{Reference Type}: Journal Article
{Title}: Design of the VIALE-M phase III trial of venetoclax and oral azacitidine maintenance therapy in acute myeloid leukemia.
{Author}: Ivanov V;Yeh SP;Mayer J;Saini L;Unal A;Boyiadzis M;Hoffman DM;Kang K;Addo SN;Mendes WL;Fathi AT;Ivanov V;Yeh SP;Mayer J;Saini L;Unal A;Boyiadzis M;Hoffman DM;Kang K;Addo SN;Mendes WL;Fathi AT;Ivanov V;Yeh SP;Mayer J;Saini L;Unal A;Boyiadzis M;Hoffman DM;Kang K;Addo SN;Mendes WL;Fathi AT;
{Journal}: Future Oncol
{Volume}: 18
{Issue}: 26
{Year}: Aug 2022
{Factor}: 3.674
{DOI}: 10.2217/fon-2022-0450
{Abstract}: 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).