Imatinib Mesylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Who Have Received Chemotherapy

Inclusion Criteria

• •Diagnostic bone marrow aspirate/ biopsy or peripheral blood confirming AML.
• •At the time of diagnosis, patients must have c-kit (also known as CD117) positive AML (20% or more of the blasts express c-kit\[CD117\]).
• •A flow scattergram (from the diagnostic AML specimen) must be available to calculate a c-kit MFI.
• •Patients must have received standard induction chemotherapy with ADE (cytarabine, daunorubicin, and etoposide) or with 7+3 (7 days of cytarabine continuous infusion and 3 days of an anthracycline (idarubicin, daunorubicin, or mitoxantrone). Patients with persistent leukemia on a Day 10-28 marrow may have received a second course of chemotherapy.
• •After the completion of induction therapy, patients must have attained a complete remission based on blood count recovery (neutrophil count ≥ 1,000/µL, platelet count ≥ 100,000/µL), and bone marrow aspirate and biopsy (\< 5% myeloblasts).
• •For patients \< 60 years of age, patients must have received at least 2 courses of post-remission therapy with at least intermediate dose (400 mg/m2/day). \*Patients with t(8;21) or inversion 16 at the time of diagnosis must have received at least 2 courses of high dose cytarabine. For patients \> or = 60 years of age, patients must have received 1 course of post-remission therapy (the type of chemotherapy will not be specified).
• •Patients must be registered on this study (maintenance Imatinib mesylate) within 60 days of the last dose of post-remission therapy.
• •A bone marrow aspirate and/or biopsy must be done within 3 weeks of registration documenting CR.
• •Women of childbearing potential and sexually active males must use an effective method of contraception.
• •Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
• •ECOG Performance Status 0-2.
• •Creatinine must be ≤ 1.5 x upper limit of normal.
• •Total bilirubin must be ≤ 2 mg/dl and AST and ALT must be ≤ 2 times the upper limit of normal.
• •Previous treatment-related toxicities must have resolved to ≤ Grade 1 excluding alopecia.
• •Written, voluntary informed consent.