NCT06852222

A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

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 KMT2A Rearrangements or NPM1 Mutations Who Are Ineligible for Intensive Chemotherapy

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess how bleximenib and Venetoclax (VEN)+ Azacitidine (AZA) works as compared to placebo and VEN+AZA alone for the treatment of participants with newly diagnosed Acute Myeloid Leukemia (AML) with a mutation in the NPM1 or KMT2A gene.

Conditions

• Leukemia, Myeloid, Acute

Interventions

Type	Name	Description
DRUG	Bleximenib	Bleximenib will be administered orally.
DRUG	Venetoclax (VEN)	VEN will be administered orally.
DRUG	Azacitidine (AZA)	AZA will be administered intravenously or subcutaneously.
DRUG	Placebo	Placebo will be administered orally.

Timeline

• Start date: 2025-06-04
• Primary completion: 2029-06-22
• Completion: 2029-08-15
• First posted: 2025-02-28
• Last updated: 2026-04-13

Locations

239 sites across 24 countries: United States, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Mexico, Poland, Portugal, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study