NCT00039416

Imatinib Mesylate in Treating Patients With Myelofibrosis

A Phase II Study Of Gleevec (Imatinib Mesylate Formerly Known as STI-571) In Patients With Myelofibrosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have myelofibrosis. Imatinib mesylate may stop the growth of myelofibrosis by blocking certain enzymes necessary for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To determine the response rate (complete and partial) to STI-571 in patients with myelofibrosis. II. To determine the safety of STI-571 in patients with myelofibrosis. SECONDARY OBJECTIVES: I. To determine the effects of STI-571 on bone marrow morphology (including effects on marrow fibrosis, osteosclerosis and cellularity) in patients with myelofibrosis. II. To assess the effects of STI-571 on surrogate biologic endpoints including PDGFR expression (by immunohistochemistry), PDGFR signaling, and circulating progenitor (CD34 positive) cells. III. To determine the effects of STI-571 on bone marrow cytogenetics in patients with an abnormal karyotype. OUTLINE: This is a multicenter study. Patients are stratified according to Dupriez risk score (low vs intermediate vs high). Patients receive oral imatinib mesylate once or twice daily on days 1-28. Courses repeat every 28 days for 12 months in the absence of disease progression or unacceptable toxicity.

Conditions

• Chronic Myelomonocytic Leukemia
• Essential Thrombocythemia
• Polycythemia Vera
• Primary Myelofibrosis

Interventions

Type	Name	Description
DRUG	imatinib mesylate	Given orally
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2002-04-01
• Primary completion: 2007-08-01
• First posted: 2003-01-27
• Last updated: 2014-02-25

Locations

1 site across 1 country: United States