drugset / Trial / NCT00469014
Busulfan, Fludarabine, Clofarabine With Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia
RandomizedParallel-groupOpen-labelTreatment
Summary
The goal of this clinical research study is to find the best dose of clofarabine and fludarabine that can be given with busulfan followed by an allogeneic blood stem cell transplant. Researchers will study whether this combination can help to control the disease, and look at the safety of this combination. Researchers also want to find out if combining busulfan with clofarabine alone or combining busulfan with both fludarabine and clofarabine will improve the treatment, compared with the previous standard method using busulfan and fludarabine alone.
Timeline
- Start
- 2006-09
- Primary completion
- 2013-03
- Completion
- 2013-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Busulfan | Small molecule | 10 mg/m2 | Intravenous |
| Subject | Busulfan | Small molecule | 20 mg/m2 | Intravenous |
| Subject | Busulfan | Small molecule | 30 mg/m2 | Intravenous |
| Subject | Busulfan | Small molecule | 40 mg/m2 | Intravenous |
| Subject | Clofarabine | Other / unclassified | 10 mg/m2 | Intravenous |
| Subject | Clofarabine | Other / unclassified | 20 mg/m2 | Intravenous |
| Subject | Clofarabine | Other / unclassified | 30 mg/m2 | Intravenous |
| Subject | Clofarabine | Other / unclassified | 40 mg/m2 | Intravenous |
| Subject | Fludarabine | Small molecule | 10 mg/m2 | Intravenous |
| Subject | Fludarabine | Small molecule | 20 mg/m2 | Intravenous |
| Subject | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Background | Thymoglobulin | Protein / enzyme biologic | 2 mg/kg | Intravenous |
| Background | filgrastim | Protein / enzyme biologic | — | Subcutaneous |