A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

Open to people ages 18 years and up

• Subject should have an established, confirmed diagnosis of Acute Myeloid Leukemia (AML) by World Health Organization (2016).
• Subject should have failed at least 1 line of prior therapy (defined as failure to respond to therapy, and/or progression during or after therapy).
• Subject should have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• Subject should have adequate hematologic, kidney and liver function as described in the protocol.
• For subjects enrolling into the Expansion Cohort only: a documented FMS-like Tyrosine Kinase (FLT3) mutation in bone marrow or peripheral blood, as described in the protocol.

• Subject has a diagnosis of acute promyelocytic leukemia (APL) or BCR-ABL-positive leukemia.
• Subject has a history of other malignancies within 2 years prior to study entry, with exceptions as described in the protocol.
• Subject has active central nervous system leukemia.
• Subject has a history of chronic New York Heart Association (NYHA) class IV heart failure.
• Subject has a corrected QT interval of > 450 ms.
• Subject has a chronic respiratory disease that requires continuous oxygen use.