详情页 - 聚合机构库演示平台

当前位置：首页 > 详情页

A Safety and Efficacy Study of Oral Venetoclax Tablets and Injectable Azacitidine Versus Best Supportive Care as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy to Evaluate Improvement in Relapse-Free Survival

77| 认领 | 链接全文 |

文献详情

编号/登记号：

注册时间：

研究开始时间：

研究结束时间：

项目类型：

本院角色：

多中心研究：

招募状态：

试验分期：

研究疾病/适应症：

研究类型：

研究参与人：

研究单位： [1]AbbVie [2]Henan Cancer Hospital /ID# 215566 Zhengzhou, Henan, China, 450008 [3]Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 218046 Wuhan, Hubei, China, 430022 [4]The First Hospital of Jilin University /ID# 215560 Changchun, Jilin, China, 130021 [5]The First Hospital of China Medical University /ID# 216285 Shenyang, Liaoning, China, 110001

关键词： Acute myeloid leukemia (AML) Venetoclax Azacitidine CC-486 Maintenance Therapy Conventional Chemotherapy Best supportive care (BSC)

研究目的：

This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose (RPTD) of venetoclax in combination with AZA. Part 3 will be conducted in 2 phases - Dose Finding portion to determine RPTD of venetoclax in combination with CC-486 and Randomization portion to evaluate if venetoclax in combination with CC-486 as maintenance therapy improves relapse-free survival (RFS) compared to CC-486.