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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Safety at 90 days following transplant
BCR/ABL transcript load at 90 days following transplant
Standard management of progressive minimal residual disease at 90 days following transplant
Survival at 1 year
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