Omacetaxine Mepesuccinate, Cytarabine, and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome; Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Leukemia, Monocytic, Acute; Leukemia, Myelomonocytic, Acute; Leukemia, Megakaryoblastic, Acute; Leukemia, Erythroblastic, Acute; Myelodysplastic Syndromes
Intervention: cytarabine; omacetaxine mepesuccinate; decitabine; laboratory biomarker analysis
Intervention description: Given SC; Given SC; Given IV; Correlative studies
Intervention MeSH terms: Cytarabine; Decitabine; Azacitidine; Homoharringtonine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      This phase II trial studies the side effects and how well omacetaxine mepesuccinate,
      cytarabine, and decitabine work in treating older patients with newly diagnosed acute myeloid
      leukemia. Omacetaxine mepesuccinate, cytarabine, and decitabine may stop the growth of cancer
      cells by blocking some of the enzymes needed for cell growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are not eligible for standard induction chemotherapy (or any standard
             therapy known to be life prolonging) because of poor performance status, significant
             tissue comorbidities, or unfavorable risk of disease

          -  Have an unequivocal histologic diagnosis of acute myeloid leukemia (AML) (including
             secondary AML)

          -  No prior therapy for AML except hydroxyurea to control counts

          -  Must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of
             birth control; abstinence) prior to study entry and for the duration of study
             participation

          -  Subject or legal representative must understand the investigational nature of this
             study and sign an independent ethics committee/institutional review board approved
             written informed consent form prior to receiving any study related procedure

        Exclusion Criteria:

          -  Subjects with the diagnosis of acute promyelocytic leukemia (t[15;17])

          -  Unwilling or unable to follow protocol requirements

          -  Any condition which in the investigator's opinion deems the subject an unsuitable
             candidate to receive study drug

          -  Patients with sickle cell disease and sickle cell crisis

          -  Received an investigational agent for another disease within 30 days prior to
             enrollment

          -  The patient has an uncontrolled and active infection that would preclude study conduct
             and assessment