Busulfan and Cyclophosphamide Followed By ALLO BMT | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT01685411

Busulfan and Cyclophosphamide Followed By ALLO BMT
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

This is a treatment guideline to allow routine clinical data to be collected and maintained in Oncore (clinical database) and the University of Minnesota Blood and Marrow Database as part of the historical database maintained by the department.

Status: 
Recruiting
Study Date: 
Tue, 01/01/2013 to Mon, 09/01/2025
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Intervention: 
Drug: Allopurinol Day -8 (prior to transplant): Per institutional guidelines Other Names: Lopurin Zyloprim Drug: Keppra Day -8 (prior to transplant): Per institutional guidelines Other Name: Levetiracetam Drug: Busulfan Days -7 through -4 (prior to transplant): given intravenously (IV) infusion over 2 hours every 6 hours following dose, administration and pharmacokinetic monitoring per University of Minnesota institutional guidelines. Other Name: Myleran Drug: Cyclophosphamide Days -3 and -2 (prior to transplantation): given as a 2 hour intravenous infusion with a high volume fluid flush and mesna per institutional guidelines. Dosing is based on actual body weight. Other Name: Cytoxan Drug: Cyclosporine A Day -3 (prior to transplant) and will be administered by mouth/intravenously (PO/IV) maintaining a trough level between 200 and 400 ng/mL. Adult initial dose will be 2.5 mg/kg IV over 2 hours every 12 hours. Children < 40 kg will be 2.5 mg/kg IV over 2 hours every 8 hours. Other Name: CSA Drug: Mycophenolate mofetil Day -3 (prior to transplant): Recipients of umbilical cord blood will given a dose of 3 gm/day every 8 or 12 hours (> or = 40 kg) or 15 mg/kg 3 times per day (< 40 kg) for up to 30 days unless no engraftment. Other Name: MMF Biological: Allogeneic hematopoietic stem cell transplant Day 0 (or Day+1/+2 to accommodate weekdays): Infusion of cells from related or unrelated donor bone marrow or single or double unrelated donor umbilical cord blood. Biological: Filgrastim Beginning Day +1: Intravenously (IV) 5 mcg/kg once daily and continuing until the absolute neutrophil count is >2500 x 10^9/L or per institutional guidelines. Other Names: G-CSF Granulocyte-colony stimulating factor Biological: antithymocyte globulin Administered per institutional guidelines for recipients of umbilical cord blood transplant. Other Name: ATG