Allogeneic Hematopoietic Cell Transplantation for Patients With Busulfex-based Regimen
Summary
RATIONALE: Giving chemotherapy, such as fludarabine and busulfan, before a donor peripheral stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving a monoclonal antibody, alemtuzumab, before the transplant and tacrolimus after the transplant may stop this from happening. PURPOSE: The phase I portion of this trial identified the maximum tolerated dose of busulfan after treating 40 patients on a dose-escalation scheme. We are now treating an additional 26 patients on the phase II portion of the trial at a Pharmacokinetic (PK)-directed dose of total area under curve (AUC) 6912 micrometer (uM)-min/24 hours. We transitioned to the Phase II portion of the study in October 2009.
Timeline
- Start
- 2005-10
- Primary completion
- 2015-11
- Completion
- 2015-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Busulfan | Small molecule | — | — |
| Subject | Thymoglobulin | Protein / enzyme biologic | 0.5 mg/kg | — |
| Subject | Thymoglobulin | Protein / enzyme biologic | 2.5 mg/kg | — |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Background | Methotrexate | Small molecule | 5 mg/m2 | — |
| Background | Tacrolimus | Small molecule | 0.03 mg/kg | Oral |
| Background | therapeutic allogeneic lymphocytes | Cell therapy | — | — |