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Brief Title: A Phase 3 Clinical Study to Evaluate Lemzoparlimab for Injection in Combination With Azacitidine (AZA) Versus AZA Monotherapy in Treatment-naïve Patients With Higher-risk Myelodysplastic Syndrome (MDS)
Official Title: A Randomized, Controlled, Open-label, Multicenter Phase 3 Clinical Study to Evaluate Lemzoparlimab for Injection in Combination With Azacitidine (AZA) Versus AZA Monotherapy in Treatment-naïve Patients With Higher-risk Myelodysplastic Syndrome (MDS)
Study ID: NCT05709093
Brief Summary: This phase3 study is a randomized, controlled, open-label, multicenter study to evaluate the efficacy and safety of Lemzoparlimab for injection in combination with AZA versus AZA monotherapy as first-line therapy in treatment-naïve subjects with intermediate- and high-risk MDS.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The First Affiliated Hospital Of Bengbu Medical College, Bengbu, An Hui, China
THE First Affiliated Hospital Of Anhui Medical University, Hefei, An Hui, China
The First Affilated Hospital Of USTC Anhui Provincial Hospital, Hefei, Anhui, China
Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, Bei Jing, China
Beijing Gaobo Boren Hospital Co., Ltd, Beijing, Bei Jing, China
Peking University Third Hospital, Beijing, Bei Jing, China
The First Affiliated Hospital of PLA Army Military Medical University, Chongqing, Chong Qing, China
The Second Affiliated Hospital of Army Medical University, Chongqing, Chong Qing, China
The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chong Qing, China
The Affiliated Zhongshan Hospital of Xiamen University, Xiamen, Fu Jian, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guang Dong, China
Zhujiang Hospital of Southern Medical University, Guangzhou, Guang Dong, China
Southern Hospital of Southern Medical University, Guangzhou, Guang Dong, China
Guangdong Provincial People's Hospital, Guangzhou, Guang Dong, China
Shenzhen Second People's Hospital, Shenzhen, Guang Dong, China
First Affiliated Hospital of Henan University of Science and Technology, Luoyang, He Nan, China
Henan Cancer Hospital, Zhengzhou, He Nan, China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, He Nan, China
Henan Provincial People's Hospital, Zhengzhou, He Nan, China
Harbin First Hospital, Harbin, Hei Long Jiang, China
Tongji Medical College of HUST, Wuhan, Hu Bei, China
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China
Changsha Third Hospital, Changsha, Hunan, China
The first hospital of Jilin University, Chang chun, Ji Lin, China
The Affiliated Hosptial Of XuZhou Medical University, Xuzhou, Jiang Su, China
The First Affiliated Hospital of Nanchang University, Nanchang, Jiang XI, China
The First Affiliated Hospital of China Medical University, Shenyang, Liaoning, China
Shaanxi Provincial People's Hospital, Xian, Shaan XI, China
The Second Affiliated Hospital of Xi'an Jiaotong University Medical College, Xi'an, Shaanxi, China
Cheeloo College of Medicine, Shandong University, Jinan, Shan Dong, China
The Affiliated Hospital of Medical College Qingdao University, Qingdao, Shan Dong, China
The Second Affiliated Hospital of Shandong First Medical University, Tai'an, Shan Dong, China
Taian City Central Hospital, Taian, Shan Dong, China
Shanxi Bethune Hospital, Taiyuan, Shan XI, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, Shang Hai, China
Tongji Hospital of Tongji University, Shanghai, Shang Hai, China
Renji Hospital Affiliated to Medical College of Shanghai Jiaotong University, Shanghai, Shang Hai, China
Shanghai Sixth People's Hospital, Shanghai, Shanghai, China
West China Hospital of Sichuan University, Chengdu, Si Chuan, China
West China Hospital of Sichuan University, Chengdu, Si Chuan, China
Affiliated Hospital of North Sichuan Medical College, Nanchong, Si Chuan, China
Tianjin Medical University General Hospital, Tianjin, Tian Jin, China
Hematology Hospital of Chinese Academy of Medical Sciences, Tianjin, Tianjin, China
The First Affiliated Hospital of Zhejiang University Medical College, Hangzhou, Zhe Jiang, China
The First Affiliated Hospital Of WenZhou Medical College, Wenzhou, Zhejiang, China