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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

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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: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Oct 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

  • 20 Aug 2025 Status changed from active, no longer recruiting to completed.
  • 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.

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