Imatinib Mesylate in Treating Patients With Myelofibrosis
RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying the side effects of imatinib mesylate and how well it works in treating patients with myelofibrosis.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Pilot Study to Determine the Safety and Preliminary Efficacy of Imatinib Mesylate (Gleevec) in Patients With Myelofibrosis With Myeloid Metaplasia|
- Percentage of Participants With Major and/or Minor Erythroid Responses at 3, 6, and 12 Months of Therapy [ Time Frame: At 3,6, and 12 months of therapy ] [ Designated as safety issue: No ]
A major response = transfusion independent or a>2.0g/dl rise in hemoglobin without transfusion maintained for at least 8 weeks.
Minor response= > 1 to 2.0g/dl incremental rise in hemoglobin maintained for at lease 8 weeks with a decrease in transfusion requirements of at least 50% compared to the mean transfusion requirement during the 8 week pre-study period.
- Reduction in Marrow Fibrosis and Decrease in Spleen Size [ Time Frame: After 6 and 12 months of therapy ] [ Designated as safety issue: No ]
|Study Start Date:||August 2005|
|Study Completion Date:||October 2011|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
Drug: imatinib mesylate
- Determine the safety, efficacy, and tolerability of imatinib mesylate in patients with myelofibrosis with myeloid metaplasia.
- Determine the 3-, 6-, and 12-month major and minor erythroid response rates in patients treated with this drug.
- Determine reduction in marrow fibrosis in patients treated with this drug.
- Determine decrease in spleen size in patients treated with this drug.
OUTLINE: This is a multicenter, open-label, nonrandomized, pilot study.
Patients receive oral imatinib mesylate once daily for 1 year in the absence of disease progression or unacceptable toxicity. Patients who do not experience a minor erythroid response or a 50% reduction in spleen size after 6 months of treatment are removed from the study. Patients experiencing clinical benefit (e.g., ongoing erythroid response) after 1 year of treatment may continue treatment with imatinib mesylate as above at the discretion of the principal investigator.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
|United States, Oregon|
|OHSU Knight Cancer Institute|
|Portland, Oregon, United States, 97239-3098|
|Principal Investigator:||Michael Mauro, MD||OHSU Knight Cancer Institute|