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

A Multicenter, Open-Label Phase 1b Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

A dose-escalation study evaluating the safety, tolerability, pharmacokinetics (PK) and efficacy of venetoclax, in combination with gilteritinib, in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML) who have failed to respond to, and/or have relapsed or progressed after at least 1 prior therapy.

Inclusion Criteria:

• Should have an established, confirmed diagnosis of Acute Myeloid Leukemia (AML) by World Health Organization (2016).
• Should have failed at least 1 line of prior therapy (defined as failure to respond to therapy, and/or progression during or after therapy).
• Should have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• Should have adequate hematologic, kidney and liver function as described in the protocol.
• For participants 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.

Exclusion Criteria:

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