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

Study acronym: cAMeLot-2
StatusRecruiting
PhasePhase 3
Started2025-06-04
View on ClinicalTrials.gov ↗
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.

Amendment history 4 changes detected by DataLookout

2026-08-29
Trial sites expanded: 257 → 262 locations
2026-08-01
Trial sites expanded: 253 → 257 locations
2026-07-07
Trial sites expanded: 250 → 253 locations
2026-05-09
Trial sites expanded: 239 → 248 locations
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 2026-08-28