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AmB LEAM (split)-Lomustine-Cytarabine-Etoposide-Melphalan

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Chemotherapy Protocol LYMPHOMA LOMUSTINE-CYTARABINE-ETOPOSIDE (split)-MELPHALAN (LEAM) Ambulatory Regimen This regimen is for AMBULATORY CARE pathway use only and will only be available to prescribe at units which carry out autograft transplantation. Regimen Lymphoma – AmB-LEAM (split)-Lomustine-Cytarabine-Etoposide-Melphalan Indication • Conditioning for autologous peripheral blood stem cell transplant (PBSCT) / bone marrow transplant in individuals with either Non Hodgkin Lymphoma (NHL) or Hodgkin Lymphoma Toxicity Drug Lomustine Cytarabine Etoposide Adverse Effect Pulmonary toxicity CNS toxicity, conjunctivitis, flu-like syndrome, pulmonary toxicity, gastro-intestinal toxicity Hypotension on rapid infusion, hyperbilirubinaemia Melphalan Gastro-intestinal disturbances, stomatitis Patients treated with LEAM are at risk of transfusion-associated graft versus host disease (TA-GVHD). Where blood products are required these patients must receive irradiated blood products for the 1 week prior to harvest and for at least 12 weeks after the transplant has taken place. Patients with Hodgkin lymphoma carry a lifelong risk of graft versus host disease and must always receive irradiated blood products. Local blood transfusion departments must be notified as soon as a diagnosis is made and the patient must be issued with an alert card to carry with them at all times. The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Version 1 (August 2023) Page 1 of 12 Lymphoma- AmB-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan Monitoring Drugs • FBC, LFTs (including albumin) and U&Es prior to day one of treatment • EDTA or calculated creatinine clearance prior to each melphalan infusion • Monitor the fluid balance during the administration of melphalan, including throughout the administration of the pre and post hydration. Ensure the urine output is more than 250ml/hour immediately prior to the administration of melphalan Dose Modifications The dose modifications listed are for haematological, liver and renal function and some limited 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. 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 Treatment will be given regardless of blood results. Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Irradiated blood products must be used. Hepatic Impairment Please note that the approach may be different if abnormal liver function tests are due to disease involvement. Drug Lomustine Bilirubin μmol/L N/A AST/ALT units/L N/A Dose (% of original dose) No dose adjustment necessary Cytarabine more than 34 50% The dose may be escalated dependent on toxicity Etoposide Melphalan 30-51 or 60-180 more than 51 or more than 180 N/A N/A Consider dose reducing to 50% Clinical decision No dose adjustment necessary Version 1 (August 2023) Page 2 of 12 Lymphoma- AmB-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan Renal Impairment Drug Lomustine Creatinine Clearance (ml/min) more 60 45-60 30-<45 less than 30 Dose (% of original dose) 100% 75% 50% Clinical decision Cytarabine N/A No dose adjustment necessary Etoposide more than 50 15-50 less than 15 100% 75% 50% Melphalan more than 50 30-50 less than 30 100% 75% Clinical decision Other Lomustine It may be necessary to reduce the dose of lomustine in patients with reduced pulmonary function. Lomustine dose reductions in this situation are to be made at the discretion of the consultant oncologist/haematologist only. Etoposide Where significant reductions in albumin levels occur consider reducing the dose of etoposide. Regimen 1 cycle will be set in Aria Drug Lomustine Cytarabine Etoposide Dose 200mg/m2 1600 mg/m2 (8 doses of 200mg/m2 every 12 hours) 200mg/m2 Days -6 200mg/m2 BD Every 12 hours at 9am and 9pm. -5,-4,-3,-2 (8 doses total) -5,-4,-3,-2 Administration Oral Administer via CADD Solis VIP pump. Each CADD cassette contains 8 doses (240ml total volume). Connect cassette on day -5 and disconnect on day -1 (AM) Each dose: IV infusion of 200mg/m2 in 30ml of sodium chloride 0.9% over 15 minutes at 120ml/hr. Intravenous infusion in 2000ml sodium chloride 0.9% over 120 minutes (this will be administered as two infusions of 100mg/m2 in 1000ml sodium chloride 0.9% over 60 minutes administered Version 1 (August 2023) Page 3 of 12 Lymphoma- AmB-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan