Multicenter, Phase 3 Study of Venetoclax and Azacitidine as Maintenance Therapy for Patients With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy
Latest Information Update: 01 Jul 2025
At a glance
- Drugs Azacitidine (Primary) ; Azacitidine (Primary) ; Azacitidine (Primary) ; Venetoclax (Primary)
- Indications Acute myeloid leukaemia
- Focus Adverse reactions; Registrational
- Acronyms VIALE-M
- Sponsors AbbVie
Most Recent Events
- 25 Jun 2025 Planned End Date changed from 1 May 2025 to 1 Jun 2026.
- 25 May 2025 Planned End Date changed from 30 Apr 2025 to 1 May 2025.
- 06 Jul 2023 Efficacy end-point "Relapse-Free Survival (RFS) (Part 3 Randomization Portion)" is removed from the primary end points thus removing "TU" from trial focus.