Chronic Myeloproliferative Disorders Clinical Trial
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
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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