Design of the VIALE-M phase III trial of venetoclax and oral azacitidine maintenance therapy in acute myeloid leukemia
Language English Country Great Britain, England Media print-electronic
Document type Journal Article, Review
Grant support
AbbVie
PubMed
35852098
DOI
10.2217/fon-2022-0450
Knihovny.cz E-resources
- Keywords
- BCL-2 inhibitor, CC-486 (oral azacitidine), acute myeloid leukemia, first remission, maintenance therapy, minimal residual disease conversion, phase III, relapse-free survival, venetoclax,
- MeSH
- Leukemia, Myeloid, Acute * MeSH
- Azacitidine adverse effects MeSH
- Bridged Bicyclo Compounds, Heterocyclic MeSH
- Cell Division MeSH
- Clinical Trials, Phase III as Topic MeSH
- Humans MeSH
- Antineoplastic Combined Chemotherapy Protocols * adverse effects MeSH
- Randomized Controlled Trials as Topic MeSH
- Sulfonamides MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Review MeSH
- Names of Substances
- Azacitidine MeSH
- Bridged Bicyclo Compounds, Heterocyclic MeSH
- Sulfonamides MeSH
- venetoclax MeSH Browser
Prevention of relapse is a major therapeutic challenge and an unmet need for patients with acute myeloid leukemia (AML). Venetoclax is a highly selective, potent, oral BCL-2 inhibitor that induces apoptosis in AML cells. When combined with azacitidine, it leads to prolonged overall survival and rapid, durable remissions in treatment-naive AML patients ineligible for intensive chemotherapy. VIALE-M is a randomized, double-blind, two-arm study to evaluate the safety and efficacy of venetoclax in combination with oral azacitidine (CC-486) as maintenance therapy in patients in complete remission with incomplete blood count recovery after intensive induction and consolidation therapies. The primary end point is relapse-free survival. Secondary outcomes include overall survival, minimal residual disease conversion and improvement in quality-of-life. Trial Registration Number: NCT04102020 (ClinicalTrials.gov).
AbbVie Inc North Chicago IL USA
Almazov National Medical Research Centre Saint Petersburg Russian Federation
China Medical University Hospital Taichung City Taiwan
Erciyes University Medical School Kayseri Turkey
Fakultni Nemocnice Brno and Masaryk University Brno Czechia
Genentech Inc San Francisco CA USA
London Health Sciences Center ON Canada
Massachusetts General Hospital Harvard Medical School Boston MA USA
References provided by Crossref.org
ClinicalTrials.gov
NCT04102020
