2 of 3 Limited Assurance No Assurance Not Applicable Controls in place are not sufficient to ensure that the organisation can rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Significant improvements are required to improve the adequacy and effectiveness of the controls. There is a fundamental breakdown or absence of core internal controls such that the organisation cannot rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Immediate action is required to improve the adequacy and effectiveness of controls. Where assurance is not required and/or relevant. Risk Rating: Low Medium High Not Applicable Based on the report considered by the committee, there is little or no concern that the Trust will be unable to meet its stated objectives and/or plans. There is some concern that the Trus
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BRC Research Theme Lead Designate JD and PS

Description: NIHR Southampton Biomedical Research Centre Research Theme Lead Designate National Institute for Health and Care Research (NIHR) Biomedical Research Centre (BRC) Research Theme Lead (2028-2033/35). The role is subject to the University Hospital Southampton (UHS) and the University of Southampton (UoS) partnership being awarded a BRC from 2028. The role holder will act as BRC Research Theme Lead Designate from appointment in 2026, leading the preparations for their theme and submission of the Southampton NIHR BRC 2028-2033/35 application. The designate role will formally start in January 2026 for a term of 27 months. If the current Research Theme Lead resigns before the end of the current BRC award, the designate will formally step into the theme lead role. JOB ROLE Role Title NIHR Southampton BRC Research Theme Lead Designate Accountable to NIHR Southampton BRC Director/Director Designate Hours / Duration It is anticipated that theme leadership duties will be acknowledged within job plans and should not exceed 2 PAs per week. There will be no direct remuneration for the role. Role holders will act as theme leads in the lead-up to the NIHR Southampton BRC 2028-2033/35 competition, and thereafter subject to the relevant theme being awarded as part of an overall successful application for a BRC starting in 2028, and the agreement of the UHS/UoS Partnership. BRC Themes: overall purpose Each theme will have an identified Theme Lead, who is at the forefront of their field, and optionally a co-theme lead. The Theme Lead must meet, or have a realistic prospect of meeting in the near future, any criteria set by the NIHR for BRC theme leads. The BRC Theme Lead is accountable to the BRC Director/Director Designate and BRC Board for the delivery of their scientific programme, as outlined in the NIHR BRC Application and approved by the JRSB and NIHR, taking into account the resources awarded by NIHR. Each theme will have specific aims and objectives as well as a research strategy. The Theme Lead will collaborate, integrate and promote scientific excellence in core BRC research platforms and affiliated projects led by University and/or Trust investigators. The Theme Lead will advise the BRC Board on the progress and key issues which may affect the delivery of their scientific Theme. Main Purpose: 1. To lead the development and delivery of the scientific programme of research in their designated theme, convening regular meetings of their team, PPIEP, research inclusion, industry, capacity and capability and other relevant leads and core research programme members. 2. Contribute to the overall strategic management of the BRC in conjunction with the BRC Director/Director Designate, collaborating and coordinating activities with other themes, ensuring regular attendance at the BRC Scientific and Management meetings and BRC Board meetings for this purpose. 3. To determine resources required to develop and deliver projects and research activities within their theme, ensuring budgets are realistic, provide value for money and are appropriately managed to ensure financial balance. To work with the BRC Senior Programme Manager to ensure necessary BRC co-funding requirement is secured. 4. Work with specific Research Leads across all research themes to ensure the effective design and delivery of research on time, to target and within budget. 5. Deliver growth within the research programme in line with NIHR expectations, increasing the volume of high-quality research (translational and experimental medicine, and proof of concept) delivered and associated patient recruitment, publications, impacts and external income. 6. Work with the named NIHR BRC Academic Career Development Lead and Capacity and Capability Project Manager to develop and deliver theme-specific capacity development plans. This will include individuals supported to complete post-graduate research training (DM and PhD), pre- and post-doctoral fellowship and internship programmes and other related training activities. 7. Maintain and develop an inclusive and supportive research culture engaging with patients and researchers as equal partners. 8. Work closely with the director of SCREI, named PPIE lead and EDI champions to ensure PPIE/EDI (research inclusion) is integral to all stages of the research life cycle. 9. Work closely with the innovation champion to ensure that industry engagement and partnership are integral to all stages of the research life cycle. 10. To ensure the theme’s research programme incorporates opportunities to engage relevant NIHR infrastructure elements, which include CRF, TRCs, ARC Wessex, NIHR BioResources, SCTU, SDE and others. Where relevant, link with other NIHR infrastructures that are theme-specific. 11. To engage with other participants in the translational pathway, in particular basic scientists within the UoS and implementation specialists within ARC Wessex. 