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)

Sponsor ID
20190359
Clinicaltrials.gov ID
NCT06054113
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The primary objective of this study is to evaluate the efficacy of blinatumomab.

Additional Study Details

Phase
Phase 2
Product
blinatumomab
Type
Interventional
Masking
None (Open Label)
Enrollment
18
Additional Study Details

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
Status
Contact Us
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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