IV Thiotepa/Busulfan/Fludarabine/ATG for Allograft

Transcription

1 Oxford BT Programme IV Thiotepa/Busulfan/Fludarabine/ATG for Allograft INDICATIONS Acute myeloid leukaemia, acute lymphoblastic leukaemia, non-hodgkin s lymphoma: for related and unrelated donor allogeneic transplants PRE-ASSESSENT Ensure pre-transplant investigations are carried out as per protocol B3.10b Ensure patient has triple or double lumen Hickman line insitu. Ensure results of pre-transplant investigations are checked by a Haematology SpR and recorded in patient record Haematology SpR to complete electronic BT front sheet and secretary to distribute and file in patient record Prescribe chemotherapy and supportive treatment at least 5 days before admission Send NHSBT Request form 2E (UD) to NHSBT at least 7 working days before the planned collection date and ensure a copy is placed in the medical notes. Ensure donor clearance is obtained, reviewed and documented in recipient s notes prior to admission Ensure that the blood bank is notified that the patient is to receive irradiated blood products from the start of conditioning (see protocol on irradiated blood products) Day -9: Ensure a pregnancy test is carried out on all women of child-bearing potential unless they have been sterilized or have undergone a hysterectomy, document results in medical notes. B2.4 Page 1 of 5 Feb 2014 IVThioBuFluATG, Sib Allo/UD

2 Oxford BT Programme SUARY DRUG/ times Admission Thiotepa Clonazepam nocte Busulfan Fludarabine Rabbit ATG (rbatg) test dose ethylprednisolone rbatg Pentamidine arrow/stem cell infusion Ciclosporin Heparin Guide to first-line antiemetics: = 3 antagonist =etoclopramide ethotrexate Day +1,+3,+6, (+11) CHEOTHERAPY AND FLUIDS Encourage 3L oral fluids daily, give IV if oral intake insufficient. Nurses: Ensure flush volumes are included in rate and volume calculations, i.e. drug and flush should be completed within prescribed administration time. Day -9 to +30 Heparin Continuous infusion 200 units / kg over 48 hours (VOD prophylaxis) Day -8 to -7 Thiotepa 5 mg/kg/iv/d over 4 hours in 500ml normal saline, via a 0.22 Day 6 to Day -6 Busulfan ATG TEST DOSE micron filter 3.2 mg/kg/iv/d in a single dose. 0.9% normal saline: Final concentration 0.5mg/ml Give over 3 hours. 2.5 mg/one time only/iv in 100ml sodium chloride 0.9% over 1 hour through a 0.22 micron filter. Flush with sodium chloride 0.9% B2.4 Page 2 of 5 Feb 2014 IVThioBuFluATG, Sib Allo/UD

3 Oxford BT Programme Test dose must be supervised by a doctor with adrenaline, chlorphenamine, hydrocortisone drawn up beforehand. Each ATG dose must be completed within 18 hours of being made up. Platelet count must be maintained > 30 but platelet transfusion should not be given concurrently with ATG because of its antiplatelet activity. If possible avoid giving more than 1 unit of red cells each day of ATG to help avoid the risk of fluid overload. Day -5 to /18.00 Day -5 to -3 Day -5 to ethylprednisolone Fludarabine Chlorphenamine Paracetamol ATG 1mg/kg iv bd (NOTE Day -6: only evening dose to be given: Day -2 only morning dose to be given) in 100ml sodium chloride 0.9% over 15 minutes 50mg/m 2 /d iv in 100ml 0.9% sodium chloride over 30 minutes 10mg iv bolus 30mins pre ATG 1g po 30mins pre ATG 2mg/kg iv od in 500ml sodium chloride 0.9% OVER 8 hours through a 0.22 micron filter Day ml sodium chloride 0.9% over 6hrs Stem cell/marrow Give hydrocortisone 100mg iv, chlorphenamine (formerly infusion chlorpheniramine) 10mg iv 15 minutes before cell infusion. Day +1 Pentamidine 300mg iv in 100ml sodium chloride 0.9% over 1 hour Day +1 ethotrexate 15mg/m 2 /iv bolus (at least 24hr post bone marrow/stem cell infusion) Day +3,+6, (+11) ethotrexate 10mg/m 2 /iv bolus (Day 11 dose omitted for severe mucositis, check with At the same consultant). time as Day 1 B2.4 Page 3 of 5 Feb 2014 IVThioBuFluATG, Sib Allo/UD

