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

• Status: Completed
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Collaborators: Astellas Pharma Inc; Genentech, Inc.
• Treatments: Venetoclax

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.