Melphalan 140mg/m2 sequentially) -1 Intravenous infusion in 500ml sodium chloride 0.9% over 30 minutes Dose Information • Lomustine will be dose rounded to the nearest 40mg (down if halfway) • Cytarabine will be dose banded in accordance with the national dose bands (100mg/ml) • Etoposide will be dose banded in accordance with the national dose bands (20mg/ml) • The melphalan dose will be dose rounded to the nearest 10mg (down if halfway). The National Dose Banding Team have advised not to use dose banding tables for this product in view of the 90 minute expiry (must be made locally for individual patient), the 50mg vial size and frequent stock shortages. Administration Information CADD pump • Total 8 doses provided as one infusion bag in cassette of CADD pump, to be administered as intermittent infusion on day -5 to -2. • Sodium chloride 0.9% 100ml to be run as continuous infusion to keep CADD infusion line patent. • Administer concurrently with cytarabine via Y-site with at 0.5 mL/hour on days -5 to 1. Extravasation • Cytarabine – non-vesicant • Etoposide – irritant • Melphalan – irritant Other • Due to the stability of etoposide the total dose of 200mg/m2 will be split into two infusions of 100mg/m2 in 1000ml sodium chloride 0.9% over 60 minutes. The two infusions are given sequentially, the second is started as soon as the first infusion is complete. The total duration of etoposide administration is 120minutes. • Ensure the urine output is more than 250ml/hour immediately prior to the administration of melphalan Version 1 (August 2023) Page 4 of 12 Lymphoma- AmB-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan Additional Therapy This regimen is to be administered in the ambulatory setting. Please ensure all supportive and take home medicines are prescribed on the in-patient chart or general electronic prescribing system on admission. Please refer to the transplant schedule for each individual patient. • Antiemetics Starting 15-30 minutes prior to chemotherapy - dexamethasone 2mg twice a day for 10 days oral or intravenous starting on day -6 of the cycle - metoclopramide 10mg three times a day for 10 days oral or intravenous starting on day -6 of the cycle - ondansetron 8mg twice a day for 10 days oral or intravenous - aprepitant 125mg once only orally on the day of the melphalan infusion then 80mg once a day for the subsequent two days • Anti-infectives - aciclovir 400mg oral twice a day until day +180 - ciprofloxacin 250mg oral twice a day from day+1 (stop when neutrophils are greater than 1) - pentamidine 300mg by nebuliser prior to discharge - co-trimoxazole 960mg once a day on Monday, Wednesday and Friday (start from 28 days post discharge, if neutrophils are greater than 1 and platelets are greater than 50, and continue until day +180) - fluconazole 100mg once a day oral (stop when neutrophils are greater than 1 unless the patient remains on corticosteroids) - nystatin suspension 1ml four times a day oral (stop when neutrophils are greater than 1 unless the patient remains on corticosteroids) • Thromboprophylaxis, continued until platelets are less than 50x109/L, or as directed by the consultant, according to local formulary choices; - dalteparin 5000units once a day subcutaneous injection - enoxaparin 40mg once a day subcutaneous injection - heparin 5000units twice a day subcutaneous injection • Growth factors such as filgrastim biosimilar 30million units (300mcg) once a day subcutaneous from day +5 (stop when neutrophils are greater than 1x109/L for at least 24 hours, or greater than 3 on any occasion) • Hormone replacement In menstruating women consider norethisterone 5mg three times a day oral to prevent menstruation. This may be stopped when the platelets are more than 50x109/L. • Mouthcare Commence oral cryotherapy approximately 15mins prior to melphalan infusion, replenishing to cover melphalan infusion and 75 mins afterwards. Version 1 (August 2023) Page 5 of 12 Lymphoma- AmB-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan Mouthcare for the prophylaxis or treatment of mucositis in accordance with local or national guidelines. • Gastric protection with a proton pump inhibitor or a H2 antagonist according to local formulary choice; - esomeprazole 20mg once a day oral - omeprazole 20mg once a day oral - lansoprazole 15mg once a day oral - pantoprazole 20mg once a day oral - rabeprazole 20mg once a day oral - cimetidine 400mg twice a day oral - famotidine 20mg once a day oral - nizatidine 150mg twice a day oral - ranitidine 150mg twice a day oral • Hydration - Encourage 3L oral fluids daily. If ambulatory patients are unable to maintain this (e.g. due to nausea), they should be admitted for intravenous hydration. - Intravenous hydration before and after melphalan infusion should be prescribed on inpatient prescribing system or using paper proforma (Appendix 1) Before and after melphalan infusion - Encourage oral hydration at least 1 litre between 8pm and 8am the night before melphalan infusion. 