12. To develop the theme’s research programme to incorporate opportunities to engage relevant academics from HEIs, NHS Trusts, public health, Wessex Health Partners, NIHR Wessex Experimental Medicine Network, ICBs, local authorities and the third sector where applicable including promoting cross-disciplinary collaboration. 13. Be responsible for the timely completion of periodic internal reports and annual plans in accordance with NIHR timescales for their respective theme and overarching the NIHR BRC annual report. 14. Identify the need for any significant changes to the theme strategy and seek approval from the NIHR BRC Board for any proposed changes. 15. Contribute to the integrated approach to research governance and management upholding standards of good governance within the BRC. 16. To lead on, or contribute, as appropriate, to the leadership of cross-BRC programmes of work in areas of thematic or research specialism (as the opportunity arises). To ensure their theme participates in BRC research themes and cross-cutting work programmes. 17. To contribute to the development and delivery of BRC external engagement strategy in order to enhance external understanding and appreciation of the BRC locally, regionally, nationally and globally. PERSON SPECIFICATION Criteria Essential Desirable Qualifications, knowledge and experience PhD or equivalent professional qualifications and experience in experimental medicine https://www.nihr.ac.uk/about-us/what-we-do/infrastructure Detailed knowledge of experimental medicine A significant regional or national reputation in experimental medicine A sustained record of excellence in teaching and learning activities in experimental medicine A sustained record of excellence in research activities as indicated through high-impact publications and citations in translational research. Proven ability to work with industry and other research institutes to generate external income. Experience in patient involvement/engagement activities related to experimental medicine. Proven ability to engage with community members, especially in underserved populations; understand local needs and support research initiatives. Membership of regional or national advisory bodies learned societies Involvement in national academies of science and organisations in scientific areas of relevance to the NIHR Southampton BRC Planning/Leadership and organising Proven ability to champion and oversee key contributions to translational research & in NHS and local settings. Proven ability to lead a programme of research activities. Proven leadership ability in University, NHS and other settings such as other NIHR infrastructures (CRF, ARC, TRCs) Problem solving and initiative Proven ability to implement successful change management initiatives and formulate strategic plans that reflect and support the priority needs of the BRC, NIHR, NHS, University, UHS/UoS clinical research partnership and other local stakeholders. Management and teamwork Proven ability to oversee people and resource management processes in order to deliver key research and implementation activities. Proven ability to demonstrate patient involvement/engagement are integral to research activities. Proven ability to make a sustained contribution to academic leadership at a senior level. Proven ability to demonstrate leadership abilities in multiple settings and to raise performance standards through own work areas. Proven ability to recognise and deal with obstacles and difficulties so that the team can deliver. Proven ability to mentor and support career development in others. Communicating and influencing Proven ability to establish and build major relationships with stakeholders. Proven ability to act as the main figurehead for key activities, developing important national and international contacts. Able to contribute to the development of the BRC and UHS/UoS partnerships profile in the UK and internationally. Proven ability to use influence to develop positions or strategies. Other skills and behaviours Compliance with relevant Health & Safety issues Positive attitude towards colleagues and students Special requirements Able to attend national and international conferences as required. JD – NIHR Southampton BRC Research Theme Lead V3.21/11/2025
Url: /Media/Southampton-Clinical-Research/Downloads/BRC-Research-Theme-Lead-Designate-JD-and-PS.docx

NIHR BRC Theme ACDL

Description: NIHR BRC Theme Academic Career Development Lead Call for Expressions of Interest The University Hospital Southampton NHS Foundation Trust (UHS) and University of Southampton (UoS) are inviting an Expression of Interest for the role of NIHR BRC Theme Academic Career Development Lead (ACDL). The NIHR Southampton Biomedical Research Centre takes new discoveries, treatments and technologies into the clinic, using unique tools, facilities and world-changing expertise across our five key research areas. We aim to improve people's health and resilience throughout life, generating the next generation of improved and personalised treatments. Our Theme ACDLs are responsible for supporting the development, delivery, monitoring and evaluation of the Academic Career Development Strategy. The strategy aims to attract, retain and develop individuals along the career pathway, from pre-doctoral scholar to senior research leader, supporting equity of opportunity, achieving a diverse workforce, and developing talented individuals from all relevant professional backgrounds (doctors, nurses, AHPs, pharmacists, scientists, infrastructure support staff). The BRC achieves this through strategic investment in talented people using open, transparent, competitive processes via mentoring programmes, leadership development programmes, and focussed learning based on an analysis of learning needs. The partnership seeks to appoint an individual to work with the BRC ACDL