Imatinib Mesylate, Busulfan, Fludarabine, and Antithymocyte Globulin for CML Patients
Status:
Terminated
Trial end date:
2009-11-01
Target enrollment:
Participant gender:
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.