A Phase 3 Randomized, Double-blind, Placebo-controlled, Study of Bleximenib, Venetoclax and Azacitidine for the Treatment of Participants with Newly Diagnosed Acute Myeloid Leukemia Harboring KMT2ARearrangements or NPM1Mutations who are Ineligible for Intensive Chemotherapy

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-520154-38-00

Acronym

75276617AML3001

Enrollment

246

Registered

2025-07-11

Start date

2025-07-29

Completion date

Unknown

Last updated

2025-10-17

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

Conditions

Acute Myeloid Luekemia

Brief summary

Dual primary endpoints: CR and OS

Interventions

DRUGJNJ-75276617

DRUGVenclyxto 100 mg film-coated tablets

DRUGAzacitidine betapharm 25 mg/mL powder for suspension for injection

DRUGmatching the 50 mg (G029)

DRUGVenclyxto 50 mg film-coated tablets

DRUGmatching the 100 mg (G030)

DRUGmatching the 30 mg (G031)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Dual primary endpoints: CR and OS	—

Countries

Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Poland, Portugal, Spain

Outcome results

None listed

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