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RPACEBOM - Bleomycin-Cyclophosphamide-Doxorubicin-Etoposide-Methotrexate-Prednisolone-Rituximab-Vincristine

Description: Chemotherapy Protocol LYMPHOMA BLEOMYCIN-CYCLOPHOSPHAMIDE-DOXORUBICIN-ETOPOSIDE-METHOTREXATEPREDNISOLONE-RITUXIMAB-VINCRISTINE Regimen (RPACEBOM) Lymphoma
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Lymphoma/RPACEBOM-Bleomycin-Cyclophosphamide-Doxorubicin-Etoposide-Methotrexate-Prednisolone-Rituximab-Vincristine.pdf

RGDP-Cisplatin-Dexamethasone-Gemcitabine-Rituximab

Description: Chemotherapy Protocol LYMPHOMA CISPLATIN-DEXAMETHASONE-GEMCITABINE-RITUXIMAB (RGDP) Regimen • Lymphoma – RGDP-Cisplatin-Dexamethasone-Gemcitabine-Rituxima
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Lymphoma/RGDP-Cisplatin-Dexamethasone-Gemcitabine-Rituximab.pdf

RGCVP-Cyclophosphamide-Gemcitabine-Prednisolone-Rituximab-Vincristine Ver 1.2

Description: Chemotherapy Protocol LYMPHOMA CYCLOPHOSPHAMIDE-GEMCITABINE-PREDNISOLONE-RITUXIMAB-VINCRISTINE (RGCVP) Regimen Lymphoma–RGCVP-Cyclophosphamide-Gemcitabine
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Lymphoma/RGCVP-Cyclophosphamide-Gemcitabine-Prednisolone-Rituximab-Vincristine-Ver-1.2.pdf

RFC PO (Lite) - Cyclophosphamide-Fludarabine- Rituximab PO (Lite) Ver 1.2

Description: Chemotherapy Protocol LYMPHOMA CYCLOPHOSPHAMIDE–FLUDARABINE–RITUXIMAB (RFC Oral Lite) Regimen Lymphoma – RFC PO (Lite) - Cyclophosphamide-Fludarabine-Ritu
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Lymphoma/RFC-PO-Lite-Cyclophosphamide-Fludarabine-Rituximab-PO-Lite-Ver-1.2.pdf

REPOCH (dose adjusted)-Cyclophosphamide-Doxorubicin-Etoposide-Prednisolone-Rituximab-Vincristine

Description: Chemotherapy Protocol LYMPHOMA REPOCH - CYCLOPHOSPHAMIDE-DOXORUBICIN-ETOPOSIDE-PREDNISOLONERITUXIMAB-VINCRISTINE (Dose adjusted regimen) There are multipl
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Lymphoma/REPOCH-dose-adjusted-Cyclophosphamide-Doxorubicin-Etoposide-Prednisolone-Rituximab-Vincristine.pdf

RCVP-Cyclophosphamide-Prednisolone-Rituximab-Vincristine Ver 1.2

Description: Chemotherapy Protocol LYMPHOMA CYCLOPHOSPHAMIDE-PREDNISOLONE-RITUXIMAB-VINCRISTINE (RCVP) Regimen Lymphoma – RCVP-Cyclophosphamide-Prednisolone-Rituximab-
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Lymphoma/RCVP-Cyclophosphamide-Prednisolone-Rituximab-Vincristine-Ver-1.2.pdf