to deliver the strategy for the current BRC funding cycle (2022-2027). Specifically, we wish to appoint an individual employed by University Hospital Southampton NHSFT or University of Southampton who has an appreciation and passion for developing the research careers of research scientists, nurses, midwives, allied health professionals, healthcare scientists, pharmacists and doctors. It is anticipated that, alongside delivery of the BRC’s offer for relevant professional groups, the portfolio of responsibility for each ACDL will be negotiated in relation to specific Themes and project work relevant to their experience, ensuring there is parity of activity and responsibilities across the ACDL team. The Theme ACDL will be formally identified and recognised within their institution. The Theme ACDL will be named in any training materials, induction packs and other communication tools relevant to their engagement with individuals on an academic track. The successful candidate will have strong leadership and management skills and a track record of building experimental research capacity and capability. Expressions of interest should be made through submission of an up-to-date curriculum vitae (CV) and covering letter to brc-applications@uhs.nhs.uk. The covering letter should detail your reasons for applying and what you would bring to the role. The deadline for submissions of expressions of interest is 12:00 midday on Monday 26th May 2025. Expressions of interest will be shortlisted and interviews will be held on Friday 6th June 2025. See Appendix 1 for role description and person specification. For further information, please contact Associate Professor Malcolm West, the BRC Academic Career Development Lead at m.west@soton.ac.uk. Appendix 1 Southampton BRC Theme Academic Career Development Lead Role Description and Person Specification Job Role Role title: Southampton BRC Theme Academic Career Development Lead (ACDL) Time commitment: Up to 1 programmed activity or up to 0.1 WTE Role accountable to1: BRC Academic Career Development Lead BRC Director BRC Senior Programme Manager 1 Line management arrangements for the substantive post held by the individual will remain unchanged Posts works closely with: BRC Theme ACDLs, BRC Theme Leads, UHS R&D Director, UoS Associate Dean for Research Faculty of Medicine and Deputy Head of School (Research) School of Health Science, relevant UoS Graduate School Directors, other Southampton-aligned NIHR Academic Career Development Leads and Infrastructure Directors, BRC EDI Lead, Head of SCEI Background Reflecting our commitment to career development, the Southampton BRC has developed an academic career development team to help build the organisation’s leadership capacity and capability. This consists of tailored education, training and career development of our BRC research and infrastructure workforce, guided and overseen by the BRC Academic Career Development Lead. The Theme ACDLs form part of this team. Vision Our vision is to attract, retain and develop individuals along the career pathway, from pre-doctoral scholar to senior research leader, supporting equity of opportunity, achieving a diverse workforce, and developing talented individuals from all relevant professional backgrounds (doctors, nurses, AHPs, pharmacists, scientists, infrastructure support staff). Key primary responsibilities 1. Support Southampton BRC’s Academic Career Development Strategy and delivery plan in collaboration with the wider Academic Career Development team. 2. Undertake responsibility for specific Themes and project work (e.g. PhD Studentship programme), consulting with the BRC Academic Career Development Lead. 3. Be an active participant in NIHR Academy Academic Career Development Forum meetings. 4. Work with the wider Academic Career Development Forum and NIHR Academy to integrate local academic career development initiatives with national schemes and activities. 5. Share good academic career development practice and learn from others. 6. Support the timely collation of information on BRC-aligned NIHR Academy members and Associate members to be reported to NIHR, supported by the BRC administration team. 7. Communicate NIHR academic research opportunities to BRC-aligned NIHR Academy members. 8. Work with the Southampton Academy of Research making an active contribution to the UHS Pioneering Research and Innovation strategy. 9. Work closely with the UoS Faculty of Medicine Associate Dean for Research and School of Health Sciences Deputy Head of School (Research), the Director of the Southampton Clinical Academic Training Scheme (SoCATS) and other infrastructure Academic Career Development Leads and relevant Graduate School Directors to achieve coordinated activity across the Southampton partnership. 10. Actively engage with NIHR via the NIHR Academy and/or Research Council training initiatives and represent Southampton at NIHR national and regional training meetings. 11. Maintain and develop Southampton’s reputation as a leading centre for health research talent management. 12. Help support and develop the SoAR BRC early career researcher champions/Theme Links, as appropriate to agreed portfolio. 13. Together with the Academic Career Development Lead, advise the BRC on strategic direction for research training and education. Strategy will be developed in the context of NIHR Academy strategy and policy and the Trust and University strategic visions and operational structures. 14. Together with the Academic Career Development Lead, identify research training and education priorities, representing clinical academic staff/units engaged or wishing to engage in clinical academic career pathways in relation to translational research. 15. Deputise for the BRC Academic Career Development Lead at BRC Board meetings, Scientific and Management Committee meetings, and Operational Strategic Delivery Leads meetings as required. 