S0501 Fludarabine, Melphalan, and Donor Stem Cell Transplant Followed By Tacrolimus and Methotrexate in Treating Patients for Relapsed Lymphoma
Summary
RATIONALE: Giving low doses of chemotherapy, such as fludarabine and melphalan, before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and methotrexate after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving fludarabine together with melphalan followed by tacrolimus and methotrexate works in treating patients who are undergoing a donor stem cell transplant for relapsed lymphoma.
Timeline
- Start
- 2005-07
- Primary completion
- 2008-01
- Completion
- 2011-12
Outcome
Outcome not reported
Stopped (Enrollment): “poor accrual”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Subject | Melphalan | Small molecule | 70 mg/m2 | Intravenous |
| Background | Methotrexate | Small molecule | 5 mg/m2 | Intravenous |
| Background | Tacrolimus | Small molecule | 0.03 mg/kg | Oral |