RCHOP(21)-Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine (21) Ver 1.2

Description: Chemotherapy Protocol LYMPHOMA CYCLOPHOSPHAMIDE-DOXORUBICIN-PREDNISOLONE-RITUXIMAB-VINCRISTINE (21) (RCHOP 21) There are multiple versions of this protocol in use. Please ensure you have the correct protocol for the relevant diagnosis. Regimen Lymphoma – RCHOP(21)-Cyclophosphamide-Doxorubicin-Prednisolone-RituximabVincristine (21) Indication CD20 positive Non-Hodgkin’s Lymphoma Toxicity Drug Adverse Effect Cyclophosphamide Dysuria, haemorrhagic cystitis (rare), taste disturbances Doxorubicin Prednisolone Rituxumab Vincristine Cardiomyopathy, alopecia, urinary discolouration (red), Weight gain, gastro-intestinal disturbances, hyperglycaemia, CNS disturbances, cushingoid changes, glucose intolerance Severe cytokine release syndrome, increased incidence of infective complications, progressive multifocal leukoencephalopathy Peripheral neuropathy, constipation, jaw pain 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 day one of treatment Check hepatitis B status before starting rituximab Ensure adequate cardiac function before starting therapy. Baseline LVEF should be measured in patients with a history of cardiac problems, cardiac risk factors or in the elderly. Discontinue doxorubicin if cardiac failure develops Version 1.2 (Jan 2015) Page 1 of 11 Lymphoma-RCHOP(21)-Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine (21) Dose Modifications The dose modifications listed are for haematological, liver and renal function and limited drug specific toxicities. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be re-escalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. 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. Low counts can be a consequence of bone marrow infiltration as well as drug toxicity. Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Dose modifications based on haematological parameters apply to cyclophosphamide and doxorubicin only Neutrophils (x109/L) Less than 1 on proposed day 1 of cycle Grade 4 neutropenia or any febrile neutropenia following any cycle Grade 4 neutropenia leading to infection despite G-CSF support Grade 4 neutropenia recurs despite 50% dose reduction in cyclophosphamide and doxorubicin Platelets (x109/L) Less than 100 on proposed day 1 of cycle Grade 4 thrombocytopenia following any cycle Grade 4 thrombocytopenia recurs despite 50% dose reduction in cyclophosphamide and doxorubicin Dose Modifications (cyclophosphamide and doxorubicin) Delay therapy until neutrophils are greater than or equal to 1x109/L Consider G-CSF as secondary prophylaxis. Reconsider treatment options if not recovered after 14 days. Give G-CSF with all subsequent cycles Reduce dose of cyclophosphamide and doxorubicin by 50% for all subsequent cycles Stop treatment Dose Modifications (cyclophosphamide and doxorubicin) Delay therapy until platelets are greater or equal to 100x109/L Reconsider treatment options if not recovered after 14 days. Reduce dose of cyclophosphamide and doxorubicin by 50% for all subsequent cycles Stop treatment Version 1.2 (Jan 2015) Page 2 of 11 Lymphoma-RCHOP(21)-Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine (21) Hepatic Impairment Please note that the approach may be different where abnormal liver function tests are due to disease involvement. Drug Cyclophosphamide Bilirubin (μmol/L) AST/ALT (units/L) Dose (%of original dose) Evidence suggest dose modification not necessary. Doxorubicin less than *30 *30-50 and and/or 51-85 more than 85 2-3xULN More than 3xULN N/A N/A 75% 50% 25% omit Rituximab N/A N/A No dose adjustment needed *30-51 or 60-180 50% Vincristine more than 51 and normal 50% more than 51 and more than 180 omit * Lower limit reflects local practice and may differ from published sources. Renal Impairment Drug Cyclophosphamide** Creatinine Clearance (ml/min) more than 20 10-20 less than 10 Dose (% of original dose) 100% 75% 50% Doxorubicin less than 10 Consider dose reduction in severe renal failure Rituximab N/A No dose adjustment needed Vincristine N/A No dose adjustment needed **Consider mesna in patients with pre-existing bladder disorders. Give an oral dose of 40% of the cyclophosphamide dose (rounded upwards to the nearest 400mg) at 0, 2 and 6 hours after the administration of the cyclophosphamide. Version 1.2 (Jan 2015) Page 3 of 11 Lymphoma-RCHOP(21)-Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine (21) 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. Doxorubicin Discontinue doxorubicin if cardiac failure develops Rituximab Infusion related adverse reactions have been observed in 10% of patients treated with rituximab. Rituximab administration is associated with the onset of cytokine release syndrome. This condition is characterised by severe dyspnoea, often accompanied by bronchospasm and hypoxia, in addition to fever, chills, rigors, urticaria, and angioedema. It may be associated with some features of tumour lysis syndrome such as hyperuricaemia, hyperkalaemia, hypocalcaemia, acute renal failure, elevated lactate dehydrogenase (LDH) and can lead to acute respiratory failure and death. This effect on the lungs may be accompanied by events such as pulmonary interstitial infiltration or oedema, visible on a chest x-ray. Cytokine release syndrome frequently occurs within one or two hours of initiating the first infusion. Hypersensitivity reactions, including anaphylaxis, have been reported following the intravenous administration of proteins. In contrast to cytokine release syndrome, true hypersensitivity reactions typically occur within minutes of starting the infusion. Medicinal products for the treatment of allergic reactions should be available for immediate use in the event of hypersensitivity developing during the administration of rituximab. Use of rituximab maybe associated with an increased risk of progressive multifocal leukoencephalopathy (PML). Patients must be monitored at regular intervals for any new or worsening neurological, cognitive or psychiatric symptoms that may be suggestive of PML. If PML is suspected, further dosing must be suspended until PML has been excluded. If PML is confirmed the rituximab must be permanently discontinued. The presence of a viral upper respiratory tract infection at the time of treatment may increase the risk of rituximab associated hepatotoxicity. Patients should be assessed for any cold or flu-like symptoms prior to treatment Vincristine Reduce the vincristine dose to 1mg if a NCI-CTC grade 2 motor or grade 3 sensory neurological toxicity occurs. For higher toxicity grades or if toxicity increases despite dose reduction stop the vincristine. Version 1.2 (Jan 2015) Page 4 of 11 Lymphoma-RCHOP(21)-Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine (21) Regimen 21 day cycle for 6 cycles Drug Cyclophosphamide Dose 750mg/m2 Days Administration 1 Intravenous bolus over 10 minutes Doxorubicin Rituximab Vincristine Prednisolone 50mg/m2 375mg/m2 1.4mg/m2 (max 2mg) 100mg 1 Intravenous bolus over 10 minutes 1 1 1, 2, 3, 4, 5 Intravenous infusion in 500ml sodium chloride 0.9% Intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes Oral Consider initial dose reduction in patients over 70 years of age. Doses may be escalated up to full dose on subsequent cycles according to tolerability. Dose Information Cyclophosphamide will be dose banded according to the CSCCN agreed bands Doxorubicin will be dose banded according to the CSCCN agreed bands The maximum lifetime cumulative dose of doxorubicin is 450mg/m². However prior radiotherapy to mediastinal/pericardial area should receive a lifetime cumulative doxorubicin dose of no more than 400mg/m² Rituximab will be dose rounded to the nearest 100mg (up if half way) Vincristine dose will be rounded to the nearest 0.1mg (up if halfway) The maximum dose of vincristine is 2mg Version 1.2 (Jan 2015) Page 5 of 11 Lymphoma-RCHOP(21)-Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine (21) Administration Information Extravasation Cyclophosphamide – neutral Doxorubicin – vesicant Rituximab - neutral Vincristine - vesicant Other Prednisolone should be taken in the morning with or after food. Administration of prednisolone begins on the morning of chemotherapy. The rate of administration of rituximab varies. Please refer to the rituximab administration guidelines. Additional Therapy Antiemetics 15-30 minutes prior to chemotherapy - ondansetron 8mg oral or intravenous As take home medication - metoclopramide 10mg three times a day when required oral - ondansetron 8mg twice a day for 3 days oral Rituximab pre-medication 30 minutes prior to rituximab - chlorphenamine 10mg intravenous - paracetamol 1000mg oral On the morning of treatment - prednisolone 100mg oral to be self administered by the patient on the morning of treatment and for four days after rituximab treatment (this is part of the chemotherapy schedule as well as rituximab pre-medication) Version 1.2 (Jan 2015) Page 6 of 11 Lymphoma-RCHOP(21)-Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine (21) Rituximab infusion reactions - hydrocortisone 100mg intravenous when required for rituximab infusion related reactions - salbutamol 2.5mg nebule when required for rituximab related bronchospasm - consider pethidine 25-50mg intravenous for rituximab related rigors that fail to respond to steroids. Allopurinol 300mg once a day oral for the first cycle only Consider anti-infective prophylaxis in high risk patients, including: - aciclovir 400mg twice a day oral - co-trimoxazole 960mg once a day oral on Monday, Wednesday and Friday only Mouthwashes according to local or national policy on the treatment of mucositis 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 Agency report NPSA/2008/RRR04 must be followed in relation to intravenous administration of vinca alkaloids. Coding (OPCS 4.6) Procurement – X71.4 Delivery – X72.2 References 1.Coiffier B, Lepage E, Briere J et al. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large B cell lymphoma. N Engl J Med 2002; 346: 235-242. 2.NICE guidance - TA65 Non-Hodgkin’s Lymphoma - rituximab. September 2003 3.NICE guidance – TA137 Lymphoma (follicular non-Hodgkin’s) rituximab. February 2008 4.NICE guidance – TA243 Rituximab for the first-line treatment of stage III-IV follicular lymphoma. January 2012 5.Pfreundschuh M, Trümper L, Österborg A et al. CHOP-like chemotherapy plus rituximab versus CHOP-like chemotherapy alone in young patients with good-prognosis diffuse large-B-cell lymphoma: a randomised controlled trial by the MabThera International Trial (MInT) Group. Lancet Oncol 2006; 7: 379-91. Version 1.2 (Jan 2015) Page 7 of 11 Lymphoma-RCHOP(21)-Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine (21) REGIMEN SUMMARY RCHOP(21)-Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine (21) Cycle 1 1. Warning – Check patient has taken the prednisolone dose* 2. Chlorphenamine 10mg intravenous 3. Paracetamol 1000mg oral 4. Rituximab 375mg/m2 intravenous infusion in 500ml sodium chloride 0.9% as per the rituximab administration guidelines 5. Ondansetron 8mg oral or intravenous injection 6. Doxorubicin 50mg/m2 intravenous bolus over 10 minutes 7. Vincristine 1.4mg/m2 (max 2mg) intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes 8. Cyclophosphamide 750mg/m2 intravenous bolus over 10 minutes 9. Hydrocortisone 100mg intravenous once only when required for the relief of rituximab infusion related reactions 10. Salbutamol 2.5mg nebule once only when required for the relief of rituximab related bronchospasm Take Home Medicines 11. Prednisolone 100mg once a day on the morning of the next treatment ** 12. Prednisolone 100mg once a day for 4 days oral (starting on day 2)** 13. Metoclopramide 10mg three times a day when required oral 14. Ondansetron 8mg twice a day for 3 days oral starting on the evening of day one of treatment 15. Allopurinol 300mg once a day oral for 21 days Version 1.2 (Jan 2015) Page 8 of 11 Lymphoma-RCHOP(21)-Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine (21) Cycles 2, 3, 4 and 5 1. Warning – Check patient has taken the prednisolone dose* 2. Chlorphenamine 10mg intravenous 3. Paracetamol 1000mg oral 4. Rituximab 375mg/m2 intravenous infusion in 500ml sodium chloride 0.9% as per the rituximab administration guidelines 5. Ondansetron 8mg oral or intravenous injection 6. Doxorubicin 50mg/m2 intravenous bolus over 10 minutes 7. Vincristine 1.4mg/m2 (max 2mg) intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes 8. Cyclophosphamide 750mg/m2 intravenous bolus over 10 minutes 9. Hydrocortisone 100mg intravenous once only when required for the relief of rituximab infusion related reactions 10. Salbutamol 2.5mg nebule once only when required for the relief of rituximab related bronchospasm Take Home Medicines 11. Prednisolone 100mg once a day on the morning of the next treatment** 12. Prednisolone 100mg once a day for 4 days oral (starting on day 2)** 13. Metoclopramide 10mg three times a day when required oral 14. Ondansetron 8mg twice a day for 3 days oral starting on the evening of day one of treatment Cycle 6 1. Warning – Check patient has taken the prednisolone dose* 2. Chlorphenamine 10mg intravenous 3. Paracetamol 1000mg oral 4. Rituximab 375mg/m2 intravenous infusion in 500ml sodium chloride 0.9% as per the rituximab administration guidelines 5. Ondansetron 8mg oral or intravenous injection 6. Doxorubicin 50mg/m2 intravenous bolus over 10 minutes Version 1.2 (Jan 2015) Page 9 of 11 Lymphoma-RCHOP(21)-Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine (21) 7. Vincristine 1.4mg/m2 (max 2mg) intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes 8. Cyclophosphamide 750mg/m2 intravenous bolus over 10 minutes 9. Hydrocortisone 100mg intravenous once only when required for the relief of rituximab infusion related reactions 10. Salbutamol 2.5mg nebule once only when required for the relief of rituximab related bronchospasm Take Home Medicines 11. Prednisolone 100mg once a day for 4 days oral (starting on day 2) 12. Metoclopramide 10mg three times a day when required oral 13. Ondansetron 8mg twice a day for 3 days oral starting on the evening of day one of treatment Administration information * Please check the patient has taken prednisolone 100mg oral on the morning of rituximab administration. On occasions where individuals attend for treatment and have forgotten to take the prednisolone dose please administer prednisolone 100mg oral 30 minutes prior to rituximab administration. **The prednisolone may be dispensed as a single supply in one container or as two containers depending on local preference Version 1.2 (Jan 2015) Page 10 of 11 Lymphoma-RCHOP(21)-Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine (21) DOCUMENT CONTROL Version Date Amendment Written By Approved By Header changed Toxicities removed Hepatic & renal tables updated Metoclopramide dose changed to 10mg Donna Kimber 1.2 Jan 2015 Bolus removed from intravenous Pharmacy bolus throughout text Technician Mucositis recommendation changed Disclaimer added Document control reordered “In patients over 70 years of age consider using vincristine 1mg. Where 1.1 July 2012 appropriate dose reduction of other agents may be considered at cycle one” changed to “Consider initial dose Rebecca Wills Pharmacist reduction in patients over 70 years of age.” 1 April 2012 None Rebecca Wills Pharmacist Dr Debbie Wright Pharmacist Rebecca Wills Pharmacist Dr Debbie Wright Pharmacist Dr Andrew Davies Consultant Medical Oncologist Dr Alison Milne 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 Hospitals 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 which occur as a result of following these guidelines. Version 1.2 (Jan 2015) Page 11 of 11 Lymphoma-RCHOP(21)-Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine (21)
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Lymphoma/RCHOP21-Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine-21-Ver-1.2.pdf

