Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
University of California, San Francisco
With
OBJECTIVES: Primary * 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. Secondary * 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 this regimen. OUTLINE: * 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.
Age
16–60
Sex
ALL
Healthy volunteers
Not accepted
