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
Latest Information Update: 24 Mar 2025
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