Design of the VIALE-M phase III trial of venetoclax and oral azacitidine maintenance therapy in acute myeloid leukemia
| Autoři | |
|---|---|
| Rok publikování | 2022 |
| Druh | Článek v odborném periodiku |
| Časopis / Zdroj | Future Oncology |
| Fakulta / Pracoviště MU | |
| Citace | |
| www | https://www.futuremedicine.com/doi/10.2217/fon-2022-0450 |
| Doi | http://dx.doi.org/10.2217/fon-2022-0450 |
| Klíčová slova | acute myeloid leukemia; BCL-2 inhibitor; CC-486 (oral azacitidine); first remission; maintenance therapy; minimal residual disease conversion; phase III; relapse-free survival; venetoclax |
| Popis | 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. |