drugset / Trial / NCT00516152
Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing MUD SCT
NaSingle-groupOpen-labelTreatment
Summary
The primary objective of this study is to assess the safety and efficacy of performing unrelated stem cell transplants using intravenous busulfan and fludarabine as preparative therapy and tacrolimus plus methotrexate as the GVHD prophylaxis regimen. The goal is to demonstrate safety, aiming for a transplant related mortality rate (TRM) of \< or equal to 40% at 100 days. A TRM of \> or equal to 60% will be considered unacceptable. Another goal is to demonstrate efficacy by showing and overall survival of \>40% at 1-year following transplant.
Timeline
- Start
- 2002-11
- Primary completion
- —
- Completion
- 2007-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Busulfan | Small molecule | 0.8 mg/kg | Intravenous |
| Subject | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Subject | Methotrexate | Small molecule | 5 mg/m2 | Intravenous |
| Subject | Tacrolimus | Small molecule | 0.01 mg/kg | Intravenous |