IV Thiotepa/Busulfan/Fludarabine/ATGfor Unrelated Donor Allograft
INDICATIONS Acute myeloid leukaemia, acute lymphoblastic leukaemia, non-Hodgkin’s lymphoma: for unrelated donor allogeneic transplants PRE-ASSESSMENT
• 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
• Haematology SpR to complete electronic BMT front sheet and secretary to distribute and file in
• Prescribe chemotherapy and supportive treatment at least 5 days before admission • Send NHSBT Request form 2E (MUD) 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
• 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.
This is a controlled document and therefore must not be changed times Admission CHEMOTHERAPY 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 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 micron filter
Day –6 to – 4 Busulfan 3.2 mg/kg/iv/d in a single dose. 0.9% normal saline: Final
concentration 0.5mg/ml Give over 3 hours.
This is a controlled document and therefore must not be changed ATG TEST DOSE
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% 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 anti- platelet 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 -2 Methylprednisolone 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 Day -5 to -3 Fludarabine 50mg/m2/d iv in 100ml 0.9% sodium chloride over 30 minutes Day -5 to -2 Chlorphenamine 10mg iv bolus 30mins pre ATG Paracetamol 1g po 30mins pre ATG 2mg/kg iv od in 500ml sodium chloride 0.9% OVER 8 hours
Give hydrocortisone 100mg iv, chlorphenamine (formerly
chlorpheniramine) 10mg iv 15 minutes before cell infusion.
Pentamidine 300mg iv in 100ml sodium chloride 0.9% over 1 hour Methotrexate 15mg/m2 /iv bolus
(at least 24hr post bone marrow/stem cell infusion)
Day +3,+6, Methotrexate 10mg/m2/iv bolus
(Day 11 dose omitted for severe mucositis, check with
This is a controlled document and therefore must not be changed ADMINISTRATION OF CHEMOTHERAPY: Refer to nursing care plan N.86a, N86b BONE MARROW/STEM CELL INFUSION: Refer to nursing care plan N.51 or N.18 ANTI-EMETICS Day –8 to -3
CONCURRENT MEDICATION Clonazepam
2mg po nocte from day –7 to day – 3 inclusive
Norethisterone
5-10mg po tds from day 0 until platelets >50x109/l (menstruating women only)
Fluconazole
50mg od po from day 0 until neutrophils >1.0x109/l (or longer if on steroids ) (NOTE: INTERACTION WITH THIOTEPA THEREFORE DO NOT START UNTIL DAY 0) Aciclovir For CMV Prophylaxis If either donor or recipient or both are CMV + then: 500mg /m2 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 CMV 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
Ciclosporin
1.5mg/kg iv bd - total dose 3mg/kg/day (adjust for renal toxicity) in 20 -
100ml sodium chloride 0.9% over 2- 4hr from day –1. See protocol. Change to po prior to discharge. See Medication on Discharge
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 >50x109/l
This is a controlled document and therefore must not be changed MEDICATION ON DISCHARGE (TTOs) Norethisterone Fluconazole
Stop when neutrophils >1x 109/l (may be longer if patient on
Co-trimoxazole
960mg daily Mon, Wed, Fri: start when neutrophils >1.0 x 109/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.
Aciclovir
Depends on CMV/ HSV/ VZV status. Refer to page 3 of this protocol.
Omeprazole Ciclosporin
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.
Penicillin V
250mg bd to start on discharge and continue for life.
REFERENCE Sanz J, Boluda JC, Martín C, González M, Ferrá C, Serrano D, de Heredia CD, Barrenetxea C, Martinez AM, Solano C, Sanz MA, 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 Marrow Transplant. 2012 Feb 13 Audit These processes are subject to the OxBMT audit programme.
Author(s) Dr Andy Peniket and Prof. Vanderson Rocha Circulation Patient file, JACIE electronic document file Name Revision Version Review date
Dr Andy Peniket, Prof Vanderson New document
Thiotepa, Pen V for life from discharge.
This is a controlled document and therefore must not be changed
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IV Thiotepa/Busulfan/Fludarabine/ATG for Unrelated Donor Allograft 
times 
ATG TEST DOSE 
MEDICATION ON DISCHARGE (TTOs)