Vanderbilt-Ingram Cancer Center

Patients are being asked to take part in this research study because they have first relapsed or refractory acute myeloid leukemia (AML). Relapsed means the leukemia has come back after treatment. Refractory means that the leukemia never or only briefly (for less than 3 months) responded to treatment.

Criteria
 Inclusion Criteria:

 • Provide signed, written informed consent

 • Are at least 18 years of age

 • Have a diagnosis of AML according to World Health Organization (WHO) classification

 • First relapsed or refractory AML (refractory to initial induction therapy)

 • Have an ECOG score of 0-2

 • Have adequate liver and renal function as indicated by certain laboratory values

 • Are nonfertile or agree to use an adequate method of contraception until 30 days after the last treatment

 Exclusion Criteria:

 • Have received more than 2 cycles of induction therapy for AML

 • Refractory to or relapsed within the previous 3 months after therapy with an IDAC- or HIDAC-containing regimen

 • Have received a hematopoietic stem cell transplant (HSCT) within the previous 3 months

 • Have received active immunosuppressive therapy for graft-versus-host disease (GVHD) within 2 weeks before study start

 • Have any other severe concurrent disease, or have a history of serious disease involving the heart, kidney, liver, or other organ system

 • Have evidence of central nervous system involvement of active AML

 • Have other active malignancies (including other hematologic malignancies) or been diagnosed with other malignancies within the last 12 months, except nonmelanoma skin cancer or cervical intraepithelial neoplasia

 • Have an active, uncontrolled infection

 • Are receiving any other investigational therapy

 • Have received previous treatment with vosaroxin

 • Are pregnant or lactating

 • Have any other medical, psychological, or social condition that may interfere with consent, study participation, or follow-up