Maintenance Azacitidine in Elderly Patients With Acute Myeloid Leukemia (AML) in CR After Induction Chemotherapy

Inclusion Criteria

• Histologic or cytologic confirmation of AML with greater than 20% blasts in bone marrow. All AML subtypes of the World Health Organization (WHO) classification will be included with the exception of promyelocytic leukemia and cytogenetics showing the (15;17) translocation or AML secondary to chemotherapy.
• Achieved first morphologic complete remission (CR) or first morphologic complete remission with incomplete platelet recovery (CRp) after completion of induction chemotherapy using a standard induction regimen. Up to 2 induction cycles will be allowed. Confirmation of CR is defined as 1.0 x 10^9/L and platelet count >100 x 10^9/L. Confirmation of CRp is defined as 60 mL/min for patients with creatinine levels above ULN
• Men must agree to avoid fathering a child throughout the study.
• Be capable of giving informed consent and have signed the informed consent form (ICF)

Exclusion Criteria

• Greater than 12 weeks since initiation of most recent cycle of consolidation chemotherapy
• Women of childbearing potential
• Prior relapse after complete remission for AML
• AML secondary to previous exposure to cytotoxic chemotherapy known to induce leukemia
• Active malignancy other than AML
• Any diagnosis of metastatic disease
• Have hepatic tumors
• Radiation therapy, chemotherapy, or cytotoxic therapy, given to treat conditions other than AML 4 weeks earlier
• Known leukemic involvement of the central nervous system
• Known or suspected hypersensitivity to azacitidine or mannitol
• Prior or active disease that, in the opinion of the Investigator, may interfere with the procedures or evaluations to be conducted in the study (uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements)
• Active viral infection with known human immunodeficiency virus (HIV) or viral hepatitis type B or C
• Treatment with other investigational drugs within the 30 days prior to Day 1, or ongoing adverse events from previous treatment with investigational drugs, regardless of the time period
• Any prior treatment with azacitidine or decitabine