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A Randomized, Double-blind, Placebo Controlled Phase 3 Study of Venetoclax in Combination with Azacitidine Versus Azacitidine in Treatment Naïve Subjects with Acute Myeloid Leukemia who are Ineligible for Standard Induction Therapy, Incorporating Extension Period - Continued Access for Venetoclax. (VIALE-A) - M15-656

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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 Naïve Subjects with Acute Myeloid Leukemia who are Ineligible for Standard Induction Therapy, Incorporating Extension Period - Continued Access for Venetoclax. (VIALE-A) - M15-656

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

Latest Information Update: 18 Jun 2026

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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

  • 11 Jun 2026 Planned End Date changed from 23 Jan 2026 to 15 Jun 2026.
  • 11 Jun 2026 Status changed from completed to active, no longer recruiting.
  • 15 May 2026 Status changed from active, no longer recruiting to completed.

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