4 Oxford BT Programme ADINISTRATION OF CHEOTHERAPY: Refer to nursing care plan N.86a, N86b BONE ARROW/STE CELL INFUSION: Refer to nursing care plan N.51 or N.18 ANTI-EETICS Day 8 to -3 etoclopramide 20mg po/iv/qds 3 antagonist po/iv/od CONCURRENT EDICATION Clonazepam 2mg po nocte from day 7 to day 3 inclusive Norethisterone 5-10mg po tds from day 0 until platelets >50x10 9 /l (menstruating women only) Fluconazole 50mg od po from day 0 until neutrophils >1.0x10 9 /l (or longer if on steroids ) (NOTE: INTERACTION WITH THIOTEPA THEREFORE DO NOT START UNTIL DAY 0) Aciclovir For CV Prophylaxis If either donor or recipient or both are CV + then: 500mg /m 2 tds iv or 800mg po qds day -7 to day +30 then 800mg po qds for 3 months, then 200mg tds for further 3 months if VZV positive If both donor and recipient are CV negative then consider HSV/VZV Prophylaxis Aciclovir dose is 250mg iv tds or 200mg po tds Duration of treatment depends on HSV and VZV status of recipient: HSV neg and VZV neg no aciclovir needed HSV pos and VZV neg treat for 3 months HSV pos and VZV pos treat for 6 months HSV neg and VZV pos treat for 6 months Ciclosporin 1.5mg/kg iv bd - total dose 3mg/kg/day (adjust for renal toxicity) in ml sodium chloride 0.9% over 2-4hr from day 1. See protocol. Change to po prior to discharge. See edication on Discharge Heparin 200iu/kg/48hr infusion in 48 ml sodium chloride 0.9% infused at 1ml/hr from admission to day +30 or discharge Allopurinol 300mg od for 7 days only in patients with acute leukaemia who are not in remission. Omeprazole 20mg od from start of conditioning until platelet count >50x10 9 /l B2.4 Page 4 of 5 Feb 2014 IVThioBuFluATG, Sib Allo/UD

5 EDICATION ON DISCHARGE (TTOs) Department of Clinical Haematology Oxford BT Programme Norethisterone Stop when platelets >50 x 10 9 /l Fluconazole Co-trimoxazole Aciclovir Omeprazole Ciclosporin Penicillin V Stop when neutrophils >1x 10 9 /l (may be longer if patient on steroids) 960mg daily on, Wed, Fri: start when neutrophils >1.0 x 10 9 /l and continue until one month after immunosuppressive therapy stopped. If allergic to co-trimoxazole, pentamidine 4mg/kg iv monthly. When co-trimoxazole is stopped, start Penicillin V 250mg bd. Depends on CV/ HSV/ VZV status. Refer to page 3 of this protocol. Stop unless clinically indicated On discharge the patient should be prescribed an oral dose of two times the last intravenous dose. See protocol. Check with registrar or consultant. Consider tailing from day +120 in the absence of GvHD. 250mg bd to start on discharge and continue for life. REFERENCE Sanz J, Boluda JC, artín C, González, Ferrá C, Serrano D, de Heredia CD, Barrenetxea C, artinez A, Solano C, Sanz A, Sanz GF.Single-unit umbilical cord blood transplantation from unrelated donors in patients with hematological malignancy using busulfan, thiotepa, fludarabine and ATG as myeloablative conditioning regimen. Bone arrow Transplant Feb 13 Audit These processes are subject to the OxBT audit programme. Author(s) Dr Andy Peniket and Prof. Vanderson Rocha Circulation Patient file, JACIE electronic document file Name Revision Date Version Review date Dr Andy Peniket, Prof New document Sept Sept 2014 Vanderson Rocha Lara Rowley, BT NP Filtration of Thiotepa, Pen arch arch 2015 V for life from discharge. Sandy Hayes, Quality manager Name change to incorporate Sib Allograft use February arch 2015 B2.4 Page 5 of 5 Feb 2014 IVThioBuFluATG, Sib Allo/UD