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

AbbVie

Status and phase: Completed; Phase 1

Conditions: Acute Myeloid Leukemia (AML)

Treatments: Drug: Venetoclax; Drug: Gilteritinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03625505

M16-802

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

Dose Escalation Venetoclax + Gilteritinib

Experimental group

Description:

Different combinations of dose levels for venetoclax in combination with gilteritinib will be administered to determine the recommended phase 2 dose (RPTD).

Treatment:

Drug: Gilteritinib

Drug: Venetoclax

Dose Expansion Venetoclax + Gilteritinib

Experimental group

Description:

Participants will receive venetoclax in combination with gilteritinib at the dose determined in dose escalation portion.

Treatment:

Drug: Gilteritinib

Drug: Venetoclax