A Study of Oral Venetoclax Tablets and Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy (VIALE-M)

AbbVie

Status and phase: Active, not recruiting; Phase 3

Conditions: Acute Myeloid Leukemia (AML)

Treatments: Drug: Venetoclax; Drug: Azacitidine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04102020

M19-708

2023-507221-42-00 (Other Identifier)

Details and patient eligibility

About

This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose (RPTD) of venetoclax in combination with azacitidine (AZA). Part 3 will be the Dose Finding portion to determine RPTD of venetoclax in combination with AZA. Part 2 and Part 3 Randomization of the study were removed.

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of newly diagnosed acute myeloid leukemia (AML).

• Participant meets the following disease activity criteria:

  • Confirmation of AML by World Health Organization (WHO) criteria (2016) and have confirmed complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following completion of intensive induction and consolidation chemotherapies.
  • Achieved first CR + CRi within 120 days of first dose of study drug or be no more than 75 days since last dose of intensive conventional (including both induction and consolidation) chemotherapies.
  • AML has intermediate or poor risk cytogenetics per National Comprehensive Cancer Network (NCCN) 2016 criteria.

• Eastern Cooperative Oncology Group (ECOG) performance status <= 2.

• Participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol.

Exclusion criteria

• History of acute promyelocytic leukemia (APL).
• History of active central nervous system involvement with acute myeloid leukemia (AML).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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112 participants in 3 patient groups

Part 1: Dose Confirmation

Experimental group

Description:

Participants will receive venetoclax once daily (QD) (Days 1-28) for up to 24 cycles, azacitidine (AZA) QD on Days 1-5 of each 28 day cycle for up to 6 cycles.

Treatment:

Drug: Azacitidine

Drug: Azacitidine

Drug: Venetoclax

Part 3 (Dose Finding): Dose Escalation

Experimental group

Description:

Participants will receive venetoclax QD for up to 24 cycles, AZA QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles to determine recommended phase 3 dose (RPTD).

Treatment:

Drug: Azacitidine

Drug: Azacitidine

Drug: Venetoclax

Part 3 (Dose Finding): Safety Expansion

Experimental group

Description:

Participants will receive venetoclax QD for up to 24 cycles, AZA QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles at the RPTD.

Treatment:

Drug: Azacitidine

Drug: Azacitidine

Drug: Venetoclax