Liposomal Cytarabine-Daunorubicin CPX-351 in Treating Patients With Untreated Myelodysplastic Syndrome or Acute Myeloid Leukemia

Inclusion Criteria:

   - Diagnosis of untreated "high-risk" MDS (>= 10% blasts) or AML other than acute
   promyelocytic leukemia (APL) with t(15;17)(q22;q12) or variants according to the 2008
   World Health Organization (WHO) classification; patients with biphenotypic AML are
   eligible; outside diagnostic material is acceptable as long as peripheral blood and/or
   bone marrow slides are reviewed at the study institution and cytogenetic/molecular
   information is available

      - Prior hydroxyurea for AML is permitted but should be discontinued prior to start
      of CPX-351 treatment

      - Azacitidine, decitabine, lenalidomide, and growth factors are permitted for
      low-risk MDS (< 10% blasts); all treatments for MDS should be discontinued prior
      to start of CPX-351 treatment

   - Treatment-related mortality (TRM) score >= 13.1 as calculated with simplified model

   - Bilirubin < 2.0 mg/mL x upper limit of normal; this requirement reflects the excretion
   of CPX-351 by the liver

   - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 4.0 x upper limit of
   normal; this requirement reflects the excretion of CPX-351 by the liver

   - Left ventricular ejection fraction (LVEF) >= 40%, assessed within 28 days prior to
   registration, e.g. by multi gated acquisition (MUGA) scan or echocardiography, or
   other appropriate diagnostic modality

   - Patients with symptoms/signs of hyperleukocytosis or white blood cell (WBC) >
   100,000/uL can be treated with leukapheresis prior to enrollment

   - Provide signed written informed consent

Exclusion Criteria:

   - Refractory/relapsing blast crisis of chronic myelogenous leukemia (CML)

   - Concomitant illness associated with a likely survival of < 1 year

   - Active systemic fungal, bacterial, viral, or other infection, unless under treatment
   with anti-microbials and controlled/stable, as defined as being afebrile and
   hemodynamically stable for 24-48 hours