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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

Trial Profile

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: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 06 May 2025

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At a glance

  • Drugs Azacitidine (Primary) ; Azacitidine (Primary) ; Bleximenib (Primary) ; Venetoclax (Primary)
  • Indications Acute myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms cAMeLot-2
  • Sponsors Janssen Research & Development

Most Recent Events

  • 27 Apr 2025 Planned initiation date changed from 2 May 2025 to 30 Apr 2025.
  • 04 Mar 2025 New trial record

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