RCHOP(14)-Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine (14) Ver 1.2

Description: Chemotherapy Protocol LYMPHOMA CYCLOPHOSPHAMIDE-DOXORUBICIN-PREDNISOLONE-RITUXIMAB-VINCRISTINE- (14) (RCHOP 14) There are multiple versions of this protocol in use. Please ensure you have the correct protocol for the relevant diagnosis. Regimen Lymphoma – RCHOP(14)-Cyclophosphamide-Doxorubicin-Prednisolone-RituximabVincristine-(14) Indication CD20 positive Non-Hodgkin’s Lymphoma Toxicity Drug Adverse Effect Cyclophosphamide Dysuria, haemorrhagic cystitis (rare), taste disturbances Doxorubicin Prednisolone Rituxumab Vincristine Cardiomyopathy, alopecia, urinary discolouration (red), Weight gain, gastro-intestinal disturbances, hyperglycaemia, CNS disturbances, cushingoid changes, glucose intolerance Severe cytokine release syndrome, increased incidence of infective complications, progressive multifocal leukoencephalopathy Peripheral neuropathy, constipation, jaw pain 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 day one of treatment Check hepatitis B status before starting rituximab Ensure adequate cardiac function before starting therapy. Baseline LVEF should be measured in patients with a history of cardiac problems, cardiac risk factors or in the elderly. Discontinue doxorubicin if cardiac failure develops Version 1.2 (Jan 2015) Page 1 of 11 Lymphoma-RCHOP(14)-Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine (14) Dose Modifications The dose modifications listed are for haematological, liver and renal function and limited drug specific toxicities. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be re-escalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. 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. Low counts can be a consequence of bone marrow infiltration as well as drug toxicity. Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Dose modifications based on haematological parameters apply to cyclophosphamide and doxorubicin only Neutrophils (x109/L) Less than 1 on proposed day 1 of cycle Platelets (x109/L) Less than 100 on proposed day 1 of cycle Dose Modifications (cyclophosphamide and doxorubicin) Delay therapy until neutrophils recover to 1x109/L or more. Continue growth factors during this time. If recovery occurs within 7 days continue with full dose. If recovery takes between 7 and 14 days continue with 75% of the original dose. If recovery takes longer than 14 days continue with 50% of the original dose. Dose Modifications (cyclophosphamide and doxorubicin) Delay therapy until neutrophils recover to 100x109/L or more. If recovery occurs within 7 days continue with full dose. If recovery takes between 7 and 14 days continue with 75% of the original dose. If recovery takes longer than 14 days continue with 50% of the original dose. Version 1.2 (Jan 2015) Page 2 of 11 Lymphoma-RCHOP(14)-Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine (14) Hepatic Impairment Please note that the approach may be different where abnormal liver function tests are due to disease involvement. Drug Cyclophosphamide Bilirubin (μmol/L) AST/ALT (units/L) Dose (% of original dose) Evidence suggests dose modification not necessary Doxorubicin Rituximab less than *30 *30-50 and and/or 51-85 more than 85 2-3xULN More than 3xULN N/A N/A 75% 50% 25% omit N/A N/A No dose adjustment needed *30-51 or 60-180 Vincristine more than 51 and normal more than 51 and more than 180 *Lower limit reflects local practice and may vary from published sources 50% 50% omit Renal Impairment Drug Cyclophosphamide** Creatinine Clearance (ml/min) more than 20 10-20 less than 10 Dose (% of original dose) 100% 75% 50% Doxorubicin less than 10 Consider dose reduction in severe renal failure Rituximab N/A No dose adjustment needed Vincristine N/A No dose adjustment needed **Consider mesna in patients with pre-existing bladder disorders. Give an oral dose of 40% of the cyclophosphamide dose (rounded upwards to the nearest 400mg) at 0, 2 and 6 hours after the administration of the cyclophosphamide. Version 1.2 (Jan 2015) Page 3 of 11 Lymphoma-RCHOP(14)-Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine (14) 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. Doxorubicin Discontinue doxorubicin if cardiac failure develops Rituximab Infusion related adverse reactions have been observed in 10% of patients treated with rituximab. Rituximab administration is associated with the onset of cytokine release syndrome. This condition is characterised by severe dyspnoea, often accompanied by bronchospasm and hypoxia, in addition to fever, chills, rigors, urticaria, and angioedema. It may be associated with some features of tumour lysis syndrome such as hyperuricaemia, hyperkalaemia, hypocalcaemia, acute renal failure, elevated lactate dehydrogenase (LDH) and can lead to acute respiratory failure and death. This effect on the lungs may be accompanied by events such as pulmonary interstitial infiltration or oedema, visible on a chest x-ray. Cytokine release syndrome frequently occurs within one or two hours of initiating the first infusion. Hypersensitivity reactions, including anaphylaxis, have been reported following the intravenous administration of proteins. In contrast to cytokine release syndrome, true hypersensitivity reactions typically occur within minutes of starting the infusion. Medicinal products for the treatment of allergic reactions should be available for immediate use in the event of hypersensitivity developing during the administration of rituximab. Use of rituximab maybe associated with an increased risk of progressive multifocal leukoencephalopathy (PML). Patients must be monitored at regular intervals for any new or worsening neurological, cognitive or psychiatric symptoms that may be suggestive of PML. If PML is suspected, further dosing must be suspended until PML has been excluded. If PML is confirmed the rituximab must be permanently discontinued. The presence of a viral upper respiratory tract infection at the time of treatment may increase the risk of rituximab associated hepatotoxicity. Patients should be assessed for any cold or flu-like symptoms prior to treatment Vincristine Reduce the vincristine dose to 1mg if a NCI-CTC grade 2 motor or grade 3 sensory neurological toxicity occurs. For higher toxicity grades or if toxicity increases despite dose reduction stop the vincristine. Version 1.2 (Jan 2015) Page 4 of 11 Lymphoma-RCHOP(14)-Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine (14) Regimen 14 day cycle for 6 cycles (an additional 2 doses of rituximab may be given at 14 day intervals following R-CHOP 14) Drug Cyclophosphamide Dose 750mg/m2 Days Administration 1 Intravenous bolus over 10 minutes Doxorubicin Rituximab Vincristine Prednisolone 50mg/m2 375mg/m2 1.4mg/m2 (max 2mg) 100mg 1 Intravenous bolus over 10 minutes 1 1 1, 2, 3, 4, 5 Intravenous infusion in 500ml sodium chloride 0.9% Intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes Oral Consider initial dose reduction in patients over 70 years of age. Doses may be escalated up to full dose on subsequent cycles according to tolerability. Dose Information Cyclophosphamide will be dose banded according to the CSCCN agreed bands Doxorubicin will be dose banded according to the CSCCN agreed bands The maximum lifetime cumulative dose of doxorubicin is 450mg/m². However prior radiotherapy to mediastinal/pericardial area should receive a lifetime cumulative doxorubicin dose of no more than 400mg/m² Rituximab will be dose rounded to the nearest 100mg (up if half way) Vincristine dose will be rounded to the nearest 0.1mg (up if halfway) The maximum dose of vincristine is 2mg Version 1.2 (Jan 2015) Page 5 of 11 Lymphoma-RCHOP(14)-Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine (14) Administration Information Extravasation Cyclophosphamide – neutral Doxorubicin – vesicant Rituximab - neutral Vincristine - vesicant Other Prednisolone should be taken in the morning with or after food. Administration of prednisolone begins on the morning of chemotherapy. The rate of administration of rituximab varies. Please refer to the rituximab administration guidelines. Additional Therapy Antiemetics 15-30 minutes prior to chemotherapy - ondansetron 8mg oral or intravenous As take home medication - metoclopramide 10mg three times a day when required oral - ondansetron 8mg twice a day for 3 days oral Rituximab pre-medication 30 minutes prior to rituximab - chlorphenamine 10mg intravenous - paracetamol 1000mg oral On the morning of treatment - prednisolone 100mg oral to be self administered by the patient on the morning of treatment and for four days after rituximab treatment (this is part of the chemotherapy schedule as well as rituximab pre-medication) Version 1.2 (Jan 2015) Page 6 of 11 Lymphoma-RCHOP(14)-Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine (14) Rituximab infusion reactions - hydrocortisone 100mg intravenous when required for rituximab infusion related reactions - salbutamol 2.5mg nebule when required for rituximab related bronchospasm - consider pethidine 25-50mg intravenous for rituximab related rigors that fail to respond to steroids. Allopurinol 300mg once a day oral for the first cycle only Growth factor to be continued until the neutrophil count is above 1x109/L. For example - filgrastim or bioequivalent 30 million units once a day from day 4 subcutaneous - lenograstim or bioequivalent 33.6 million units once a day from day 4 subcutaneous - pegfilgrastim or bioequivalent 6mg once only on day 2 subcutaneous Co-trimoxazole 960mg once a day oral on Monday, Wednesday and Friday only Consider aciclovir 400mg twice a day oral in high risk individuals Mouthwashes according to local or national policy on the treatment of mucositis 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 Agency report NPSA/2008/RRR04 must be followed in relation to intravenous administration of vinca alkaloids. Coding (OPCS 4.6) Procurement – X71.4 Delivery – X72.1 References 1. Pfreundscuh M, Schubert J, Ziepert M et al. Six versus eight cycles of bi-weekly CHOP-14 with or without rituximab in elderly patients with aggressive CD20+ B-cell lymphomas: a randomised controlled trial (RICOVER-60). Lancet Oncol. 