16. Promote the BRC through public speaking, public engagement and networking. 17. Contribute to the integrated approach to research governance and management, upholding standards of research governance through facilitating training and education opportunities. Person specification Criteria – Qualifications, knowledge and experience Essential • PhD or equivalent professional qualifications and experience in translational research • Detailed knowledge of translational research • A sustained record of excellence in teaching and learning activities in translational research Desirable • Sustained record of capacity building in research through supervising, championing, supporting or mentoring individuals and/or programmes • Membership of national or international advisory bodies and/or learned societies. Involvement in national and international academies of science and organisations. Membership of national committees that manage fellowship schemes and training initiatives • Experience of career mentoring Criteria – Planning/leadership and organising Essential • Proven leadership ability in University, NHS or other settings Desirable • Qualification in leadership Criteria – Problem solving and initiative Essential • Proven ability to implement successful change management initiatives and formulate them in the context of career development/support Criteria – Management and teamwork Essential • Proven ability to oversee people and resource management processes in order to deliver key activities • Proven ability to recognise and deal with obstacles and difficulties so the team can deliver Criteria – Communicating and influencing Essential • Proven ability to establish and build relationships with multiple stakeholders • Able to contribute to the development of the UHS/UoS partnerships profile • Proven ability to use influence to develop positions or strategies Criteria – Other skills and behaviours Essential • Compliance with relevant Health & Safety issues • Positive attitude to colleagues and students Criteria – Special requirements Essential • Able to attend national meetings as required
Url: /Media/Southampton-Clinical-Research/Downloads/NIHR-BRC-Theme-ACDL.pdf

NIHR BRC Theme ACDL

Description: NIHR BRC Theme Academic Career Development Lead Call for Expressions of Interest The University Hospital Southampton NHS Foundation Trust (UHS) and University of Southampton (UoS) are inviting an Expression of Interest for the role of NIHR BRC Theme Academic Career Development Lead (ACDL). The NIHR Southampton Biomedical Research Centre takes new discoveries, treatments and technologies into the clinic, using unique tools, facilities and world-changing expertise across our five key research areas. We aim to improve people's health and resilience throughout life, generating the next generation of improved and personalised treatments. Our Theme ACDLs are responsible for supporting the development, delivery, monitoring and evaluation of the Academic Career Development Strategy. The strategy aims to attract, retain and develop individuals along the career pathway, from pre-doctoral scholar to senior research leader, supporting equity of opportunity, achieving a diverse workforce, and developing talented individuals from all relevant professional backgrounds (doctors, nurses, AHPs, pharmacists, scientists, infrastructure support staff). The BRC achieves this through strategic investment in talented people using open, transparent, competitive processes via mentoring programmes, leadership development programmes, and focussed learning based on an analysis of learning needs. The partnership seeks to appoint an individual to work with the BRC ACDL to deliver the strategy for the current BRC funding cycle (2022-2027). Specifically, we wish to appoint an individual employed by University Hospital Southampton NHSFT or University of Southampton who has an appreciation and passion for developing the research careers of research scientists, nurses, midwives, allied health professionals, healthcare scientists, pharmacists and doctors. It is anticipated that, alongside delivery of the BRC’s offer for relevant professional groups, the portfolio of responsibility for each ACDL will be negotiated in relation to specific Themes and project work relevant to their experience, ensuring there is parity of activity and responsibilities across the ACDL team. The Theme ACDL will be formally identified and recognised within their institution. The Theme ACDL will be named in any training materials, induction packs and other communication tools relevant to their engagement with individuals on an academic track. The successful candidate will have strong leadership and management skills and a track record of building experimental research capacity and capability. Expressions of interest should be made through submission of an up-to-date curriculum vitae (CV) and covering letter to brc-applications@uhs.nhs.uk. The covering letter should detail your reasons for applying and what you would bring to the role. The deadline for submissions of expressions of interest is 12:00 midday on Monday 26th May 2025. Expressions of interest will be shortlisted and interviews will be held on Friday 6th June 2025. See Appendix 1 for role description and person specification. For further information, please contact Associate Professor Malcolm West, the BRC Academic Career Development Lead at m.west@soton.ac.uk. Appendix 1 Southampton BRC Theme Academic Career Development Lead Role Description and Person Specification Job Role Role title: Southampton BRC Theme Academic Career Development Lead (ACDL) Time commitment: Up to 1 programmed activity or up to 0.1 WTE Role accountable to1: BRC Academic Career Development Lead BRC Director BRC Senior Programme