A Multicenter, Phase 2 Study of Maintenance Azacitidine in Elderly Patients With Acute Myeloid Leukemia in Complete Remission 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 < 5% blasts in the bone marrow specimen,
with a count of at least 100-200 nucleated cells and absence of Auer rods, along with
peripheral blood neutrophil count >1.0 x 10^9/L and platelet count >100 x 10^9/L.
Confirmation of CRp is defined as <5% blasts in the bone marrow specimen, with a
count of at least 100-200 nucleated cells and absence of Auer rods, with incomplete
platelet recovery (ANC ≥ 1000/µL and platelets 50-99,000/µL, along with
transfusion-independence of red blood cells).

- Received up to 2 cycles of any consolidation chemotherapy

- Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤2

- Normal organ function at the time of screening: Total bilirubin ≤1.5 x upper limit of
normal (ULN); aspartic transaminase (AST) and alanine transaminase (ALT) ≤2.5 x ULN;
Serum creatinine ≤1.5 x ULN or creatinine clearance >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 prior to Day 1 or have not recovered from adverse events due
to agents administered >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