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Randomized Study to Assess Revumenib in Combination With Azacitidine + Venetoclax in Adult Patients With Newly Diagnosed NPM1-mutated or KMT2A-rearranged AML Ineligible for Intensive Chemotherapy

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Trial Profile

Randomized Study to Assess Revumenib in Combination With Azacitidine + Venetoclax in Adult Patients With Newly Diagnosed NPM1-mutated or KMT2A-rearranged AML Ineligible for Intensive Chemotherapy

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 12 May 2025

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At a glance

  • Drugs Azacitidine (Primary) ; Revumenib (Primary) ; Venetoclax (Primary)
  • Indications Acute myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms EVOLVE-2
  • Sponsors Syndax Pharmaceuticals

Most Recent Events

  • 05 May 2025 According to a Syndax media release, this trial is being conducted in collaboration with the HOVON network, a leading cooperative clinical trial group with extensive experience studying novel therapies for hematologic malignancies.
  • 30 Apr 2025 According to a Syndax Pharmaceuticals media release, company completed the submission of a supplemental New Drug Application (sNDA) to the U.S. FDA in April 2025, seeking Priority Review for the approval of Revuforj for the treatment of R/R mutant NPM1 (mNPM1) AML.
  • 04 Apr 2025 Status changed from not yet recruiting to recruiting.

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