| IVANOV, Vladimir, Su-Peng YEH, Jiří MAYER, Lalit SAINI, Ali UNAL, Michael BOYIADZIS, David M HOFFMAN, Kingston KANG, Sadiya N ADDO, Wellington L MENDES and Amir T FATHI. Design of the VIALE-M phase III trial of venetoclax and oral azacitidine maintenance therapy in acute myeloid leukemia. Future Oncology. London: Future Medicine Ltd., 2022, vol. 18, No 26, p. 2879-2889. ISSN 1479-6694. Available from: https://dx.doi.org/10.2217/fon-2022-0450. |
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@article{2247606,
author = {Ivanov, Vladimir and Yeh, SuandPeng and Mayer, Jiří and Saini, Lalit and Unal, Ali and Boyiadzis, Michael and Hoffman, David M and Kang, Kingston and Addo, Sadiya N and Mendes, Wellington L and Fathi, Amir T},
article_location = {London},
article_number = {26},
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},
language = {eng},
issn = {1479-6694},
journal = {Future Oncology},
title = {Design of the VIALE-M phase III trial of venetoclax and oral azacitidine maintenance therapy in acute myeloid leukemia},
url = {https://www.futuremedicine.com/doi/10.2217/fon-2022-0450},
volume = {18},
year = {2022}
}
TY - JOUR
ID - 2247606
AU - 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
PY - 2022
TI - Design of the VIALE-M phase III trial of venetoclax and oral azacitidine maintenance therapy in acute myeloid leukemia
JF - Future Oncology
VL - 18
IS - 26
SP - 2879-2889
EP - 2879-2889
PB - Future Medicine Ltd.
SN - 14796694
KW - acute myeloid leukemia
KW - BCL-2 inhibitor
KW - CC-486 (oral azacitidine)
KW - first remission
KW - maintenance therapy
KW - minimal residual disease conversion
KW - phase III
KW - relapse-free survival
KW - venetoclax
UR - https://www.futuremedicine.com/doi/10.2217/fon-2022-0450
N2 - 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.
ER -
IVANOV, Vladimir, Su-Peng YEH, Jiří MAYER, Lalit SAINI, Ali UNAL, Michael BOYIADZIS, David M HOFFMAN, Kingston KANG, Sadiya N ADDO, Wellington L MENDES and Amir T FATHI. Design of the VIALE-M phase III trial of venetoclax and oral azacitidine maintenance therapy in acute myeloid leukemia. \textit{Future Oncology}. London: Future Medicine Ltd., 2022, vol.~18, No~26, p.~2879-2889. ISSN~1479-6694. Available from: https://dx.doi.org/10.2217/fon-2022-0450.
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