121
Participants
Start Date
October 18, 2017
Primary Completion Date
August 21, 2019
Study Completion Date
April 8, 2021
Blinatumomab
"Blinatumomab will be supplied as single-use glass injection vials as a sterile, preservative-free, white to off-white, lyophilized powder for reconstitution and administration by continuous intravenous infusion (CIVI).~A single cycle of blinatumomab treatment is 6 weeks in duration, which includes 4 weeks of blinatumomab CIVI followed by a 2 week treatment-free interval. The treatment-free interval may be prolonged by up to 7 days, if deemed necessary by the investigator."
Dexamthasone
Premedication with dexamethasone was intended to prevent cytokine release syndrome (CRS) events associated with blinatumomab treatment. Treatment could start pre-study. Dexamethasone 20 mg IV was administered within 3 hours before start of blinatumomab in each treatment cycle, and within 3 hours before dose step increase.
The Second Affiliated Hospital of Xi an Jiaotong University, Xi'an
Peking University Third Hospital, Beijing
Peking Union Medical College Hospital, Beijing
Chinese People Liberation Army General Hospital, Beijing
Peking University International Hosipital, Beijing
The First Hospital of China Medical University, Shenyang
The First Hospital of Jilin University, Changchun
Huashan Hospital Affiliated to Fudan University, Shanghai
Jiangsu Province Hospital, Nanjing
The First Affiliated Hospital of Soochow University, Suzhou
Anhui Provincial Hospital, Hefei
Institute of Hematology and Blood Diseases Hospital Peking Union Medical College, Tianjin
The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou
Second Affiliated Hospital Zhejiang University College of Medicine, Hangzhou
Fujian Medical University Union Hospital, Fuzhou
Xiangya Hospital Central South University, Changsha
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan
Henan Cancer Hospital, Zhengzhou
Guangdong Provincial Peoples Hospital, Guangzhou
The First Affiliated Hospital of Sun Yat-sen University, Guangzhou
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou
Nanfang Hospital, Southern Medical University, Guangzhou
West China Hospital, Sichuang University, Chengdu
Lead Sponsor
Amgen
INDUSTRY