Phase II Study of Decitabine and Cytarabine for Older Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

Exclusion Criteria

• •1. Patients with acute promyelocytic leukemia
• •2. Life expectancy ≤3 months
• •3. Prior use of any hypomethylating agent or cytarabine
• •4. Uncontrolled, life-threatening infection that is not responding to antimicrobial therapy
• •5. Serum creatinine \> 2x upper limit of normal
• •6. Aspartate aminotransferase (AST),alanine aminotransferase (ALT), or total bilirubin \> 5x upper limit of normal
• •7. History of psychiatric disorder which may compromise compliance with the protocol or which does not allow for appropriate informed consent
• •8. Patient may not be receiving any other antineoplastic agents (hydroxyurea is allowed)
• •9. Concurrent malignancy. Exception: Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. Subjects with second malignancies that are indolent or definitively treated may be enrolled.
• •10. Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal, or cardiac disease).