Vosaroxin and Infusional Cytarabine in Treating Patients With Untreated Acute Myeloid Leukemia

Inclusion Criteria

• Ability to provide informed consent
• Ability to tolerate intensive therapy with vosaroxin 90 mg/m^2 and cytarabine
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2 at time of study entry
• Morphologically confirmed new diagnosis of AML in accordance with World Health Organization (WHO) diagnostic criteria
• Patients who have received hydroxyurea alone or have previously received "non-cytotoxic" therapies for myelodysplastic syndromes (MDS) or myeloproliferative neoplasms (MPN) (e.g., thalidomide or lenalidomide, 5-azacytidine or decitabine, histone deacetylase inhibitors, low-dose Cytoxan, tyrosine kinase or dual tyrosine kinase [TK]/SRC proto-oncogene, non-receptor tyrosine kinase [src] inhibitors) will be allowed
• Serum creatinine = = 55 years of age with AML of any risk classification, or 18-54 years of age with high-risk AML disease based on one of the following:
• Antecedent hematologic disorder including myelodysplasia (MDS)-related AML (MDS/AML) and prior myeloproliferative disorder (MPD)
• Treatment-related myeloid neoplasms (t-AML/t-MDS)
• AML with FMS-like tyrosine kinase 3 (FLT3) - internal tandem duplication (ITD)
• Myeloid sarcoma
• AML with multilineage dysplasia (AML-MLD)
• Adverse cytogenetics (defined as -5/-5q; -7/-7q; abnormal 3q, 9q, 11q, 20q, 21q or 17p; t(6;9); t(9;22); trisomy 8; trisomy 13; trisomy 21; complex karyotypes (>= 3 clonal abnormalities); monosomal karyotypes
• FOR PATIENTS IN STAGE 2 (ENROLLED PATIENT #18 AND BEYOND)
• >= 55 years of age with AML of any risk classification, or 18-54 years of age with intermediate or high risk AML as defined by National Comprehensive Cancer Network (NCCN) risk assignment

Exclusion Criteria

• STAGES 1 AND 2
• Patients with acute promyelocytic leukemia (APL) as diagnosed by morphologic criteria, flow cytometric characteristics, and rapid cytogenetics or fluorescence in situ hybridization (FISH) or molecular testing
• Any previous treatment with vosaroxin
• Concomitant chemotherapy, radiation therapy
• For patients with hyperleukocytosis with > 50,000 blasts/μL; leukapheresis or hydroxyurea may be used prior to study drug administration for cytoreduction at the discretion of the treating physician
• Active, uncontrolled infection
• Patients with infection under active treatment and controlled with antibiotics, antivirals, or antifungals are eligible
• Chronic hepatitis is acceptable
• Active, uncontrolled graft vs. host disease (GVHD) following allogeneic transplant for non-AML condition (e.g. MDS, lymphoid malignancy, aplastic anemia); patients with GVHD controlled on stable doses of immunosuppressants are eligible
• Presence of other life-threatening illness
• Left ventricular ejection fraction (LVEF) < 40% as measured by echocardiogram or multi gated acquisition scan (MUGA)
• Known or suspected central nervous system (CNS) involvement of active AML
• Other active malignancies including other hematologic malignancies or other malignancies within 12 months before randomization, except nonmelanoma skin cancer or cervical intraepithelial neoplasia
• History of myocardial infarction (MI), unstable angina, cerebrovascular accident, or transient ischemic attack (CVA/TIA) within 3 months before randomization
• Prior or current therapy:
• Hydroxyurea or medications to reduce blast count within 24 hours before randomization
• Treatment with an investigational product within 14 days before randomization, or not recovered from all acute effects of previously administered investigational products
• Renal insufficiency requiring hemodialysis or peritoneal dialysis
• Pregnant or breastfeeding
• Known human immunodeficiency virus (HIV) seropositivity
• Any other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the investigator or medical monitor
• ADDITIONAL EXCLUSION CRITERIA APPLIED TO STAGE 1
• Patients 18-54 years of age w