Maintenance Azacitidine in Elderly Patients With Acute Myeloid Leukemia (AML) in CR After Induction Chemotherapy
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid, Acute
Intervention: Azacitidine
Intervention description: Azacitidine given subcutaneously as outlined in treatment arm.
Intervention MeSH terms: Azacitidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: myeloid; acute; monocytic

Summary:

      The purpose of this study is to find out if patients older than 60, with acute myeloid
      leukemia, who are in complete remission following initial chemotherapy, will live longer and
      have a lower rate of leukemia relapse when treated with azacitidine.
    

Eligibility criteria:

        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