A Randomized, Double-Blind, Placebo Controlled Study of Venetoclax Co-Administered with Low Dose Cytarabine Versus Low Dose Cytarabine in Treatment Naïve Patients with Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513630-37-00

Acronym

M16-043

Enrollment

Registered

2024-07-01

Start date

2017-10-24

Completion date

2025-06-23

Last updated

2024-07-01

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

Overall Survival (OS)

Detailed description

CR + CRi rate, CR + CRi rate by initiation of Cycle 2., Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Fatigue Short Form [SF] 7a., Global Health Status/Quality of Life (GHS/QoL) based on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30)

Interventions

DRUGVenetoclax

DRUGCytarabine 100 mg/ml Solution for Injection or Infusion

DRUGMatching Placebo for Venetoclax

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall Survival (OS)	—

Secondary

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

Countries

France

Outcome results

None listed

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