Recruitment Complete
Sponsor ID
20190359
Study of Blinatumomab Administration in Chinese Pediatric Participants with Relapsed/Refractory B precursor Acute Lymphoblastic Leukemia (R/R B-ALL)
Study Details
The primary objective of this study is to evaluate the efficacy of blinatumomab.
Protocol Summary
Primary Outcome Measures
Number of Participants with Complete Remission (CR)
Timeframe: Up to 84 days
Number of Participants with CR with Partial Recovery of Peripheral Blood Counts (CRh)
Timeframe: Up to 84 days
Secondary Outcome Measures
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to approximately 240 days
Number of Participants with Serious TEAEs
Timeframe: Up to approximately 2 years
Number of Participants with Treatment-related TEAEs
Timeframe: Up to approximately 240 days
Number of Participants with Adverse Events of Interest
Timeframe: Up to approximately 240 days
Steady State Concentration (Css) of Blinatumomab
Timeframe: Days 3, 8, 9 and 29
Clearance of Blinatumomab
Timeframe: Days 3, 8, 9 and 29
Overall Survival (OS) Rate
Timeframe: Up to approximately 2 years
Relapse-Free Survival (RFS) Rate
Timeframe: Up to approximately 2 years
Number of Participants who Receive Allogeneic Hematopoietic Stem Cell Transplant (alloHSCT)
Timeframe: Up to approximately 2 years
100-day Mortality Rate After alloHSCT
Timeframe: Up to approximately 2 years
Number of Participants with Anti-blinatumomab Antibody (ADA) Formation
Timeframe: Up to approximately 240 days
Minimal Residual Disease (MRD) Response
Timeframe: Up to 84 days
Locations
Location
Shanghai Children's Medical Center
Shanghai, Shanghai, China, 200127
Status
Recruiting
Location
Children's Hospital of Soochow University
Suzhou, Jiangsu, China, 215002
Status
Recruiting
Location
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin, China, 300020
Status
Recruiting
Location
Childrens Hospital of Chongqing Medical University
Chongqing, Chongqing, China, 400015
Status
Recruiting
Location
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510280
Status
Recruiting
Location
The Second Hospital of Anhui Medical University
Hefei, Anhui, China, 230601
Status
Recruiting
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