Multicenter, Phase 3 Study of Venetoclax and Azacitidine as Maintenance Therapy for Patients with Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy (VIALE-M)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507221-42-00

Acronym

M19-708

Enrollment

Registered

2024-02-06

Start date

2020-06-03

Completion date

Unknown

Last updated

2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia in First Remission

Brief summary

Part I: The primary endpoint is dose-limiting toxicities of venetoclax in combination with AZA, Part III (Dose Finding): The primary endpoint is DLTs of venetoclax in combination with oral AZA, Part III (Randomization): Not applicable; Part 3 (Randomization) was removed from Version 6.0 of this protocol.

Detailed description

Part 3 (Randomization): Not applicable; Part 3 (Randomization) was removed from Version 6.0 of this protocol.

Interventions

DRUGVenetoclax

DRUGAZACITIDINE

DRUGazacitidine

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Part I: The primary endpoint is dose-limiting toxicities of venetoclax in combination with AZA, Part III (Dose Finding): The primary endpoint is DLTs of venetoclax in combination with oral AZA, Part III (Randomization): Not applicable; Part 3 (Randomization) was removed from Version 6.0 of this protocol.	—

Secondary

Measure	Time frame
Part 3 (Randomization): Not applicable; Part 3 (Randomization) was removed from Version 6.0 of this protocol.	—

Countries

Czechia, France, Germany, Greece, Hungary, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026