Imatinib Mesylate in Treating Patients With Myelofibrosis
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|ClinicalTrials.gov Identifier: NCT00245128|
Recruitment Status : Terminated (Per PI, results from another similar study were published prior to study analysis. Negative study results were published therefore analysis was not completed)
First Posted : October 27, 2005
Results First Posted : January 13, 2012
Last Update Posted : January 13, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myeloproliferative Disorders||Drug: imatinib mesylate||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2005|
|Actual Primary Completion Date :||March 2007|
|Actual Study Completion Date :||October 2011|
- Drug: imatinib mesylate
Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.
- 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 ]
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00245128
|United States, Oregon|
|OHSU Knight Cancer Institute|
|Portland, Oregon, United States, 97239-3098|
|Principal Investigator:||Michael Mauro, MD||OHSU Knight Cancer Institute|