2008; 9(2):105-16. 2. D Cunningham, P Smith, P Mouncey. A phase III trial comparing R-CHOP 14 and R-CHOP 21 for the treatment of patients with newly diagnosed diffuse large B-cell non-Hodgkin's lymphoma. J Clin Oncol (2009); 27 (15s): 3. NICE guidance - TA65 Non-Hodgkin’s Lymphoma - rituximab. September 2003 4. NICE guidance – TA137 Lymphoma (follicular non-Hodgkin’s) rituximab. February 2008 5. NICE guidance – TA243 Rituximab for the first-line treatment of stage III-IV follicular lymphoma. January 2012 Version 1.2 (Jan 2015) Page 7 of 11 Lymphoma-RCHOP(14)-Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine (14) REGIMEN SUMMARY RCHOP(14)-Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine (14) Cycle 1 1. Warning – Check patient has taken the prednisolone dose. Administration Instructions Please check the patient has taken prednisolone 100mg oral on the morning of rituximab administration. On occasions where individuals attend for treatment and have forgotten to take the prednisolone dose please administer prednisolone 100mg oral 30 minutes prior to rituximab administration. 2. Chlorphenamine 10mg intravenous 3. Paracetamol 1000mg oral 4. Rituximab 375mg/m2 intravenous infusion in 500ml sodium chloride 0.9% as per the rituximab administration guidelines 5. Ondansetron 8mg oral or intravenous 6. Doxorubicin 50mg/m2 intravenous bolus over 10 minutes 7. Vincristine 1.4mg/m2 (max 2mg) intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes 8. Cyclophosphamide 750mg/m2 intravenous bolus over 10 minutes 9. Hydrocortisone 100mg intravenous once only when required for the relief of rituximab infusion related reactions 10. Salbutamol 2.5mg nebule once only when required for the relief of rituximab related bronchospasm Take Home Medicines 11. Prednisolone 100mg once a day on the morning of the next treatment Administration Instructions The prednisolone may be dispensed as a single supply in one container or as two containers depending on local preference 12. Prednisolone 100mg once a day for 4 days oral (starting on day 2) Administration Instructions The prednisolone may be dispensed as a single supply in one container or as two containers depending on local preference 13. Metoclopramide 10mg three times a day when required oral 14. Ondansetron 8mg twice a day for 3 days oral starting on the evening of day one of treatment 15. Allopurinol 300mg once a day oral for 14 days 16. Growth factor as per local formulary choice. - filgrastim or bioequivalent 30 million units once a day for 7 days starting on day 4 of the cycle subcutaneous Version 1.2 (Jan 2015) Page 8 of 11 Lymphoma-RCHOP(14)-Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine (14) - lenograstim or bioequivalent 33.6 million units once a day for 7 days starting on day 4 of the cycle subcutaneous - pegfilgrastim or bioequivalent 6mg once only on day 2 of the cycle subcutaneous 17. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday oral Cycles 2, 3, 4 and 5 1. Warning – Check patient has taken the prednisolone dose. Administration Instructions Please check the patient has taken prednisolone 100mg oral on the morning of rituximab administration. On occasions where individuals attend for treatment and have forgotten to take the prednisolone dose please administer prednisolone 100mg oral 30 minutes prior to rituximab administration. 2. Chlorphenamine 10mg intravenous 3. Paracetamol 1000mg oral 4. Rituximab 375mg/m2 intravenous infusion in 500ml sodium chloride 0.9% as per the rituximab administration guidelines 5. Ondansetron 8mg oral or intravenous 6. Doxorubicin 50mg/m2 intravenous bolus over 10 minutes 7. Vincristine 1.4mg/m2 (max 2mg) intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes 8. Cyclophosphamide 750mg/m2 intravenous bolus over 10 minutes 9. Hydrocortisone 100mg intravenous once only when required for the relief of rituximab infusion related reactions 10. Salbutamol 2.5mg nebule once only when required for the relief of rituximab related bronchospasm Take Home Medicines 11. Prednisolone 100mg once a day on the morning of the next treatment Administration Instructions The prednisolone may be dispensed as a single supply in one container or as two containers depending on local preference 12. Prednisolone 100mg once a day for 4 days oral (starting on day 2) Administration Instructions The prednisolone may be dispensed as a single supply in one container or as two containers depending on local preference 13. Metoclopramide 10mg three times a day when required oral 14. Ondansetron 8mg twice a day for 3 days oral starting on the evening of day one of treatment 15. Growth factor as per local formulary choice. For example; - filgrastim or bioequivalent 30 million units once a day for 7 days starting on day 4 of the cycle subcutaneous Version 1.2 (Jan 2015) Page 9 of 11 Lymphoma-RCHOP(14)-Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine (14) - lenograstim or bioequivalent 33.6 million units once a day for 7 days starting on day 4 of the cycle subcutaneous - pegfilgrastim or bioequivalent 6mg once only on day 2 of the cycle subcutaneous 17. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday oral Cycle 6 1. Warning – Check patient has taken the prednisolone dose. Administration Instructions Please check the patient has taken prednisolone 100mg oral on the morning of rituximab administration. On occasions where individuals attend for treatment and have forgotten to take the prednisolone dose please administer prednisolone 100mg oral 30 minutes prior to rituximab administration. 2. Chlorphenamine 10mg intravenous 3. Paracetamol 1000mg oral 4. Rituximab 375mg/m2 intravenous infusion in 500ml sodium chloride 0.9% as per the rituximab administration guidelines 5. Ondansetron 8mg oral or intravenous 6. Doxorubicin 50mg/m2 intravenous bolus over 10 minutes 7. Vincristine 1.4mg/m2 (max 2mg) intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes 8. Cyclophosphamide 750mg/m2 intravenous bolus over 10 minutes 9. Hydrocortisone 100mg intravenous once only when required for the relief of rituximab infusion related reactions 10. Salbutamol 2.5mg nebule once only when required for the relief of rituximab related bronchospasm Take Home Medicines 11. Prednisolone 100mg once a day for 4 days oral (starting on day 2) 12. Metoclopramide 10mg three times a day when required oral 13. Ondansetron 8mg twice a day for 3 days oral starting on the evening of day one of treatment 14. Growth factor as per local formulary choice. For example; - filgrastim or bioequivalent 30 million units once a day for 7 days starting on day 4 of the cycle subcutaneous - lenograstim or bioequivalent 33.6 million units once a day for 7 days starting on day 4 of the cycle subcutaneous - pegfilgrastim or bioequivalent 6mg once only on day two of the cycle subcutaneous 15. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday oral Version 1.2 (Jan 2015) Page 10 of 11 Lymphoma-RCHOP(14)-Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine (14) DOCUMENT CONTROL Version Date Amendment Written By Approved By Header changed Toxicities removed Hepatic & renal tables updated Metoclopramide dose changed to 10mg Growth factor units updated Donna Kimber 1.2 Jan 2015 Bolus removed from intravenous Pharmacy bolus throughout text Technician Mucositis recommendation changed OPCS codes updated Ondansetron TTO clarified Disclaimer added 1.1 Feb 2013 Co-trimoxazole added as prophylaxis to the supportive treatment and regimen summary Dr Deborah Wright Pharmacist 1 July 2012 None Rebecca Wills Pharmacist Dr Deborah Wright Pharmacist Rebecca Wills Pharmacist Dr Alison Milne Consultant Haematologist Rebecca Wills Pharmacist Dr Andrew Davies Consultant Medical Oncologist Dr Alison Milne 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 Hospitals 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 which occur as a result of following these guidelines. Version 1.2 (Jan 2015) Page 11 of 11 Lymphoma-RCHOP(14)-Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine (14)
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RCEOP-Cyclophosphamide-Etoposide-Prednisolone-Rituximab-Vincristine Ver 1.2

