drugset / Trial / NCT00469144
IV Busulfan With Allo-BMT: Study for Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome
RandomizedParallel-groupOpen-labelTreatment
Summary
The goal of this clinical research study is to learn if giving busulfan in a dose based on blood levels, along with a fixed (unchanging) dose of fludarabine, is more effective and causes fewer side effects for AML or myelodysplastic syndrome patients than the standard method of giving a fixed busulfan dose based on body size, along with a fixed dose of fludarabine. The safety of dosing based on blood levels will also be studied.
Timeline
- Start
- 2005-06
- Primary completion
- 2014-11
- Completion
- 2014-11
Outcome
Missed primary endpoint
registry analysis (unspecified test); Fixed Dose: Participants Not in CR vs Adjusted Dose: Participants Not in CR; p = 0.05; Wilcoxon (Mann-Whitney) NCT00469144 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Busulfan | Small molecule | 32 mg/m2 | Intravenous |
| Subject | Busulfan | Small molecule | 130 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 40 mg/m2 | Intravenous |