If you are interested in learning more about your possible participation in this clinical trial, please complete the form. Your information will be forwarded directly to the sponsoring company.
- Age ≥ 60 years with relapsed/refractory AML of any type except for acute promyelocytic leukemia (APL; AML M3), after at least 1 prior AML therapy , who have never undergone, and who are not currently eligible for, stem cell transplantation, and are currently deemed unfit for intensive chemotherapy.
- ECOG ≤ 2.
- Must have available archival or recently acquired bone marrow biopsy/aspiration or tumor tissue for central review to be eligible.
- Relapsed or refractory AML, defined as either: recurrence of disease after a complete remission (CR), or failure to achieve CR with initial therapy.
- Must have received at least 1 prior line of AML therapy given at standard doses and must have progressed after most recent therapy. Prior therapy must have included a hypomethylating agent with at least 2 cycles.
- Treatment with any investigational agent within 3 weeks prior to first dose in this study.
- Presence of central nervous system (CNS) leukemia.
- In blast transformation of chronic myeloid leukemia (CML). Prior myelodysplastic syndrome (MDS) is acceptable; prior treatment for MDS does not count as an AML therapy.
- Major surgery within 2 weeks of first dose of study drug. Patients must have recovered from the effects of any surgery performed greater than 2 weeks previously.
- Concurrent active malignancy under treatment.
- Known active hepatitis B virus (HBV) or C virus (HCV) infection; or known to be positive for HCV ribonucleic acid (RNA) or HBsAg (HBV surface antigen).
- Known HIV infection.
- Unable to swallow tablets, or patients with malabsorption syndrome, or any other disease significantly affecting gastrointestinal function.
- Patients whose AML is classified as favorable according to the European LeukemiaNet (ELN) disease risk assessment.