Description: Chemotherapy Protocol LYMPHOMA CYCLOPHOSPHAMIDE-ETOPOSIDE-PREDNISOLONE-RITUXIMAB-VINCRISTINE Regimen (RCEOP) Lymphoma – RCEOP-Cyclophosphamide-Etoposide-Prednisolone-RituximabVincristine Indication Non Hodgkin’s Lymphoma where the use of an anthracycline based regimen is contra-indicated Toxicity Drug Adverse Effect Cyclophosphamide Dysuria, haemorrhagic cystitis (rare), taste disturbances Etoposide Hypotension on rapid infusion, alopecia, hyperbilirubinaemia Vincristine Rituxumab Prednisolone Peripheral neuropathy, constipation, jaw pain Severe cytokine release syndrome, increased incidence of infective complications, progressive multifocal leukoencephalopathy Weight gain, gastro-intestinal disturbances, hyperglycaemia, CNS disturbances, cushingoid changes, glucose intolerance 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 day one of treatment Albumin prior to each cycle Check hepatitis B status before starting treatment with rituximab Dose Modifications The dose modifications listed are for haematological, liver and renal function and some drug specific toxicities only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be re-escalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Version 1.2 (Jan 2015) Page 1 of 11 Lymphoma- RCEOP-Cyclophosphamide-Etoposide-Prednisolone-Rituximab-Vincristine 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. Low counts can be a consequence of bone marrow infiltration as well as drug toxicity. Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Dose modifications based on haematological parameters apply to cyclophosphamide and etoposide only Neutrophils (x109/L) 1 or greater Dose Modifications (cyclophosphamide and etoposide) 100% 1st Occurrence If the intent is curative and growth factor prophylaxis has not been previously given administer 100% of the dose plus prophylactic growth factors. 0.5 – 0.9 Alternatively delay until the neutrophils are 1x109/L or above and then give 75% of the original dose less than 0.5 or febrile neutropenia Platelets (x109/L) 75 or above 50 – 74 Less than 50 or signs of active haemorrhage 2nd Occurrence Delay until neutrophils are 1x109/L or above and then give 50% of the original dose plus prophylactic growth factors 1st Occurrence Delay until the neutrophils are 1x109/L or above and then give 75% of the original dose plus prophylactic growth factors 2nd Occurrence Delay until the neutrophils are 1x109/L or above and then give 50% of the original dose plus prophylactic growth factors Dose Modifications (cyclophosphamide and etoposide) 100% 1st Occurrence Give 75% of the dose 2nd Occurrence Give 50% of the dose 1st Occurence Delay until the platelets are 75 or above then give 75% of the original dose 2nd Occurrence Delay until the platelets are 75 or above then give 50% of the original dose Version 1.2 (Jan 2015) Page 2 of 11 Lymphoma- RCEOP-Cyclophosphamide-Etoposide-Prednisolone-Rituximab-Vincristine Hepatic Impairment Please note that the approach may be different where abnormal liver function tests are due to disease involvement. Drug Cyclophosphamide Bilirubin (μmol/L) AST/ALT (units/L) Dose (%of original dose) Evidence suggests no dose adjustment needed. Etoposide *30-51 Or more than 51 Or 60-180 More than180 Consider dose reducing to 50% Clinical decision Rituximab N/A N/A No dose adjustment needed *30-51 Or 60-180 50% Vincristine more than 51 And normal 50% more than 51 And more than 180 omit * The lower limit reflects local practice and may differ from published sources. Renal Impairment Drug Cyclophosphamide* Creatinine Clearance (ml/min) more than 20 10-20 less than10 Dose (% of original dose) 100% 75% 50% Etoposide more than 50 15-50 Less than15 100% 75% 50% Rituximab N/A No dose adjustment needed Vincristine N/A No dose adjustment needed *Consider mesna in patients with pre-existing bladder disorders. Give an oral dose of 40% of the cyclophosphamide dose (rounded upwards to the nearest 400mg) at 0, 2 and 6 hours after the administration of the cyclophosphamide. Version 1.2 (Jan 2015) Page 3 of 11 Lymphoma- RCEOP-Cyclophosphamide-Etoposide-Prednisolone-Rituximab-Vincristine 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. Etoposide Where significant reductions in albumin levels occur consider reducing the dose of etoposide. Rituximab Infusion related adverse reactions have been observed in 10% of patients treated with rituximab. Rituximab administration is associated with the onset of cytokine release syndrome. This condition is characterised by severe dyspnoea, often accompanied by bronchospasm and hypoxia, in addition to fever, chills, rigors, urticaria, and angioedema. It may be associated with some features of tumour lysis syndrome such as hyperuricaemia, hyperkalaemia, hypocalcaemia, acute renal failure, elevated lactate dehydrogenase (LDH) and can lead to acute respiratory failure and death. This effect on the lungs may be accompanied by events such as pulmonary interstitial infiltration or oedema, visible on a chest x-ray. Cytokine release syndrome frequently occurs within one or two hours of initiating the first infusion. Hypersensitivity reactions, including anaphylaxis, have been reported following the intravenous administration of proteins. In contrast to cytokine release syndrome, true hypersensitivity reactions typically occur within minutes of starting the infusion. Medicinal products for the treatment of allergic reactions should be available for immediate use in the event of hypersensitivity developing during the administration of rituximab. Use of rituximab maybe associated with an increased risk of progressive multifocal leukoencephalopathy (PML). Patients must be monitored at regular intervals for any new or worsening neurological, cognitive or psychiatric symptoms that may be suggestive of PML. If PML is suspected, further dosing must be suspended until PML has been excluded. If PML is confirmed the rituximab must be permanently discontinued. The presence of a viral upper respiratory tract infection at the time of treatment may increase the risk of rituximab associated hepatotoxicity. Patients should be assessed for any cold or flu-like symptoms prior to treatment. Vincristine Reduce the vincristine dose to 1mg if a NCI-CTC grade 2 motor or grade 3 sensory neurological toxicity occurs. For higher toxicity grades or if toxicity increases despite dose reduction stop the vincristine. Version 1.2 (Jan 2015) Page 4 of 11 Lymphoma- RCEOP-Cyclophosphamide-Etoposide-Prednisolone-Rituximab-Vincristine Regimen 21 day cycle for 6 cycles Drug Cyclophosphamide Etoposide Rituximab Vincristine Etoposide Prednisolone Dose 750mg/m2 150mg/m2 375mg/m2 1.4mg/m2 (max 2mg) 100mg/m2 100mg Days Administration 1 Intravenous bolus over 10 minutes Intravenous infusion in 1000ml 1 sodium chloride 0.9% over 60 minutes 1 Intravenous infusion in 500ml sodium chloride 0.9% 1 Intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes 2 and 3 Oral 1, 2, 3, 4, 5 Oral Consider initial dose reduction in patients over 70 years of age. Doses may be escalated up to full dose on subsequent cycles according to tolerability. Dose Information Cyclophosphamide will be dose banded according to the CSCCN agreed bands Etoposide (intravenous) will be dose banded according to the CSCCN agreed bands Etoposide (oral) is available as 50mg and 100mg capsules. All doses will be rounded to the nearest 50mg (up if halfway) Rituximab will be rounded banded to the nearest 100mg (up if halfway) Vincristine dose will be rounded to the nearest 0.1mg (up if halfway) The maximum dose of vincristine is 2mg Administration Information Extravasation Cyclophosphamide – neutral Etoposide – irritant Rituximab - neutral Vincristine - vesicant Version 1.2 (Jan 2015) Page 5 of 11 Lymphoma- RCEOP-Cyclophosphamide-Etoposide-Prednisolone-Rituximab-Vincristine