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

Launched by ABBVIE · Aug 8, 2018

Keywords

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Gender

ALL

Eligibility criteria

• 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.