Publication details
Design of the VIALE-M phase III trial of venetoclax and oral azacitidine maintenance therapy in acute myeloid leukemia
| Authors | |
|---|---|
| Year of publication | 2022 |
| Type | Article in Periodical |
| Magazine / Source | Future Oncology |
| MU Faculty or unit | |
| Citation | |
| Web | https://www.futuremedicine.com/doi/10.2217/fon-2022-0450 |
| Doi | http://dx.doi.org/10.2217/fon-2022-0450 |
| Keywords | acute myeloid leukemia; BCL-2 inhibitor; CC-486 (oral azacitidine); first remission; maintenance therapy; minimal residual disease conversion; phase III; relapse-free survival; venetoclax |
| Description | 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. |