Other Etoposide (oral) should be taken an hour before food or on an empty stomach Prednisolone should be taken in the morning with or after food. Administration of prednisolone begins on the morning of chemotherapy. The rate of administration of rituximab varies. Please refer to the rituximab administration guidelines. Additional Therapy Antiemetics 15-30 minutes prior to chemotherapy - ondansetron 8mg oral or intravenous As take home medication - metoclopramide 10mg three times a day when required oral - ondansetron 8mg twice a day for 3 days oral Rituximab pre-medication 30 minutes prior to rituximab - chlorphenamine 10mg intravenous - paracetamol 1000mg oral On the morning of treatment - prednisolone 100mg oral to be self administered by the patient on the morning of treatment and for four days after rituximab treatment (this is part of the chemotherapy schedule as well as rituximab pre-medication) Version 1.2 (Jan 2015) Page 6 of 11 Lymphoma- RCEOP-Cyclophosphamide-Etoposide-Prednisolone-Rituximab-Vincristine Rituximab infusion reactions - hydrocortisone 100mg intravenous when required for rituximab infusion related reactions - salbutamol 2.5mg nebule when required for rituximab related bronchospasm - consider pethidine 25-50mg intravenous for rituximab related rigors that fail to respond to steroids. Allopurinol 300mg once a day oral for the first cycle only Consider anti-infective prophylaxis in high risk patients, including: - aciclovir 400mg twice a day oral - co-trimoxazole 960mg once a day oral on Monday, Wednesday and Friday only oral Mouthwashes according to local or national policy on the treatment of mucositis 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 Agency alert NPSA/2008/RRR001 must be followed when prescribing, dispensing or administering oral chemotherapy. It must be made clear to all staff, including those in the community, that this is a short course of oral chemotherapy that must not be continued. Patients should be assessed for suitability for oral chemotherapy prior to starting treatment. The National Patient Safety Agency report NPSA/2008/RRR04 must be followed in relation to intravenous administration of vinca alkaloids. Coding (OPCS 4.6) Procurement – X71.3 Delivery – X72.1 Version 1.2 (Jan 2015) Page 7 of 11 Lymphoma- RCEOP-Cyclophosphamide-Etoposide-Prednisolone-Rituximab-Vincristine REGIMEN SUMMARY RCEOP-Cyclophosphamide-Etoposide-Prednisolone-Rituximab-Vincristine Cycle 1 1. Warning – Check patient has taken the prednisolone dose* 2. Chlorphenamine 10mg intravenous 3. Paracetamol 1000mg oral 4. Rituximab 375mg/m2 intravenous infusion in 500ml sodium chloride 0.9% as per the rituximab administration guidelines 5. Ondansetron 8mg oral or intravenous injection 6. Vincristine 1.4mg/m2 (max 2mg) intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes 7. Etoposide 150mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% over 60 minutes 8. Cyclophosphamide 750mg/m2 intravenous bolus over 10 minutes 9. Hydrocortisone 100mg intravenous once only when required for the relief of rituximab infusion related reactions 10. Salbutamol 2.5mg nebule once only when required for the relief of rituximab related bronchospasm Take Home Medicines 11. Etoposide 100mg/m2 once a day for 2 days oral (starting on day 2) 12. Prednisolone 100mg once a day on the morning of the next treatment** 13. Prednisolone 100mg once a day for 4 days oral (starting on day 2)** 14. Metoclopramide 10mg three times a day when required oral 15. Ondansetron 8mg twice a day for 3 days oral starting on the evening of day one of treatment 16. Allopurinol 300mg once a day oral for 21 days Cycles 2, 3, 4 and 5 1. Warning – Check patient has taken the prednisolone dose* 2. Chlorphenamine 10mg intravenous Version 1.2 (Jan 2015) Page 8 of 11 Lymphoma- RCEOP-Cyclophosphamide-Etoposide-Prednisolone-Rituximab-Vincristine 3. Paracetamol 1000mg oral 4. Rituximab 375mg/m2 intravenous infusion in 500ml sodium chloride 0.9% as per the rituximab administration guidelines 5. Ondansetron 8mg oral or intravenous injection 6. Vincristine 1.4mg/m2 (max 2mg) intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes 7. Etoposide 150mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% over 60 minutes 8. Cyclophosphamide 750mg/m2 intravenous bolus over 10 minutes 9. Hydrocortisone 100mg intravenous when required for the relief of rituximab infusion related reactions 10. Salbutamol 2.5mg nebules when required for the relief of rituximab related bronchospasm Take Home Medicines 11. Etoposide 100mg/m2 once a day for 2 days oral (starting on day 2) 12. Prednisolone 100mg once a day on the morning of the next treatment** 13. Prednisolone 100mg once a day for 4 days oral (starting on day 2)** 14. Metoclopramide 10mg three times a day when required oral 15. Ondansetron 8mg twice a day for 3 days oral starting on the evening of day one of treatment Cycle 6 1. Warning – Check patient has taken the prednisolone dose* 2. Chlorphenamine 10mg intravenous 3. Paracetamol 1000mg oral 4. Rituximab 375mg/m2 intravenous infusion in 500ml sodium chloride 0.9% as per the rituximab administration guidelines 5. Ondansetron 8mg oral or intravenous injection 6. Vincristine 1.4mg/m2 (max 2mg) intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes 7. Etoposide 150mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% over 60 minutes Version 1.2 (Jan 2015) Page 9 of 11 Lymphoma- RCEOP-Cyclophosphamide-Etoposide-Prednisolone-Rituximab-Vincristine 8. Cyclophosphamide 750mg/m2 intravenous bolus over 10 minutes 9. Hydrocortisone 100mg intravenous when required for the relief of rituximab infusion related reactions 10. Salbutamol 2.5mg nebules when required for the relief of rituximab related bronchospasm Take Home Medicines 11. Etoposide 100mg/m2 once a day for 2 days oral (starting on day 2) 12. Prednisolone 100mg once a day for 4 days oral (starting on day 2) 13. Metoclopramide 10mg three times a day when required oral 14. Ondansetron 8mg twice a day for 3 days oral starting on the evening of day one of treatment Administration information * Please check the patient has taken prednisolone 100mg oral on the morning of rituximab administration. On occasions where individuals attend for treatment and have forgotten to take the prednisolone dose please administer prednisolone 100mg oral 30 minutes prior to rituximab administration. **The prednisolone may be dispensed as a single supply in one container or as two containers depending on local preference Version 1.2 (Jan 2015) Page 10 of 11 Lymphoma- RCEOP-Cyclophosphamide-Etoposide-Prednisolone-Rituximab-Vincristine DOCUMENT CONTROL Version Date Amendment Written By Approved By Header changed Toxicities removed Hepatic & renal tables updated Metoclopramide dose changed to 10mg Donna Kimber 1.2 Jan 2015 Bolus removed from intravenous Pharmacy bolus throughout text Technician Mucositis recommendation changed Disclaimer added Document control reordered “In patients over 70 years of age consider using vincristine 1mg. Where 1.1 July 2012 appropriate dose reduction of other agents may be considered at cycle one” changed to “Consider initial dose Rebecca Wills Pharmacist reduction in patients over 70 years of age.” 1 April 2012 None Rebecca Wills Pharmacist Dr Debbie Wright Pharmacist Rebecca Wills Pharmacist Dr Debbie Wright Pharmacist Dr Andrew Davies Consultant Medical Oncologist Dr Alison Milne 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 Hospitals 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 which occur as a result of following these guidelines. Version 1.2 (Jan 2015) Page 11 of 11 Lymphoma- RCEOP-Cyclophosphamide-Etoposide-Prednisolone-Rituximab-Vincristine
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O-CVP-Cyclophosphamide-Obinutuzumab-Prednisolone-Vincristine

