NCT00245128

Imatinib Mesylate in Treating Patients With Myelofibrosis

A Phase II Pilot Study to Determine the Safety and Preliminary Efficacy of Imatinib Mesylate (Gleevec) in Patients With Myelofibrosis With Myeloid Metaplasia

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Myeloproliferative Disorders

Interventions

Type	Name	Description
DRUG	imatinib mesylate	Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.

Timeline

• Start date: 2005-08-01
• Primary completion: 2007-03-01
• Completion: 2011-10-01
• First posted: 2005-10-27
• Last updated: 2012-01-13
• Results posted: 2012-01-13

Locations

1 site across 1 country: United States