Leukemia Clinical Trial
Official title:
A Multicenter Pilot Study Evaluating the Safety and Efficacy of Imatinib as Post-Transplant Therapy for High- Risk Philadelphia Chromosome-Positive Leukemias
RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the
enzymes needed for cell growth. Giving imatinib mesylate after a donor stem cell transplant
may prevent the recurrence of Philadelphia chromosome-positive leukemia.
PURPOSE: This phase I/II trial is studying the side effects of giving imatinib mesylate
after a donor stem cell transplant and to see how well it works in treating patients with
Philadelphia chromosome-positive leukemia.
OBJECTIVES:
Primary
- Determine the safety of adjuvant imatinib mesylate after allogeneic hematopoietic stem
cell transplantation (AHSCT) in patients with high-risk Philadelphia
chromosome-positive leukemia.
Secondary
- Determine the bcr/abl transcript load during the first 90 days after AHSCT in patients
treated with this drug from the time of engraftment.
- Determine the 1-year survival of patients treated with this drug.
OUTLINE: This is an open-label, pilot, multicenter study.
Beginning within 14-30 days after allogeneic stem cell transplantation, patients receive
oral imatinib mesylate once daily until 1 year after transplantation. Treatment continues in
the absence of unacceptable toxicity or disease progression.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
;
Masking: Open Label, Primary Purpose: Treatment
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