Description: Chemotherapy Protocol Non-Hodgkin Lymphoma Cyclophosphamide-Obinutuzumab-Prednisolone-Vincristine Regimen (O-CVP) • NHL – O-CVP-Cyclophosphamide-Obinutuzumab-Prednisolone-Vincristine Indication • Obinutuzumab in combination with cyclophosphamide, prednisolone and vincristine (CVP) followed by obinutuzumab maintenance is recommended as an option for treating adults with untreated advanced follicular lymphoma (that is, first as induction treatment with chemotherapy than as maintenance therapy) provided the person has a Follicular Lymphoma International Prognostic Index (FLIPI) score of 2 or more • WHO Performance Status 0, 1, 2 Toxicity Drug Cyclophosphamide Obinutuzumab Prednisolone Vincristine Adverse Effect Dysuria, haemorrhagic cystitis (rare), taste disturbances Infusion related reactions, progressive multifocal leukoencephalopathy (PML), cardiac toxicity, thrombocytopenia, neutropenia, tumour lysis syndrome Weight gain, gastro-intestinal disturbances, hyperglycaemia, CNS disturbances, cushingoid changes, glucose intolerance Peripheral neuropathy, constipation, jaw pain 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 one of the first six cycles, optional on days eight and fifteen of the first cycle • Consider uric acid and bone profile prior to cycle one in those considered at risk of tumour lysis syndrome 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 Version 1 (June 2018) Page 1 of 15 NHL-O-CVP-Cyclophosphamide-Obinutuzumab-Prednisolone-Vincristine 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 (80mg/L). 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. There are no dose reductions for obinutuzumab based on haematological parameters. Neutrophils (x109/L) Less than 1 on proposed day 1 of cycle (unless considered disease-related) Grade 4 neutropenia or any febrile neutropenia following any cycle Grade 4 neutropenia leading to infection despite G-CSF support Grade 4 neutropenia recurs despite 50% dose reduction in cyclophosphamide and doxorubicin Platelets (x109/L) Less than 100 on proposed day 1 of cycle (unless considered disease-related) Grade 4 thrombocytopenia following any cycle Grade 4 thrombocytopenia recurs despite 50% dose reduction in cyclophosphamide and doxorubicin Dose Modifications (cyclophosphamide and doxorubicin) Delay therapy until neutrophils are greater than or equal to 1x109/L. Consider growth factors as secondary prophylaxis. Reconsider treatment options if not recovered after 14 days. Give growth factors with all subsequent cycles Reduce dose of cyclophosphamide and doxorubicin by 50% for all subsequent cycles Stop treatment Dose Modifications (cyclophosphamide and doxorubicin) Delay therapy until platelets are greater or equal to 100x109/L. Reconsider treatment options if not recovered after 14 days. Reduce dose of cyclophosphamide and doxorubicin by 50% for all subsequent cycles Stop treatment 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. Version 1 (June 2018) Page 2 of 15 NHL-O-CVP-Cyclophosphamide-Obinutuzumab-Prednisolone-Vincristine Please note that the approach may be different where abnormal liver function tests are due to disease involvement. Drug Cyclophosphamide Bilirubin (µmol/L) AST/ALT (units/L) Dose (%of original dose) Evidence suggests dose modification not necessary. *30-51 or 60-180 50% Vincristine more than 51 and normal 50% more than 51 and more than 180 omit * Lower limit reflects local practice and may differ from published sources. Renal Impairment Drug Cyclophosphamide** Creatinine Clearance (ml/min) more than 20 10-20 less than 10 Dose (% of original dose) 100% 75% 50% Vincristine N/A No dose adjustment needed **Consider mesna in patients with pre-existing bladder disorders. Give an oral dose of 40% of the cyclophosphamide dose (rounded upwards to the nearest 400mg) at 0, 2 and 6 hours after the administration of the cyclophosphamide. Dose adjustment is not considered necessary for obinutuzumab in those with mild to moderate renal impairment. Patients with evidence of impaired renal function should be carefully monitored as they are prone to additional myelosuppression. 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. In general for all other non-haematological NCI-CTC grade 3 and above toxicities delay treatment until the adverse effect has resolved to NCI-CTC grade 2 or below. The dose should then be reduced to 75% of the original dose. If toxicity recurs delay until recovery and further dose reduce to 50% of the original dose or discontinue as appropriate. Version 1 (June 2018) Page 3 of 15 NHL-O-CVP-Cyclophosphamide-Obinutuzumab-Prednisolone-Vincristine Obinutuzumab 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 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. Patients with a high tumour burden and / or high circulating lymphocyte count (greater than 25x109/L may be at increased risk of severe infusion related reactions (this has been particularly noted in the CLL setting). 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. 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. Version 1 (June 2018) Page 4 of 15 NHL-O-CVP-Cyclophosphamide-Obinutuzumab-Prednisolone-Vincristine 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 Hold infusion and treat the symptoms. Restart the infusion once the First episode of grade 3 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 Infusion must be stopped and therapy must be permanently discontinued reactions Tumour Lysis Syndrome (TLS) Tumour lysis syndrome (TLS) has been reported with obinutuzumab. 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 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 British Society of Haematology guidelines. For treatment of TLS, correct electrolyte abnormalities, monitor renal function and fluid balance, and administer supportive care, including dialysis as indicated. Vincristine Reduce the vincristine dose to 1mg if an NCI-CTC grade 2 motor or grade 3 sensory neurological toxicity occurs. For higher toxicity grades or if toxicity increases despite dose reduction stop the vincristine. Version 1 (June 2018) Page 5 of 15 NHL-O-CVP-Cyclophosphamide-Obinutuzumab-Prednisolone-Vincristine Regimen 21 day cycle for 8 cycles (induction therapy) Cycle 1 Drug Dose Cyclophosphamide 750mg/m2 Obinutuzumab 1000mg Vincristine 1.4mg/m2 (max 2mg) Days 1 1, 8, 15 1 Administration Intravenous bolus over 10 minutes Intravenous infusion in 250ml sodium chloride 0.9% (see administration information for the rate of administration Intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes Prednisolone* 100mg 2, 3, 4, 5 Oral Methylprednisolone is given as obinutuzumab pre-medication on day 1 Cycle 2, 3, 4, 5, 6 Drug Dose Cyclophosphamide 750mg/m2 Obinutuzumab 1000mg Vincristine 1.4mg/m2 (max 2mg) Days 1 1 1 Administration Intravenous bolus over 10 minutes Intravenous infusion in 250ml sodium chloride 0.9% (see administration information for the rate of administration Intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes Prednisolone* 100mg 2, 3, 4, 5 Oral Methylprednisolone is given as obinutuzumab pre-medication on day 1 Cycles 7, 8 Drug Obinutuzumab Dose 1000mg Days 1 Administration Intravenous infusion in 250ml sodium chloride 0.9% (see administration information for the rate of administration This is followed by maintenance treatment. The maintenance obinutuzumab will set as a separate protocol in ARIA. Version 1 (June 2018) Page 6 of 15 NHL-O-CVP-Cyclophosphamide-Obinutuzumab-Prednisolone-Vincristine Cycle 9 – 20 inclusive (1-12 inclusive in ARIA-maintenance therapy) 56 Day Cycle This will be set as a separate regimen in ARIA Drug Obinutuzumab Dose 1000mg Days 1 Administration Intravenous infusion in 250ml sodium chloride 0.9% (see administration information for the rate of administration *Please see administration information below for infusion rates Dose Information • Cyclophosphamide will be dose banded according to the national dose bands (20PM) • Vincristine dose will be dose banded according to the national dose bands (1mg/ml) • The maximum dose of vincristine is 2mg Administration Information Extravasation • Cyclophosphamide – neutral • Obinutuzumab – non-vesicant • Vincristine - vesicant Other Obinutuzumab standard infusion rates, in the absence of reactions are as follows; Cycle Day of Treatment Rate of Infusion (Obinutuzumab) Start the administration at 50mg/hour 1 Day 1 The rate of the infusion can be escalated in increments of 50mg/hour every 30 minutes to a maximum rate of 400mg/hour 1 8, 15 If an infusion related reaction at Grade 1 or below occurred during the previous infusion when the final infusion rate was 100mg/hr or faster, infusions can be started at a rate of 100 mg/hr and increased by 100 mg/hr increments every 30 minutes to a maximum of 400 mg/hr. 2 All days If the patient experienced an infusion related reaction of Grade 2 or higher during the previous infusion administer at 50mg/hr. The rate of infusion can be escalated in 50mg/hr increments every 30 minutes to a maximum of 400mg/hr. Version 