Clinical Trial: Imatinib Mesylate After a Donor Stem Cell Transplant in Treating Patients With Philadelphia Chromosome-Positive Leukemia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multicenter Pilot Study Evaluating the Safety and Efficacy of Imatinib as Post-Transplant Therapy for High- Risk Philadelphia Chromosome-Positive Leukemias
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 Summary:
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.
Sponsor: Fred Hutchinson Cancer Research Center
Current Primary Outcome: Safety at 90 days following transplant
Original Primary Outcome:
Current Secondary Outcome:
- 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
Original Secondary Outcome:
Information By: Fred Hutchinson Cancer Research Center
Dates:
Date Received: October 25, 2005
Date Started: January 2004
Date Completion:
Last Updated: November 28, 2011
Last Verified: November 2011