Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing Matched Unrelated Donor Stem Cell Transplantation
- Determine the safety, in terms of treatment-related mortality at 100 days
post-transplantation, of a myeloablative preparative regimen comprising busulfan and
fludarabine and graft-vs-host disease (GVHD) prophylaxis comprising tacrolimus and
methotrexate in patients with hematopoietic disorders undergoing matched unrelated
donor stem cell transplantation.
- Determine the efficacy, in terms of overall survival at 1-year post-transplantation, in
patients treated with this regimen.
- Determine organ toxicity in patients treated with this regimen.
- Determine neutrophil and platelet recovery in patients treated with this regimen.
- Determine the incidence and severity of acute and chronic GVHD in patients treated with
- Myeloablative preparative regimen: Patients receive busulfan IV over 2 hours every 6
hours on days -7 to -4 and fludarabine IV over 30 minutes on days -7 to -3.
- Allogeneic stem cell transplantation: Patients undergo allogeneic peripheral blood stem
cell or bone marrow transplantation on day 0. Patients also receive filgrastim (G-CSF)
subcutaneously daily beginning on day 7 and continuing until blood counts recover.
- Graft-vs-host disease prophylaxis: Patients receive tacrolimus IV continuously
beginning on day -2 and continuing until discharged from the hospital (may convert to
oral dosing administered twice daily when tolerated) and methotrexate IV over 15-30
minutes on days 1, 3, 6, and 11.
After completion of study therapy, patients are followed periodically.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Treatment-related mortality in the first 100 days post-transplant
Thomas G. Martin, MD
University of California, San Francisco
United States: Federal Government
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|