1 (June 2018) Page 7 of 15 NHL-O-CVP-Cyclophosphamide-Obinutuzumab-Prednisolone-Vincristine Additional Treatment • Antiemetics 15-30 minutes prior to CVP on day 1 - ondansetron 8mg oral or intravenous As take home medication on day 1 - metoclopramide 10mg three times a day when required oral • Premedication for obinutuzumab infusion reactions - sodium chloride 0.9% 500ml intravenous infusion over 60 minutes then as follows; Cycle 1 day 1 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 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 Methylprednisolone sodium succinate √ √ 80mg intravenous Chlorphenamine √ 10mg intravenous √ √ Paracetamol 1000mg oral √ √ √ √ 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 - pethidine 25mg intravenous in 10ml sodium chloride 0.9% over 5 minutes for rigors following a verbal confirmation to administer from a doctor. • Patients at high risk of tumour lysis syndrome (TLS) should be started on allopurinol 300mg once a day for 7 days. Allopurinol should not be used where the risk of TLS is deemed low. Very high risk patients may require Version 1 (June 2018) Page 8 of 15 NHL-O-CVP-Cyclophosphamide-Obinutuzumab-Prednisolone-Vincristine rasburicase. • Consider anti-infective prophylaxis in high risk patients, including: - aciclovir 400mg twice a day oral - co-trimoxazole 960mg once a day oral on Monday, Wednesday and Friday only • Mouthwashes according to local or national policy on the treatment of mucositis • 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 • 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 • The National Patient Safety Agency report NPSA/2008/RRR04 must be followed in relation to intravenous administration of vinca alkaloids. Coding • Procurement – X70.8 • Delivery – X72.9 References 1. National Institute for Health and Clinical Excellence (2018). Technical Appraisal Guidance (TA 513). Obinutuzumab for untreated advanced follicular lymphoma. NICE:DOH Version 1 (June 2018) Page 9 of 15 NHL-O-CVP-Cyclophosphamide-Obinutuzumab-Prednisolone-Vincristine REGIMEN SUMMARY O-CVP-Cyclophosphamide-Obinutuzumab-Prednisolone-Vincristine Cycle 1 Day One 1. Sodium chloride 0.9% 500ml intravenous infusion over 60 minutes 2. Chlorphenamine 10mg intravenous Administration Instructions Administer 60 minutes prior to obinutuzumab 3. Methylprednisolone sodium succinate 80mg intravenous Administration Instructions Administer 60 minutes prior to obinutuzumab 4. 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 5. 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. 6. Ondansetron 8mg oral or intravenous 7. Vincristine 1.4mg/m2 (max 2mg) intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes 8. Cyclophosphamide 750mg/m2 intravenous bolus over 10 minutes 9. Chlorphenamine 10mg when required for infusion related reactions Administration Instructions For the relief of infusion related reactions 10. Lorazepam 1mg oral when required for rigors Administration Instructions For the relief of rigors 11. Methylprednisolone sodium succinate 80mg intravenous bolus when required for the relief of infusion related reactions Administration Instructions For the relief of infusion related reactions 12. 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 13. 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 (June 2018) Page 10 of 15 NHL-O-CVP-Cyclophosphamide-Obinutuzumab-Prednisolone-Vincristine Take home medicines (day 1 only) 14. Prednisolone 100mg once a day in the morning for four days oral Administration Instructions Take 100mg each morning on days 2, 3, 4, 5 of the cycle Take with or after food 15. Metoclopramide 10mg three times a day when required oral Administration Instructions Please supply 28 tablets or an original pack as appropriate 16. Ondansetron 8mg twice a day oral for 3 days starting on the evening of day one of treatment Administration Instructions To start on the evening of day one of the cycle 17. Allopurinol 300mg once a day for 7 days Administration Instructions Please refer to the protocol for recommendations on the prevention and treatment of tumour lysis syndrome. Individuals at high risk may require rasburicase. Cycle 1 Day Eight and Fifteen 18. Sodium chloride 0.9% 500ml intravenous infusion over 60 minutes 19. Chlorphenamine 10mg intravenous Administration Instructions Administer 60 minutes prior to obinutuzumab 20. Methylprednisolone sodium succinate 80mg intravenous Administration Instructions Administer 60 minutes prior to obinutuzumab 21. 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 22. 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. 23. Chlorphenamine 10mg when required for infusion related reactions Administration Instructions For the relief of infusion related reactions 24. Lorazepam 1mg oral when required for rigors Administration Instructions For the relief of rigors 25. Methylprednisolone sodium succinate 80mg intravenous bolus when required for the relief of infusion related reactions Administration Instructions For the relief of infusion related reactions 26. 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 Version 1 (June 2018) Page 11 of 15 NHL-O-CVP-Cyclophosphamide-Obinutuzumab-Prednisolone-Vincristine 27. 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 Cycle 2, 3, 4, 5, 6 Day One 28. Sodium chloride 0.9% 500ml intravenous infusion over 60 minutes 29. Chlorphenamine 10mg intravenous Administration Instructions Administer 60 minutes prior to obinutuzumab 30. Methylprednisolone sodium succinate 80mg intravenous Administration Instructions Administer 60 minutes prior to obinutuzumab 31. 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 32. 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. 33. Ondansetron 8mg oral or intravenous 34. Vincristine 1.4mg/m2 (max 2mg) intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes 35. Cyclophosphamide 750mg/m2 intravenous bolus over 10 minutes 36. Chlorphenamine 10mg when required for infusion related reactions Administration Instructions For the relief of infusion related reactions 37. Lorazepam 1mg oral when required for rigors Administration Instructions For the relief of rigors 38. Methylprednisolone sodium succinate 80mg intravenous bolus when required for the relief of infusion related reactions Administration Instructions For the relief of infusion related reactions 39. 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 40. 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 (June 2018) Page 12 of 15 NHL-O-CVP-Cyclophosphamide-Obinutuzumab-Prednisolone-Vincristine Take home medicines (day 1 only) 41. Prednisolone 100mg once a day in the morning for four days oral Administration Instructions Take 100mg each morning on days 2, 3, 4, 5 of the cycle Take with or after food 42. Metoclopramide 10mg three times a day when required oral Administration Instructions Please supply 28 tablets or an original pack as appropriate 43. Ondansetron 8mg twice a day oral for 3 days starting on the evening of day one of treatment Administration Instructions To start on the evening of day one of the cycle Cycle 7, 8 Day One 44. Warning – Consider Maintenance Administration Instructions Please consider if patients require maintenance obinutuzumab. This is a separate protocol on ARIA. 45. Sodium chloride 0.9% 500ml intravenous infusion over 60 minutes 46. Chlorphenamine 10mg intravenous Administration Instructions Administer 60 minutes prior to obinutuzumab 47. Methylprednisolone sodium succinate 80mg intravenous Administration Instructions Administer 60 minutes prior to obinutuzumab 48. 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 49. 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. 50. Chlorphenamine 10mg when required for infusion related reactions Administration Instructions For the relief of infusion related reactions 51. Lorazepam 1mg oral when required for rigors Administration Instructions For the relief of rigors 52. Methylprednisolone sodium succinate 80mg intravenous bolus when required for the relief of infusion related reactions Administration Instructions For the relief of infusion related reactions 53. 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 54. Pethidine 25mg intravenous bolus in 10ml sodium chloride 0.9% over 5 minutes for the relief of rigors Version 1 (June 2018) Page 13 of 15 NHL-O-CVP-Cyclophosphamide-Obinutuzumab-Prednisolone-Vincristine Administration Instructions For the relief of rigors following a verbal confirmation to administer from a doctor Version 1 (June 2018) Page 14 of 15 NHL-O-CVP-Cyclophosphamide-Obinutuzumab-Prednisolone-Vincristine DOCUMENT CONTROL Version Date Amendment Written By Approved By 1 June 2018 None Dr Deborah Wright Pharmacist Dr Rob Lown 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 should be used in conjunction with other references such as the Summary of Product Characteristics and relevant published papers. Version 1 (June 2018) Page 15 of 15 NHL-O-CVP-Cyclophosphamide-Obinutuzumab-Prednisolone-Vincristine
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