研究单位:[1]Pfizer[2]Peking University First Hospital,Beijing,Beijing,China,100034[3]Peking University Third Hospital,Beijing,Beijing,China,100091[4]Fujian Medical University Union Hospital,Fuzhou,Fujian,China,350000[5]Guangzhou First People's Hospital,Guangzhou,Guangdong,China,510180[6]NanFang Hospital of Southern Medical University,Guangzhou,Guangdong,China,510515[7]SUN Yat-Sen University Cancer Center,Guangzhou,Guangdong,China,510700[8]The First Hospital of Harbin,Harbin,Heilongjiang,China,150010[9]Henan Cancer Hospital,Zhengzhou,Henan,China,450008[10]Union Hospital, Tongji Medical College of Huazhong University of Science & Technology,Wuhan,Hubei,China,430022[11]Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology,Wuhan,Hubei,China,430030[12]Wuhan Tongji Hospital,Wuhan,Hubei,China,430030[13]The First Affiliated Hospital of Soochow University,Suzhou,Jiangsu,China,215006[14]The First Hospital of Jilin University,Changchun,Jilin,China,130021[15]West China Hospital of Sichuan University,Chengdu,Sichuan,China,610041[16]Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences,Tianjin,Tianjin,China,300020[17]Tianjin Medical University General Hospital,Tianjin,Tianjin,China,300052[18]Tianjin Medical University General Hospital,Tianjin,Tianjin,China,300052[19]The first Affiliated Hospital, Zhejiang University School of Medicine,Hangzhou,Zhejiang,China,310003[20]The First Affiliated Hospital of Wenzhou Medical College,Wenzhou,Zhejiang,China,325000
研究目的:
This is an open-label, single-arm, multicenter study in Chinese patients with relapsed or refractory CD22-positive B-cell ALL. The objective of the study is to confirm the efficacy, safety, and PK of inotuzumab ozogamicin in patients with relapsed or refractory B-cell ALL from mainland China.