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Adults = 60 years of age must have been newly diagnosed with acute myeloid leukemia (AML). AST, ALT and total bilirubin must be = Grade 1. ECOG performance status must be 0 - 3. They must not have blastic transformation of chronic myelogenous leukemia, an active, uncontrolled infection, AML-M3 (APL) or t(15;17)(q22;q21). They must not have received prior chemotherapy for AML with the exception of hydroxyurea for increased blast count or leukapheresis for leukocytosis. Patients who have received previous treatment with 5-azacitidine, decitabine or low-dose cytarabine will be excluded. Patients must have a cardiac ejection fraction of = 45 percent or within institutional normal limits. Total serum bilirubin must be = 1.5 x ULN and a serum creatinine = 1 mg/dL. Patients with known HIV infection are excluded.
The purpose of the study is to compare the effect of clofarabine versus standard therapy in newly diagnosed acute myeloid leukemia (AML) patients who are 60 years of age or older.