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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Given orally
Correlative studies
University of Chicago
Chicago, Illinois, United States
Clinical responses in terms of improvement in anemia and splenomegaly as previously published for myelofibrosis
Time frame: Up to 12 months
Frequency of adverse events graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0
Exact 95% confidence intervals generated using the binomial distribution.
Time frame: Up to 12 months
Progression-free survival
Analyzed using the Kaplan-Meier method.
Time frame: Up to 12 months
Bone marrow response
Time frame: Up to 12 months
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