0830hrs Contact pharmacy on ext 5037 to inform them that the patient is present. Confirm that they have melphalan prescription (on ARIA). Request melphalan infusion to be on the ward by 11:30hrs. Start fluid chart and daily weights. Start fluid 1000ml sodium chloride 0.9% intravenous infusion over 90 minutes 0915hrs Administer anti-emetics and supportive medication as per ARIA prescription 0930hrs 20mg furosemide intravenous bolus Warning – Check hydration and fluid balance 1000hrs 1000ml sodium chloride 0.9% intravenous infusion over 90 minutes 1030hrs 20mg furosemide intravenous bolus Measure urine output since 0900hrs - If more than 500ml continue with melphalan infusion - If less than 500ml give second furosemide 20mg dose Version 1 (August 2023) Page 6 of 12 Lymphoma- AmB-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan 1130hrs 1200hrs Thereafter intravenous bolus check urine output since 0900hrs again at 1100hrs: o if more than 500ml go ahead with melphalan o if less than 500ml contact the prescriber. Give melphalan intravenous infusion over thirty minutes (This product has a short expiry so adhering to set timing is essential) 1000ml sodium chloride 0.9% intravenous infusion over 120 minutes Encourage 2L oral fluid intake over subsequent 12 hours Instruct patient to take all supportive medications with particular reference to antiemetics Advise patient to drink 1000 ml of oral fluids over the evening Emergency contact details for AOS given to patient Patient and carer to return to C7 at 08:30 on day 0 • The day after melphalan infusion (Day 0): 0830hrs - 1000ml sodium chloride 0.9% intravenous infusion over 480 minutes then restart routine intravenous fluids Additional Information • Irradiated blood products must be used • Autologous stem cells/ bone marrow will be infused on day 0, at least 24 hours after the melphalan infusion References 1.Mills W, Chopra R, McMillan A et al. BEAM chemotherapy and autologous bone marrow transplantation for patients with relapsed or refractory non-Hodgkin's lymphoma. J Clin Oncol (1995);13(3): 588-95 2.Kelsey P, Pearce R, Perry J et al. Substituting carmustine for lomustine is safe and effective in the treatment of relapsed or refractory Lymphoma – a retrospective study from the BSBMT (BEAM versus LEAM) 3. Stabilis (manufacturers data) Stability of Alexan "Ebewe" infusion solutions. Ebewe Pharma 2007 from http://www.stabilis.org/ (Date accessed: 03/07/23). Version 1 (August 2023) Page 7 of 12 Lymphoma- AmB-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan REGIMEN SUMMARY AmB-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan Other than those listed below, supportive medication for this regimen will not appear in Aria as prescribed agents. The administration instructions for each warning describes the agents which must be prescribed on the in-patient chart or general electronic prescribing system. Supportive care should be prescribed on ARIA and given to the patient on day -6. Supportive care should be transcribed to the electronic inpatient prescribing system on admission to hospital. Day -6 1. Warning – Check blood transfusion status Administration Instructions Patients treated with LEAM carry a lifelong risk of transfusion associated graft versus host disease. Where blood products are required these patients must receive ONLY IRRADIATED BLOOD PRODUCTS for life. Ensure transfusion departments are notified and the patient has been issued with an alert card to carry with them at all times. 2. Dexamethasone 2mg oral or intravenous 3. Ondansetron 8mg oral or intravenous 4. Metoclopramide 10mg oral or intravenous 5. Lomustine 200mg/m2 once a day for one day oral Administration Instructions This should be given before midday. Swallow whole with a full glass of water. Do not open or chew 6. Warning -Ensure take home medicines are supplied Take home medicines 7. Aprepitant 80mg once a day oral for 2 days starting the day after melphalan (i.e. start day 0). 