drugset / Trial / NCT00499889
Imatinib Mesylate, Busulfan, Fludarabine, and Antithymocyte Globulin for CML Patients
NaSingle-groupOpen-labelTreatment
Summary
Primary Objective: To estimate the probability of molecular complete remission at one year for the described sequential treatment approach, with nonablative hematopoietic transplantation, post transplant imatinib mesylate and donor lymphocyte infusion, in patients with Ph-positive Chronic Myelogenous Leukemia (CML) not in blastic transformation. Secondary Objective: Response to post transplant Imatinib mesylate therapy for 12 weeks as treatment of residual disease, response to donor lymphocyte infusion (DLI) for residual disease following imatinib mesylate therapy, as well as engraftment, toxicity, disease free survival and survival, effect of busulfan pharmacokinetics on study outcome.
Timeline
- Start
- 2003-02
- Primary completion
- 2009-11
- Completion
- 2009-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Busulfan | Small molecule | 130 mg/m2 | Intravenous |
| Subject | Imatinib | Small molecule | 400 mg | Oral |
| Background | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | 2.5 mg/kg | Intravenous |
| Background | Fludarabine | Small molecule | 40 mg/m2 | Intravenous |
| Background | Methotrexate | Small molecule | 5 mg/m2 | — |
| Background | Tacrolimus | Small molecule | — | Intravenous |