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A Study of Inotuzumab Ozogamicin in Chinese Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

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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.

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