Busulfan and Fludarabine Before Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer
RATIONALE: Drugs used in chemotherapy, such as busulfan and fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy with a peripheral stem cell or bone marrow transplant may allow more chemotherapy to be given so that more cancer cells are killed. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Tacrolimus and methotrexate may stop this from happening.
PURPOSE: This phase II trial is studying how well giving busulfan together with fludarabine before donor stem cell transplant works in treating patients with hematologic cancer.
|Anemia Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases||Biological: filgrastim Drug: busulfan Drug: fludarabine phosphate Drug: methotrexate Drug: tacrolimus Procedure: allogeneic bone marrow transplantation Procedure: allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation||Phase 2|
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing Matched Unrelated Donor Stem Cell Transplantation|
- Treatment-related mortality in the first 100 days post-transplant
- Overall survival at 1 year post-transplant
- Incidence and severity of organ-specific toxicity
- Engraftment including neutrophil and platelet recovery and donor chimerism at 3 and 12 months post-transplant
- Rate of acute graft-vs-host disease (GVHD)
- Rate of chronic GVHD
|Study Start Date:||January 2002|
|Primary Completion Date:||November 2007 (Final data collection date for primary outcome measure)|
- 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 this regimen.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00301912
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|Study Chair:||Thomas G. Martin, MD||University of California, San Francisco|