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A Randomized, Open-label, Controlled, Phase 2 Study of Pevonedistat, Venetoclax, and Azacitidine Versus Venetoclax Plus Azacitidine in Adults With Newly Diagnosed Acute Myeloid Leukemia Who Are Unfit for Intensive Chemotherapy

Trial Profile

A Randomized, Open-label, Controlled, Phase 2 Study of Pevonedistat, Venetoclax, and Azacitidine Versus Venetoclax Plus Azacitidine in Adults With Newly Diagnosed Acute Myeloid Leukemia Who Are Unfit for Intensive Chemotherapy

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 25 Jun 2025

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At a glance

  • Drugs Pevonedistat (Primary) ; Azacitidine; Azacitidine; Venetoclax
  • Indications Acute myeloid leukaemia
  • Focus Therapeutic Use
  • Acronyms PEVENAZA
  • Sponsors Takeda; Takeda Oncology

Most Recent Events

  • 23 Jun 2025 Planned End Date changed from 31 Mar 2025 to 23 Jun 2025.
  • 01 Mar 2025 Primary endpoint (Event-Free Survival (EFS)) has not been met, as per results published in the Leukemia and Lymphoma.
  • 01 Mar 2025 Status changed from active, no longer recruiting to discontinued (stopped early following negative results from PANTHER, which evaluated pevonedistat in higher-risk myelodysplastic syndromes/chronic myelomonocytic leukemia or low-blast AML).

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