drugset / Trial / NCT01003054
Autologous Transplantation for Chronic Myelogenous Leukemia
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The goal of this clinical research is to learn if treatment with high-dose busulfan and cyclophosphamide plus autologous bone marrow transplantation followed by treatment with Gleevec (imatinib mesylate) is effective in treating chronic myelogenous leukemia (CML). Objectives: 1. To assess the efficacy of high dose busulfan-cyclophosphamide and autologous hematopoietic transplantation with post transplant Imatinib mesylate for the treatment of CML. The primary endpoint of the study is to determine the proportion of patients with CML alive in cytogenetic remission at one year following this treatment. 2. Secondary endpoints are time to progression and survival.
Timeline
- Start
- 2005-03
- Primary completion
- 2007-12
- Completion
- 2009-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Busulfan | Small molecule | 130 mg/m2 | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 60 mg/kg | Intravenous |
| Subject | Imatinib | Small molecule | 400 mg | Oral |