drugset
drugset / Trial / NCT06852222

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

NCT06852222 ↗

Phase 3 Recruiting 600 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2025-06-04
Primary completion
2029-06-22
Completion
2029-08-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified — Intravenous
Subject Bleximenib Small molecule — Oral
Subject Venetoclax Small molecule — Oral

Indications

acute myeloid leukemia