The primary objective of this study is to assess the safety and efficacy of performing unrelated stem cell transplants using intravenous busulfan and fludarabine as preparative therapy and tacrolimus plus methotrexate as the GVHD prophylaxis regimen. The goal is to demonstrate safety, aiming for a transplant related mortality rate (TRM) of \< or equal to 40% at 100 days. A TRM of \> or equal to 60% will be considered unacceptable. Another goal is to demonstrate efficacy by showing and overall survival of \>40% at 1-year following transplant.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Day Preparative Regimen for GVHD Prophylaxis * 7 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV * 6 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV * 5 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV * 4 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV * 3 Fludarabine 30 mg/m(2)IV * 2 REST Tacrolimus 0.01 mg/kg CIVI * 1 REST 0 Unrelated Stem Cell/Bone Marrow Infusion * 1 Methotrexate 5mg/m(2)IV * 3 Methotrexate 5mg/m(2)IV * 6 Methotrexate 5mg/m(2)IV * 7 G-CSF 5mcg/kg SQ daily * 11 Methotrexate 5mg/m(2)IV * 90 Evaluate Response
University of California San Francisco
San Francisco, California, United States
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