8. Dexamethasone 2mg once a day in the afternoon for 6 days starting on day -6 the day of lomustine. Then take 2mg twice a day for 4 days. 9. Ondansetron 8mg once a day in the evening for 6 days starting on day -6 the day of lomustine. Then take 8mg twice a day for 4 days. 10. Metoclopramide 10mg twice a day in the afternoon and evening for 6 days starting on day -6 the day of lomustine. Then take 10mg three times a day for 4 days. Administration instructions –Please supply 28 tablets or an original pack as appropriate 11. Aciclovir 400mg three times a day for 28 days Administration Instructions Please supply 28 days or an original pack if appropriate. 12. Ciprofloxacin 250mg twice a day starting on day +1 (2 days after melphalan administration) for 14 days Administration Instructions Please supply 14 days with no stop date 13. Fluconazole 100mg oral once a day for 14 days Administration instructions – please supply 14 days with no stop date Version 1 (August 2023) Page 8 of 12 Lymphoma- AmB-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan 14. Nystatin 1ml four times a day Administration instructions – please supply 1 x OP 15. Gastric Protection Administration Instructions The choice of gastric protection is dependent on local formulary choice and may include; - esomeprazole 20mg once a day oral - omeprazole 20mg once a day oral - lansoprazole 15mg once a day oral - pantoprazole 20mg once a day oral - rabeprazole 20mg once a day oral - cimetidine 400mg twice a day oral - famotidine 20mg once a day oral - nizatidine 150mg twice a day oral - ranitidine 150mg twice a day oral Please supply 28 days or the nearest original pack size. 16. Sodium Chloride 0.9% oral rinse 10mL four times a day Administration instructions – pharmacy please supply 50 x 10mL pods 17. Thromboprophylaxis according to local formulary choice Continued until platelets are less than 50x109/L, or as directed by the consultant, according to local formulary choices: - dalteparin 5000units once a day subcutaneous injection - enoxaparin 40mg once a day subcutaneous injection - heparin 5000units twice a day subcutaneous injection Please supply 28 days or nearest original pack size. Day -5 18. Dexamethasone 2mg oral or intravenous 19. Ondansetron 8mg oral or intravenous 20. Metoclopramide 10mg oral or intravenous 21. Warning – Cytarabine delivered via one CADD. Administration Instructions Cytarabine is administered TWICE a day at 12 hour intervals (0900 and 2100) via CADD pump. Sodium chloride infusion must be administered concurrently. 22. Cytarabine 1600mg/m2 intravenous infusion in 240ml sodium chloride 0.9% as intermittent infusions via CADD pump. Administration Instructions One dose: Cytarabine 200mg/m2 in 30ml sodium chloride 0.9% over 15 minutes at 120ml/hour. Cytarabine is administered TWICE a day at 12 hour intervals (0900 and 2100) on days -5 to -2 (8 doses in total). Connect cassette on day -5 and disconnect on day -1 (AM). 23. Sodium Chloride 0.9% 100ml continuous infusion at 0.5ml/hr. Administration Instructions Sodium chloride 0.9% to be administered via folfusor pump at 0.5ml/hr on Days -5 to -1. To be connected via Y-site with CADD pump to maintain line patency. Disconnect folfusor at the same time as disconnecting CADD cassette 24. Warning – Etoposide is TWO infusions Administration Instructions Due to the stability of etoposide the total dose of 200mg/m2 will be split into two infusions of 100mg/m2 in 1000ml sodium chloride 0.9% over 60 minutes. The two infusions are given sequentially, the second is started as soon as the first infusion is complete. The total duration of etoposide administration is 120minutes. Version 1 (August 2023) Page 9 of 12 Lymphoma- AmB-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan 25. Etoposide 100mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% over 60 minutes Administration Instructions Due to the stability of etoposide the total dose of 200mg/m2 will be split into two infusions of 100mg/m2 in 1000ml sodium chloride 0.9% over 60 minutes. The two infusions are given sequentially, the second is started as soon as the first infusion is complete. The total duration of etoposide administration is 120minutes. 