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:
Active, no longer recruiting
Phase of Trial:
Phase III
Latest Information Update: 05 Jul 2023
Price :
$35
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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
- 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
- 01 Oct 2022 Results from VIALE-A and VIALE-C; assessing impact of use of Post-Remission Granulocyte Colony-Stimulating Factor, published in the Clinical Lymphoma, Myeloma & Leukemia