Manager 1 Line management arrangements for the substantive post held by the individual will remain unchanged Posts works closely with: BRC Theme ACDLs, BRC Theme Leads, UHS R&D Director, UoS Associate Dean for Research Faculty of Medicine and Deputy Head of School (Research) School of Health Science, relevant UoS Graduate School Directors, other Southampton-aligned NIHR Academic Career Development Leads and Infrastructure Directors, BRC EDI Lead, Head of SCEI Background Reflecting our commitment to career development, the Southampton BRC has developed an academic career development team to help build the organisation’s leadership capacity and capability. This consists of tailored education, training and career development of our BRC research and infrastructure workforce, guided and overseen by the BRC Academic Career Development Lead. The Theme ACDLs form part of this team. Vision Our vision is to attract, retain and develop individuals along the career pathway, from pre-doctoral scholar to senior research leader, supporting equity of opportunity, achieving a diverse workforce, and developing talented individuals from all relevant professional backgrounds (doctors, nurses, AHPs, pharmacists, scientists, infrastructure support staff). Key primary responsibilities 1. Support Southampton BRC’s Academic Career Development Strategy and delivery plan in collaboration with the wider Academic Career Development team. 2. Undertake responsibility for specific Themes and project work (e.g. PhD Studentship programme), consulting with the BRC Academic Career Development Lead. 3. Be an active participant in NIHR Academy Academic Career Development Forum meetings. 4. Work with the wider Academic Career Development Forum and NIHR Academy to integrate local academic career development initiatives with national schemes and activities. 5. Share good academic career development practice and learn from others. 6. Support the timely collation of information on BRC-aligned NIHR Academy members and Associate members to be reported to NIHR, supported by the BRC administration team. 7. Communicate NIHR academic research opportunities to BRC-aligned NIHR Academy members. 8. Work with the Southampton Academy of Research making an active contribution to the UHS Pioneering Research and Innovation strategy. 9. Work closely with the UoS Faculty of Medicine Associate Dean for Research and School of Health Sciences Deputy Head of School (Research), the Director of the Southampton Clinical Academic Training Scheme (SoCATS) and other infrastructure Academic Career Development Leads and relevant Graduate School Directors to achieve coordinated activity across the Southampton partnership. 10. Actively engage with NIHR via the NIHR Academy and/or Research Council training initiatives and represent Southampton at NIHR national and regional training meetings. 11. Maintain and develop Southampton’s reputation as a leading centre for health research talent management. 12. Help support and develop the SoAR BRC early career researcher champions/Theme Links, as appropriate to agreed portfolio. 13. Together with the Academic Career Development Lead, advise the BRC on strategic direction for research training and education. Strategy will be developed in the context of NIHR Academy strategy and policy and the Trust and University strategic visions and operational structures. 14. Together with the Academic Career Development Lead, identify research training and education priorities, representing clinical academic staff/units engaged or wishing to engage in clinical academic career pathways in relation to translational research. 15. Deputise for the BRC Academic Career Development Lead at BRC Board meetings, Scientific and Management Committee meetings, and Operational Strategic Delivery Leads meetings as required. 16. Promote the BRC through public speaking, public engagement and networking. 17. Contribute to the integrated approach to research governance and management, upholding standards of research governance through facilitating training and education opportunities. Person specification Criteria – Qualifications, knowledge and experience Essential * PhD or equivalent professional qualifications and experience in translational research * Detailed knowledge of translational research * A sustained record of excellence in teaching and learning activities in translational research Desirable * Sustained record of capacity building in research through supervising, championing, supporting or mentoring individuals and/or programmes * Membership of national or international advisory bodies and/or learned societies. Involvement in national and international academies of science and organisations. Membership of national committees that manage fellowship schemes and training initiatives * Experience of career mentoring Criteria – Planning/leadership and organising Essential * Proven leadership ability in University, NHS or other settings Desirable * Qualification in leadership Criteria – Problem solving and initiative Essential * Proven ability to implement successful change management initiatives and formulate them in the context of career development/support Criteria – Management and teamwork Essential * Proven ability to oversee people and resource management processes in order to deliver key activities * Proven ability to recognise and deal with obstacles and difficulties so the team can deliver Criteria – Communicating and influencing Essential * Proven ability to establish and build relationships with multiple stakeholders * Able to contribute to the development of the UHS/UoS partnerships profile * Proven ability to use influence to develop positions or strategies Criteria – Other skills and behaviours Essential * Compliance with relevant Health & Safety issues * Positive attitude to colleagues and students Criteria – Special requirements Essential * Able to attend national meetings as required
