Imatinib Mesylate After a Donor Stem Cell Transplant in Treating Patients With Philadelphia Chromosome-Positive Leukemia
- Conditions
- Leukemia
- Registration Number
- NCT00244829
- Lead Sponsor
- Fred Hutchinson Cancer Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety at 90 days following transplant
- Secondary Outcome Measures
Name Time Method Survival at 1 year BCR/ABL transcript load at 90 days following transplant Standard management of progressive minimal residual disease at 90 days following transplant
Trial Locations
- Locations (2)
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
City of Hope Comprehensive Cancer Center🇺🇸Duarte, California, United States