A Randomized, Double-Blind, Phase 3 Study Evaluating the Safety and Efficacy of Venetoclax in Combination with Azacitidine in Patients Newly Diagnosed with Higher-Risk Myelodysplastic Syndrome (Higher-Risk MDS)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507153-16-00

Acronym

M15-954

Enrollment

186

Registered

2023-12-12

Start date

2020-11-18

Completion date

Unknown

Last updated

2025-07-16

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

Conditions

Higher-Risk Myelodysplastic Syndrome

Brief summary

The primary endpoint of this study is Overall Survival.

Detailed description

Modified overall response (mOR) defined as complete remission (CR) + partial remission (PR) + marrow CR (mCR), Overall hematological improvement (HI) (platelet, neutrophil, or erythroid), Complete remission, Red blood cell (RBC) and platelet transfusion independence for subjects who are transfusion dependent on RBC and/or platelet at baseline, Time to deterioration in physical functioning, as measured by the physical functioning domain of EORTC QLQ-C30, Change from baseline in fatigue, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue SF 7a, Overall response (OR) defined as CR + PR

Interventions

DRUGVidaza 25 mg/ml powder for suspension for injection

DRUGVenetoclax

DRUGPlacebo Venetoclax/ABT-199/Film-coated tablet Oral Use

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this study is Overall Survival.	—

Secondary

Measure	Time frame
Modified overall response (mOR) defined as complete remission (CR) + partial remission (PR) + marrow CR (mCR), Overall hematological improvement (HI) (platelet, neutrophil, or erythroid), Complete remission, Red blood cell (RBC) and platelet transfusion independence for subjects who are transfusion dependent on RBC and/or platelet at baseline, Time to deterioration in physical functioning, as measured by the physical functioning domain of EORTC QLQ-C30, Change from baseline in fatigue, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue SF 7a, Overall response (OR) defined as CR + PR	—

Measure

Time frame

—

Countries

Austria, Belgium, Czechia, France, Germany, Italy, Netherlands, Poland, Spain

Outcome results

None listed

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