26. Etoposide 100mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% over 60 minutes Administration Instructions Due to the stability of etoposide the total dose of 200mg/m2 will be split into two infusions of 100mg/m2 in 1000ml sodium chloride 0.9% over 60 minutes. The two infusions are given sequentially, the second is started as soon as the first infusion is complete. The total duration of etoposide administration is 120minutes Day -4, Day -3, Day -2 27. Dexamethasone 2mg oral or intravenous 28. Ondansetron 8mg oral or intravenous 29. Metoclopramide 10mg oral or intravenous 30. Warning – Etoposide is TWO infusions Administration Instructions Due to the stability of etoposide the total dose of 200mg/m2 will be split into two infusions of 100mg/m2 in 1000ml sodium chloride 0.9% over 60 minutes. The two infusions are given sequentially, the second is started as soon as the first infusion is complete. The total duration of etoposide administration is 120minutes. 31. Etoposide 100mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% over 60 minutes Administration Instructions Due to the stability of etoposide the total dose of 200mg/m2 will be split into two infusions of 100mg/m2 in 1000ml sodium chloride 0.9% over 60 minutes. The two infusions are given sequentially, the second is started as soon as the first infusion is complete. The total duration of etoposide administration is 120minutes. 32. Etoposide 100mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% over 60 minutes Administration Instructions Due to the stability of etoposide the total dose of 200mg/m2 will be split into two infusions of 100mg/m2 in 1000ml sodium chloride 0.9% over 60 minutes. The two infusions are given sequentially, the second is started as soon as the first infusion is complete. The total duration of etoposide administration is 120minutes Day -1 33. Warning – Check CADD pump and sodium chloride pump removal 34. Aprepitant 125mg oral 35. Dexamethasone 2mg oral or intravenous 36. Ondansetron 8mg oral or intravenous 37. Metoclopramide 10mg oral or intravenous 38. Furosemide 20mg injection bolus Administration instructions – to be given if required for fluid overload. Version 1 (August 2023) Page 10 of 12 Lymphoma- AmB-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan 39. Warning – Check hydration and fluid balance Administration Instructions See separate fluid prescription for the pre hydration: The evening before melphalan infusion (to be completed by 0930 on the morning of the infusion) Sodium chloride 0.9% with potassium chloride 27mmol 1000ml The day of melphalan infusion: 0830hrs Contact Pharmacy on ext 5037 to inform them that the patient is present. Confirm that they have melphalan prescription (on ARIA) □ Request melphalan to be on the ward by 11:30 □ Start fluid balance sheet and start daily weight measurement 0915hrs Administer anti-emetics and supportive medication as per ARIA prescription 0930hrs 20mg furosemide intravenous bolus 1000hrs 1000ml sodium chloride 0.9% intravenous infusion over 90 minutes 1030hrs 20mg furosemide intravenous bolus Measure urine output since 0900hrs If more than 500ml continue with melphalan infusion If less than 500ml give second furosemide 20mg intravenous bolus dose and check urine output since 0900hrs again at 1100hrs: if more than 500ml go ahead with melphalan if less than 500ml contact the prescriber. 1130hrs – give melphalan intravenous infusion over thirty minutes (this product has a short expiry so adhering to set timing is essential) 1200hrs - 1000ml sodium chloride 0.9% intravenous infusion over 120 minutes 40. Time– Administer melphalan at 1130hrs 41. Melphalan 140mg/m2 intravenous infusion in 500ml sodium chloride 0.9% over 30 minutes Administration Instructions - see separate fluid prescription for the post hydration requirements Day 0 42. Chlorphenamine 10mg Intravenous bolus Administration instructions – to be given pre stem cell infusion 43. Paracetamol 1000mg Tablet Oral Administration instructions – to be given pre stem cell infusion 44. Stem Cell Return – see separate chart Version 1 (August 2023) Page 11 of 12 Lymphoma- AmB-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan DOCUMENT CONTROL Version Date Amendment Written By Approved By 1 August 2023 New document Madeleine Norbury Pharmacist Hwai Jing Hiew Consultant 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; University Hospital Southampton NHS Foundation Trust -Wessex Blood and Marrow Transplant 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 (August 2023) Page 12 of 12 Lymphoma- AmB-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan
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