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A Randomized, Double-Blind, Placebo Controlled Phase 3 Study of Venetoclax Co-Administered With Low Dose Cytarabine Versus Low Dose Cytarabine in Treatment Naive Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

Trial Profile

A Randomized, Double-Blind, Placebo Controlled Phase 3 Study of Venetoclax Co-Administered With Low Dose Cytarabine Versus Low Dose Cytarabine in Treatment Naive Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 24 Mar 2025

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At a glance

  • Drugs Venetoclax (Primary) ; Cytarabine
  • Indications Acute myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms VIALE-C
  • Sponsors AbbVie; AbbVie Germany

Most Recent Events

  • 27 Jun 2024 Planned End Date changed from 18 Jul 2024 to 18 Jul 2025.
  • 27 Jun 2023 Planned End Date changed from 20 Jul 2023 to 18 Jul 2024.
  • 15 Jun 2023 Results (n=401 from studies NCT02993523, NCT02203773, NCT03069352, andNCT02287233) assessing dysregulation of the integrated stress response (ISR) pathway in pts with TP53mut, specificallythrough the actions of DAP3 binding cell death enhancer 1 (DELE1) and its activating protease OMA1 presented at the 28th Congress of the European Haematology Association

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