Conditions: Chronic Myeloproliferative Disorders
Keywords: chronic idiopathic myelofibrosis polycythemia vera essential thrombocythemia
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 10
Healthy volunteers: no

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.

Arms:

Interventions: intervention 1: imatinib mesylate
Intervention descriptions: intervention 1: Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.

Protocol document: