Leukemia Clinical Trial
Official title:
A Phase 2 Study of Imatinib Mesylate (Gleevec) as Maintenance Therapy After Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed C-kit Positive Acute Myeloid Leukemia
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 how well imatinib mesylate works in treating
patients with newly diagnosed acute myeloid leukemia who have received chemotherapy.
OBJECTIVES:
Primary
- To determine whether adding imatinib mesylate as maintenance therapy improves
progression-free survival in patients with c-kit positive acute myeloid leukemia (AML)
compared with historical controls.
Secondary
- To assess the feasibility of administering imatinib mesylate as maintenance therapy
after the completion of induction and consolidation therapy in these patients.
- To evaluate potential mechanisms of relapse/resistance in c-kit positive AML by
examining multidrug resistance gene expression and AF1q gene expression and to determine
whether these levels correlate with c-kit expression.
OUTLINE: This is a multicenter study.
Patients receive oral imatinib mesylate once daily for up to 12 months.
Bone marrow and peripheral blood are collected at baseline. Laboratory endpoints are
evaluated by flow cytometry; mutation and gene analysis by PCR.
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