Url: /Media/Southampton-Clinical-Research/Downloads/NIHR-BRC-Theme-ACDL.docx

NIHR BRC Theme Academic Career development Leads

Description: NIHR BRC Theme Academic Career Development Lead Call for Expressions of Interest The University Hospital Southampton NHS Foundation Trust (UHS) and University of Southampton (UoS) are inviting an Expression of Interest for the role of NIHR BRC Theme Academic Career Development Lead (ACDL). The NIHR Southampton Biomedical Research Centre takes new discoveries, treatments and technologies into the clinic, using unique tools, facilities and world-changing expertise across our five key research areas. We aim to improve people's health and resilience throughout life, generating the next generation of improved and personalised treatments. Our Theme ACDLs are responsible for supporting the development, delivery, monitoring and evaluation of the Academic Career Development Strategy. The strategy aims to attract, retain and develop individuals along the career pathway, from pre-doctoral scholar to senior research leader, supporting equity of opportunity, achieving a diverse workforce, and developing talented individuals from all relevant professional backgrounds (doctors, nurses, AHPs, pharmacists, scientists, infrastructure support staff). The BRC achieves this through strategic investment in talented people using open, transparent, competitive processes via mentoring programmes, leadership development programmes, and focussed learning based on an analysis of learning needs. The partnership seeks to appoint an individual to work with the BRC ACDL to deliver the strategy for the current BRC funding cycle (2022-2027). Specifically, we wish to appoint an individual employed by University Hospital Southampton NHSFT or University of Southampton who has an appreciation and passion for developing the research careers of research scientists, nurses, midwives, allied health professionals, healthcare scientists, pharmacists and doctors. It is anticipated that, alongside delivery of the BRC’s offer for relevant professional groups, the portfolio of responsibility for each ACDL will be negotiated in relation to specific Themes and project work relevant to their experience, ensuring there is parity of activity and responsibilities across the ACDL team. The Theme ACDL will be formally identified and recognised within their institution. The Theme ACDL will be named in any training materials, induction packs and other communication tools relevant to their engagement with individuals on an academic track. The successful candidate will have strong leadership and management skills and a track record of building experimental research capacity and capability. Expressions of interest should be made through submission of an up-to-date curriculum vitae (CV) and covering letter to brc-applications@uhs.nhs.uk. The covering letter should detail your reasons for applying and what you would bring to the role. The deadline for submissions of expressions of interest is 12:00 midday on Monday 17th March 2025. Expressions of interest will be shortlisted and interviews will be held on Friday 21st March 2025. See Appendix 1 for role description and person specification. For further information, please contact Associate Professor Malcolm West, the BRC Academic Career Development Lead at m.west@soton.ac.uk. Appendix 1 Southampton BRC Theme Academic Career Development Lead Role Description and Person Specification Job Role Role title: Southampton BRC Theme Academic Career Development Lead (ACDL) Time commitment: Up to 1 programmed activity or up to 0.1 WTE Role accountable to1: BRC Academic Career Development Lead BRC Director BRC Senior Programme Manager 1 Line management arrangements for the substantive post held by the individual will remain unchanged Posts works closely with: BRC Theme ACDLs, BRC Theme Leads, UHS R&D Director, UoS Associate Dean for Research Faculty of Medicine and Deputy Head of School (Research) School of Health Science, relevant UoS Graduate School Directors, other Southampton-aligned NIHR Academic Career Development Leads and Infrastructure Directors, BRC EDI Lead, Head of SCEI Background Reflecting our commitment to career development, the Southampton BRC has developed an academic career development team to help build the organisation’s leadership capacity and capability. This consists of tailored education, training and career development of our BRC research and infrastructure workforce, guided and overseen by the BRC Academic Career Development Lead. The Theme ACDLs form part of this team. Vision Our vision is to attract, retain and develop individuals along the career pathway, from pre-doctoral scholar to senior research leader, supporting equity of opportunity, achieving a diverse workforce, and developing talented individuals from all relevant professional backgrounds (doctors, nurses, AHPs, pharmacists, scientists, infrastructure support staff). Key primary responsibilities 1. Support Southampton BRC’s Academic Career Development Strategy and delivery plan in collaboration with the wider Academic Career Development team. 2. Undertake responsibility for specific Themes and project work (e.g. PhD Studentship programme), consulting with the BRC Academic Career Development Lead. 3. Be an active participant in NIHR Academy Academic Career Development Forum meetings. 4. Work with the wider Academic Career Development Forum and NIHR Academy to integrate local academic career development initiatives with national schemes and activities. 5. Share good academic career development practice and learn from others. 6. Support the timely collation of information on BRC-aligned NIHR Academy members and Associate members to be reported to NIHR, supported by the BRC administration team. 7. Communicate NIHR academic research opportunities to BRC-aligned NIHR Academy members. 8. Work with the Southampton Academy of Research making an active contribution to the UHS Pioneering Research and Innovation strategy. 9. Work closely with the UoS Faculty of Medicine Associate Dean for Research and School of Health Sciences Deputy Head of School (Research), the Director of the Southampton Clinical Academic Training Scheme (SoCATS) and other infrastructure Academic Career Development Leads and relevant Graduate School Directors to achieve coordinated activity across the Southampton partnership. 10. Actively engage with NIHR via the NIHR Academy and/or Research Council training initiatives and represent Southampton at NIHR national and regional training meetings. 11. Maintain and develop Southampton’s reputation as a leading centre for health research talent management. 12. Help support and develop the SoAR BRC early career researcher champions/Theme Links, as appropriate to agreed portfolio. 13. Together with the Academic Career Development Lead, advise the BRC on strategic direction for research training and education. Strategy will be developed in the context of NIHR Academy strategy and policy and the Trust and University strategic visions and operational structures. 14. Together with the Academic Career Development Lead, identify research training and education priorities, representing clinical academic staff/units engaged or wishing to engage in clinical academic career pathways in relation to translational research. 15. Deputise for the BRC Academic Career Development Lead at BRC Board meetings, Scientific and Management Committee meetings, and Operational Strategic Delivery Leads meetings as required. 16. Promote the BRC through public speaking, public engagement and networking. 17. Contribute to the integrated approach to research governance and management, upholding standards of research governance through facilitating training and education opportunities. Person specification Criteria – Qualifications, knowledge and experience Essential • PhD or equivalent professional qualifications and experience in translational research • Detailed knowledge of translational research • A sustained record of excellence in teaching and learning activities in translational research Desirable • Sustained record of capacity building in research through supervising, championing, supporting or mentoring individuals and/or programmes • Membership of national or international advisory bodies and/or learned societies. Involvement in national and international academies of science and organisations. Membership of national committees that manage fellowship schemes and training initiatives • Experience of career mentoring Criteria – Planning/leadership and organising Essential • Proven leadership ability in University, NHS or other settings Desirable • Qualification in leadership Criteria – Problem solving and initiative Essential • Proven ability to implement successful change management initiatives and formulate them in the context of career development/support Criteria – Management and teamwork Essential • Proven ability to oversee people and resource management processes in order to deliver key activities • Proven ability to recognise and deal with obstacles and difficulties so the team can deliver Criteria – Communicating and influencing Essential • Proven ability to establish and build relationships with multiple stakeholders • Able to contribute to the development of the UHS/UoS partnerships profile • Proven ability to use influence to develop positions or strategies Criteria – Other skills and behaviours Essential • Compliance with relevant Health & Safety issues • Positive attitude to colleagues and students Criteria – Special requirements Essential • Able to attend national meetings as required
Url: /Media/Southampton-Clinical-Research/Downloads/NIHR-BRC-Theme-Academic-Career-development-Leads.pdf

Welcome to the adult home ventilation service - patient information

Description: This factsheet introduces the adult home ventilation service and explains what will happen as you move across to this service from the children's long-term ventilation (LTV) service, so you know what to expect.
Url: /Media/UHS-website-2019/Patientinformation/Respiratory/Welcome-to-the-adult-home-ventilation-service-3740-PIL.pdf

ImatinibChronic

Description: Chemotherapy Protocol Chronic Myeloid Leukaemia Regimen IMATINIB (chronic phase) • CML – Imatinib (chronic phase) Indication • As the preferred first-line treatment for people with Philadelphia-chromosomepositive chronic myeloid leukaemia (CML) in the chronic phase. • As the preferred option for the treatment of people with Philadelphia-chromosomepositive CML who present in the chronic phase and then progress to the accelerated phase or blast crisis, if they have not received imatinib previously. Toxicity Drug Imatinib Adverse Effect Oedema, fatigue, rash, nausea/vomiting, diarrhoea, cardiotoxicity, haemorrhage, muscle spasm/cramps, musculoskeletal pain, headache, periorbital oedema, raised liver enzymes, hepatitis, weight gain, renal impairment The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Drugs • FBC, LFTs and U&Es prior to starting treatment then fortnightly initially increasing to 3 monthly in stable, responding patients. • Consider baseline evaluation of left ventricular ejection fraction in patients with known underlying heart disease or in elderly patients. • Hepatitis B, C and HIV status should be checked prior to starting imatinib therapy. Patients who are carriers of HBV and those with active disease should be discussed with a consultant hepatologist prior to starting imatinib therapy. Dose Modifications The dose modifications listed are for haematological, liver and renal