Omacetaxine and Low Dose Cytarabine in Older Patients With Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
Condition: Leukemia
MeSH terms: Leukemia; Preleukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes
Intervention: Omacetaxine; Cytarabine
Intervention description: 1.25 mg/m2 subcutaneously (SQ) every 12 hours (+/- 3 hours) for 3 days (Days 1-3). Each cycle will be 4-7 weeks.; 20 mg subcutaneously every 12 hours (+/- 3 hours) for 7 days (Days 1-7). Each cycle will be 4-7 weeks.
Intervention MeSH terms: Cytarabine; Homoharringtonine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Acute Myelogenous Leukemia; AML; High-Risk Myelodysplastic Syndrome; MDS; Omacetaxine; Cytarabine; ARA-C; Cytosar; DepoCyt; Cytosine Arabinosine Hydrochloride

Summary:

      The goal of this clinical research study is to learn if omacetaxine given with cytarabine can
      help to control the disease in patients with AML or high-risk MDS. The safety of the study
      drugs will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Previously untreated AML (>/= 20% blasts). Patients with high-risk (intermediate-2 or
             high by International Prostate Symptom Score (IPSS) or ≥10% blasts) MDS will also be
             eligible. Prior therapy with hydroxyurea, biological or targeted therapy (e.g. flt3
             inhibitors, other kinase inhibitors, azacitidine), or hematopoietic growth factors is
             allowed. A single or a two day dose of cytarabine (up to 3 g/m2) for emergency use is
             also allowed as prior therapy.

          2. Age >/= 60 years.

          3. Eastern Cooperative Oncology Group (ECOG) performance status </= 2.

          4. Adequate hepatic (serum total bilirubin </= 1.5 x ULN, serum glutamate pyruvate
             transaminase (SGPT) and/or serum glutamate oxaloacetate transaminase (SGOT) </= 2.5 x
             ULN) and renal function (creatinine </= 2.0 mg/dL).

          5. Patients must be willing and able to review, understand, and provide written consent
             before starting therapy.

        Exclusion Criteria:

          1. New York Heart Association (NYHA) class III or IV heart disease, active ischemia or
             any other uncontrolled cardiac condition such as angina pectoris, clinically
             significant cardiac arrhythmia and requiring therapy, uncontrolled hypertension (blood
             pressure >/= 160 systolic and >/= 110 diastolic not responsive to antihypertensive
             medication), diabetes mellitus, or congestive heart failure.

          2. Myocardial infarction in the previous 12 weeks (from the start of treatment).

          3. Active and uncontrolled disease/infection as judged by the treating physician.

          4. Pregnancy.

          5. Acute promyelocytic leukemia (APL).

          6. Women of childbearing potential and men who do not practice contraception.
             Non-childbearing is defined as >/= 1 year postmenopausal or surgically sterilized.

          7. Women of childbearing potential and men must agree to use contraception prior to study
             entry and for the duration of study participation.