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).
- MeSH
- akutní myeloidní leukemie * MeSH
- azacytidin škodlivé účinky MeSH
- bicyklické sloučeniny heterocyklické MeSH
- buněčné dělení MeSH
- klinické zkoušky, fáze III jako téma MeSH
- lidé MeSH
- protokoly antitumorózní kombinované chemoterapie * škodlivé účinky MeSH
- randomizované kontrolované studie jako téma MeSH
- sulfonamidy MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
