Imatinib Mesylate in Treating Patients With Myelofibrosis

Phase 2

Terminated

• Conditions: Chronic Myeloproliferative Disorders

• Registration Number: NCT00245128
• Lead Sponsor: OHSU Knight Cancer Institute

Brief Summary

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.

Detailed Description

OBJECTIVES:

Primary

* 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.

Secondary

* 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 Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-10-25
• Study First Submitted QC: 2005-10-25
• Study First Posted: 2005-10-27
• Primary Completion: 2007-03
• Study Completion: 2011-10
• Results First Submitted: 2011-10-25
• Status Verified: 2011-12
• Results First Submitted QC: 2011-12-01
• Last Update Submitted: 2011-12-01
• Results First Posted: 2012-01-13
• Last Update Posted: 2012-01-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Major and/or Minor Erythroid Responses at 3, 6, and 12 Months of Therapy	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.

Secondary Outcome Measures

Name	Time	Method
Reduction in Marrow Fibrosis and Decrease in Spleen Size	After 6 and 12 months of therapy

Trial Locations

Locations (1)

OHSU Knight Cancer Institute; 🇺🇸 Portland, Oregon, United States