Clinical Trial

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

Study acronym: cAMeLot-2
Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 changes
notable Trial sites expanded: 250 -> 253 locations 2026-07-07
notable Trial sites expanded: 239 -> 248 locations 2026-05-09
Trial Details
NCT Number NCT06852222
Lead Sponsor Janssen Research & Development, LLC
Conditions Leukemia, Myeloid, Acute
Enrollment 600 participants
Start Date 2025-06-04
Primary Completion 2029-06-22 (estimated)
Study Completion 2029-08-15 (estimated)
Updated on ClinicalTrials.gov 2026-07-06