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A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of Venetoclax in Combination with Azacitidine Versus Azacitidine in Treatment Naive Subjects with Acute Myeloid Leukemia who are Ineligible for Standard Induction Therapy

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Trial Profile

A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of Venetoclax in Combination with Azacitidine Versus Azacitidine in Treatment Naive Subjects with Acute Myeloid Leukemia who are Ineligible for Standard Induction Therapy

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

Latest Information Update: 12 Feb 2025

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At a glance

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

Most Recent Events

  • 29 Sep 2024 This trial has been completed in Austria according to European Clinical Trials Database record.
  • 27 Jun 2024 Planned End Date changed from 25 Sep 2024 to 23 Jan 2026.
  • 01 Apr 2024 Long-term follow-up data of VIALE-A published in the American Journal of Hematology

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