For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Wed, 10/01/2014 to Tue, 10/01/2019
Bone Marrow Disease(s):
myelodysplastic syndromes (MDS)
Drug: Busulfan Arm 1 - Busulfan 80 mg/m2 (PK Studies) on Day -13 and Day -12. Arm 2 - Busulfan 80 mg/m2 (PK Studies) on Day - 20 and Day -13. Both Arms - Busulfan administered after Cladribine at dose calculated to achieve a total (including first two doses) systemic exposure of 20,000 ± 12% µMol-min based on pharmacokinetic studies on Days -6 to -3. Other Names: Busulfex Myleran Drug: Fludarabine Arm 1 and 2 - Fludarabine 10 mg/m2 on Days -6 through -3. Other Names: Fludarabine Phosphate Fludara Drug: Cladribine Both Arms - Cladribine 10 mg/m2 administered after Fludarabine on Days -6 through -3. Other Names: Leustatin 2-CdA Procedure: Stem Cell Transplant Both Arms - Stem cell transplant on Day 0. Drug: G-CSF Both Arms - G-CSF 5 mcg/kg/day subcutaneously on Day +7, and continuing until absolute neutrophil count (ANC) is > 500 x 109/L for 3 consecutive days. Other Names: Filgrastim Neupogen Drug: Methotrexate Both Arms - Methotrexate 5 mg/m2 on Days +1, +3, +6, and +11 post bone marrow transplant.