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

J 2022

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

IVANOV, Vladimir; Su-Peng YEH; Jiří MAYER; Lalit SAINI; Ali UNAL et. al.

Basic information

Original name

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

Authors

IVANOV, Vladimir (guarantor); Su-Peng YEH; Jiří MAYER (203 Czech Republic, belonging to the institution); Lalit SAINI; Ali UNAL; Michael BOYIADZIS; David M HOFFMAN; Kingston KANG; Sadiya N ADDO; Wellington L MENDES and Amir T FATHI

Edition

Future Oncology, London, Future Medicine Ltd. 2022, 1479-6694

Other information

Language

English

Type of outcome

Article in a journal

Field of Study

30205 Hematology

Country of publisher

United Kingdom of Great Britain and Northern Ireland

Confidentiality degree

is not subject to a state or trade secret

References:

URL

Impact factor

Impact factor: 3.300

RIV identification code

RIV/00216224:14110/22:00128095

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.2217/fon-2022-0450

UT WoS

000827070200001

EID Scopus

2-s2.0-85135596293

Keywords in English

acute myeloid leukemia; BCL-2 inhibitor; CC-486 (oral azacitidine); first remission; maintenance therapy; minimal residual disease conversion; phase III; relapse-free survival; venetoclax

Abstract

V originále

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.

Cite

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.

@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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