function and drug specific toxicities only. Dose adjustments may be necessary for other toxicities as well. Please discuss all dose reductions / delays with the relevant consultant before prescribing, if appropriate. The approach may be different depending on the clinical circumstances. Version 1 (January 2017) Page 1 of 5 CML-Imatinib (chronic) Haematological Dose modifications for haematological toxicity in the table below are for general guidance only. Always refer to the responsible consultant as any dose reductions or delays will be dependent on clinical circumstances and treatment intent. Haematological toxicity usually presents within eight weeks of starting therapy with imatinib. Consider blood transfusion if the patient is symptomatic of anaemia or has haemoglobin of less than 8g/dL (80g/L). Chronic Phase CML Neutrophils (x109/L) Less than 1 And / or Platelets (x109/L Less than 50 Dose Modifications Stop treatment until the neutrophils are greater than or equal to 1.5x109/L and platelets are greater than or equal to 75x109/L. 1st occurrence – continue 100% dose 2nd occurrence – reduce to 300mg Hepatic Impairment Bilirubin µmol/L Greater than or 3xULN AST/ALT units Greater than 5xULN Dose (% of original dose) Withhold treatment until the bilirubin is less than 1.5xULN or ALT/AST are less than 2.5xULN, then resume treatment at a reduced dose. Reduce the 400mg dose to 300mg, 600mg dose to 400mg and 800mg dose to 600mg. Renal Impairment No dosage adjustment necessary. Long-term treatment with imatinib may be associated with a clinically significant decline in renal function. Renal function should be closely monitored during therapy particularly in those patients exhibiting risk factors for renal dysfunction. If renal dysfunction is observed, appropriate management and treatment should be prescribed in accordance with standard treatment guidelines. Regimen 28 day cycle until disease progression or intolerance (12 cycles will be set in ARIA) Chronic Phase Drug Imatinib Dose 400mg once a day Days 1-28 (inclusive) Administration Oral Starting doses may be increased from 400mg to 600mg or from 600mg to 800mg (given as 400mg twice a day) in patients with chronic phase disease according to the European Version 1 (January 2017) Page 2 of 5 CML-Imatinib (chronic) Haematology Association Guidelines. Patients should be monitored closely following dose escalation given the potential for an increased incidence of adverse reactions at higher dosages. Dose Information • Imatinib is available as 400mg or 100mg tablets. Administration Information • Imatinib at doses of 600mg or below should be given once a day with plenty of water, with or after food. (Doses of 800mg should be administered as 400mg twice a day) • For patients unable to swallow the film-coated tablets, the tablets may be dispersed in a glass of still water or apple juice. The required number of tablets should be placed in the appropriate volume of beverage (approximately 50 ml for a 100 mg tablet, and 200 ml for a 400 mg tablet) and stirred with a spoon. The suspension should be administered immediately after complete disintegration of the tablet(s). Additional Information • The National Patient Safety Alert on oral chemotherapy (NPSA/2008/RRR001) must be followed in relation to imatinib. • It must be made clear to all staff, including those in the community, that imatinib should only be prescribed under the supervision of a consultant haematologist. • Imatinib is a substrate for the cytochrome p450 (CYP) 3A4 isoenzyme. Prescribing imatinib for co-administration with agents that are known to inhibit CYP3A4 should be undertaken with extreme caution. The concomitant use of agents that are strong CYP3A4 inducers should be avoided where possible. Imatinib has the potential to interact with many other agents. Always check for drug interactions. Coding • Procurement – X71.5 • Delivery – X73.1 References 1. National Institute for Health and Care Excellence. Dasatinib, nilotinib and standard-dose imatinib for the first-line treatment of chronic myeloid leukaemia [TA251]. London: National Institute for Health and Care Excellence. 2. Novartis Pharmacueticals UK Limited (2016). Glivec film-coated tablets Summary of Product Characteristics. Online at http://www.medicines.org.uk/emc/medicine/15014, accessed 1 September 2016. 3. University College London Hospitals NHS Foundation Trust (2009). Dosage Adjustment for Cytotoxics in Renal Impairment (Version 3). Online at http://www.londoncancer.org/media/65600/renal-impairment-dosage-adjustmentfor-cytotoxics.pdf, accessed 1 September 2016. Version 1 (January 2017) Page 3 of 5 CML-Imatinib (chronic) REGIMEN SUMMARY Two regimens will be set up in Aria, one for the chronic phase and one for the accelerated phase of the disease. Imatinib (chronic phase) Cycle 1 onwards Day 1-28 1. Imatinib 400mg once a day oral Administration Information Oral chemotherapy Take with or just after food, or a meal. Take with a full glass of water. Imatinib at doses of 600mg or below should be given once a day. Doses of 800mg should be administered as 400mg twice a day. Please supply the nearest original whole pack according to local practice eg 30 tablets per 28 day cycle Version 1 (January 2017) Page 4 of 5 CML-Imatinib (chronic) DOCUMENT CONTROL Version Date Amendment Written By Approved By 1 January 2017 None Eleanor Taylor Pharmacist Dr Andrew Duncombe Consultant Haematologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors that occur as a result of following these guidelines. Version 1 (January 2017) Page 5 of 5 CML-Imatinib (chronic)
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/CML/ImatinibChronic.pdf

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Welcome to the adult home ventilation service - patient information

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