| Inclusion Criteria: | 1) Able to understand and provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization, as appropriate
2) At least 18 years of age
3) Diagnosis of acute myeloid leukemia (AML) by World Health Organization (WHO) classification
4) First relapsed or refractory AML with at least 5% blasts by bone marrow biopsy or aspirate, or at least 1% blasts in peripheral blood, and meeting the following criteria:MUST MEET (a), (b), and (c). (a) First relapse occurred at least 90 days to 24 months after the first CR or CRp; (b) The first CR or CRp had to result from no more than 2 cycles of cytotoxic chemotherapy. At least 1 induction cycle must have consisted of an anthracycline (or anthracenedione) and cytarabine combination with a reasonable schedule/dose of anthracycline in the judgment of the investigator; (c) The re-emergence of at least 5% leukemic blasts in bone marrow is not attributable to other causes, regardless of new or recurrent dysplastic changes or extramedullary disease, or the re-emergence of at least 1% blasts in the peripheral blood is not attributable to other causes such as regenerating marrow.
5) Continued from #4: The date of relapse is the date of the first bone marrow examination that demonstrated the re-emergence of at least 5% leukemic blasts, or is the date of the first peripheral blood test that demonstrated at least 1% blasts not attributable to other causes such as regenerating marrow. Allowed: Unlimited cycles/regimens of consolidation for first CR or CRp Transplantation for AML (allogeneic or autologous) allowed unless within 90 days of randomization Maintenance therapy with hypomethylating or biologic agents until relapse.
6) Continued from #5: REFRACTORY MUST MEET EITHER (e) and (g) OR (f) and (g): (e) Persistent AML was documented by bone marrow biopsy or aspirate at least 28 days after day 1 of the first induction cycle of 1 or 2 cycles of cytotoxic chemotherapy; (f) Re-emergence of at least 5% leukemic blasts in bone marrow or at least 1% blasts in peripheral blood is not attributable to other causes such as regenerating marrow, and was less than 90 days after the first CR or CRp; (g) Prior induction therapy had to include no more than 2 cycles of cytotoxic chemotherapy. At least 1 induction cycle must have consisted of an anthracycline (or anthracenedione) and cytarabine combination with a reasonable schedule/dose of anthracycline in the judgment of the investigator.
7) Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
8) Local clinical laboratory values as follows: Serum creatinine </= 2.0 mg/dL; Total bilirubin </= 1.5 x the upper limit of normal (ULN), unless due to Gilbert's syndrome; Aspartate aminotransferase (AST) </= 2.5 x ULN; Alanine aminotransferase (ALT) </= 2.5 x ULN.
9) Left ventricular ejection fraction (LVEF) at least 40% by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO)
10) Clinically significant nonhematologic toxicity after prior chemotherapy has recovered to grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 or newer
11) Females must be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months) or if of childbearing potential, must have a negative urine or serum pregnancy test within 14 days before randomization, and must agree to use an adequate method of contraception during the study until 30 days after the last treatment. Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 30 days after the last treatment |