A Randomized, Double-blind, Placebo Controlled Phase 3 Study of Venetoclax in Combination with Azacitidine Versus Azacitidine in Treatment Naïve Subjects with Acute Myeloid Leukemia who are Ineligible for Standard Induction Therapy, Incorporating Extension Period - Continued Access for Venetoclax. (VIALE-A)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513631-25-00

Acronym

M15-656

Enrollment

Registered

2024-07-15

Start date

2017-08-17

Completion date

2025-09-15

Last updated

2025-09-18

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

Conditions

Acute Myeloid Leukemia

Brief summary

Rate of complete remission (CR) or complete remission with incomplete marrow recovery (CRi), Overall Survival (OS)

Detailed description

Event-Free Survival (EFS), CR + CRi rate by the initiation of Cycle 2, Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Fatigue Short Form [SF] 7a and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core [EORTC QLQ-C30]).

Interventions

DRUGVenetoclax

DRUGMatching Placebo for Venetoclax

DRUGAZACITIDINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Rate of complete remission (CR) or complete remission with incomplete marrow recovery (CRi), Overall Survival (OS)	—

Secondary

Measure	Time frame
Event-Free Survival (EFS), CR + CRi rate by the initiation of Cycle 2, Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Fatigue Short Form [SF] 7a and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core [EORTC QLQ-C30]).	—

Countries

Belgium, Czechia, Finland, France, Hungary, Spain

Outcome results

None listed

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