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

被引：20

作者：

Ivanov, Vladimir ^{[1
]}

Yeh, Su-Peng ^{[2
]}

Mayer, Jiri ^{[3
,4
]}

Saini, Lalit ^{[5
]}

Unal, Ali ^{[6
]}

Boyiadzis, Michael ^{[7
]}

Hoffman, David M. ^{[8
]}

Kang, Kingston ^{[8
]}

Addo, Sadiya N. ^{[8
]}

Mendes, Wellington L. ^{[8
]}

Fathi, Amir T. ^{[9
]}

机构：

[1] Almazov Natl Med Res Ctr, St Petersburg, Russia

[2] China Med Univ Hosp, Taichung, Taiwan

[3] Fak Nemocnice Brno, Brno, Czech Republic

[4] Masaryk Univ, Brno, Czech Republic

[5] London Hlth Sci Ctr, London, ON, Canada

[6] Erciyes Univ, Sch Med, Kayseri, Turkey

[7] Genentech Inc, San Francisco, CA USA

[8] AbbVie Inc, N Chicago, IL USA

[9] Harvard Med Sch, Massachusetts Gen Hosp, Boston, MA 02115 USA

来源：

FUTURE ONCOLOGY | 2022年 / 18卷 / 26期

关键词：

acute myeloid leukemia; BCL-2; inhibitor; CC-486 (oral azacitidine); first remission; maintenance therapy; minimal residual disease conversion; phase III; relapse-free survival; venetoclax; QUALITY-OF-LIFE; HEMATOPOIETIC-CELL TRANSPLANTATION; CONVENTIONAL CARE REGIMENS; LOW-DOSE CYTARABINE; OLDER PATIENTS; COMPLETE REMISSION; ELDERLY-PATIENTS; POSTREMISSION TREATMENT; TREATMENT OUTCOMES; BCL-2; INHIBITION;

D O I：

10.2217/fon-2022-0450

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页码：2879 / 2889

页数：11

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