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
Latest Information Update: 22 Jul 2024
At a glance
- Drugs Azacitidine (Primary) ; Azacitidine (Primary) ; Venetoclax (Primary)
- Indications Acute myeloid leukaemia; Myeloproliferative disorders
- Focus Registrational; Therapeutic Use
- Acronyms VIALE-A
- Sponsors AbbVie; AbbVie Germany; Roche
- 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
- 12 Dec 2023 Results of pooled analysis, evaluating the outcomes of Ven+Aza across elderly age cohorts in patients with ND AML from NCT02203773 and Ven+Aza versus Pbo+Aza in patients with ND AML who were IC-ineligible from NCT02993523, presented at the 65th American Society of Hematology Annual Meeting and Exposition