The primary objective of this study is to evaluate the efficacy of blinatumomab.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Administered via CIVI
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Childrens Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Wuhan Childrens Hospital
Wuhan, Hubei, China
Number of Participants with Complete Remission (CR)
Time frame: Up to 84 days
Number of Participants with CR with Partial Recovery of Peripheral Blood Counts (CRh)
Time frame: Up to 84 days
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 240 days
Number of Participants with Serious TEAEs
Time frame: Up to approximately 2 years
Number of Participants with Treatment-related TEAEs
Time frame: Up to approximately 240 days
Number of Participants with Adverse Events of Interest
Time frame: Up to approximately 240 days
Steady State Concentration (Css) of Blinatumomab
Time frame: Days 3, 8, 9 and 29
Clearance of Blinatumomab
Time frame: Days 3, 8, 9 and 29
Overall Survival (OS) Rate
Time frame: Up to approximately 2 years
Relapse-Free Survival (RFS) Rate
Time frame: Up to approximately 2 years
Number of Participants who Receive Allogeneic Hematopoietic Stem Cell Transplant (alloHSCT)
Time frame: Up to approximately 2 years
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Children's Hospital of Soochow University
Suzhou, Jiangsu, China
Shanghai Children's Medical Center
Shanghai, Shanghai Municipality, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
100-day Mortality Rate After alloHSCT
Time frame: Up to approximately 2 years
Number of Participants with Anti-blinatumomab Antibody (ADA) Formation
Time frame: Up to approximately 240 days
Minimal Residual Disease (MRD) Response
Time frame: Up to 84 days