Informace o publikaci

Design of the VIALE-M phase III trial of venetoclax and oral azacitidine maintenance therapy in acute myeloid leukemia

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IVANOV Vladimir YEH Su-Peng MAYER Jiří SAINI Lalit UNAL Ali BOYIADZIS Michael HOFFMAN David M KANG Kingston ADDO Sadiya N MENDES Wellington L FATHI Amir T

Rok publikování 2022
Druh Článek v odborném periodiku
Časopis / Zdroj Future Oncology
Fakulta / Pracoviště MU

Lékařská fakulta

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.

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