The trial is taking place at:
H

Hospital Universitario Virgen de la Victoria | Cardiology Department

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

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AbbVie

Status and phase

Active, not recruiting
Phase 3

Conditions

Acute Myeloid Leukemia (AML)

Treatments

Drug: CC-486
Drug: Venetoclax
Drug: Azacitidine

Study type

Interventional

Funder types

Industry

Identifiers

NCT04102020
M19-708
2019-002217-19 (EudraCT Number)

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 AZA. Part 3 will be the Dose Finding portion to determine RPTD of venetoclax in combination with CC-486. 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)

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 48 cycles, azacitidine (AZA) QD on Days 1-5 of each 28 day cycle for up to 6 cycles.
Treatment:
Drug: Azacitidine
Drug: Venetoclax
Part 3 (Dose Finding): Dose Escalation
Experimental group
Description:
Participants will receive venetoclax QD for up to 24 cycles, CC-486 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: Venetoclax
Drug: CC-486
Part 3 (Dose Finding): Safety Expansion
Experimental group
Description:
Participants will receive venetoclax QD for up to 24 cycles, CC-486 QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles at the RPTD.
Treatment:
Drug: Venetoclax
Drug: CC-486

Trial contacts and locations

158

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Data sourced from clinicaltrials.gov

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