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Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnosed Pediatric B Lymphoblastic Leukemia
Sponsor: Shanghai Jiao Tong University School of Medicine
Summary
The goal of this clinical trial is to evaluate the efficacy of Blinatumomab in pediatric patient with newly diagnosed acute B-Lymphoblastic leukemia with poor response to early chemotherapy, i.e. day 19 MRD ≥ 0.1% (low-risk) or day 19 MRD ≥ 0.01% (intermediate-risk). The main question is: • If the flow cytometric MRD negative (\<0.01%) rate and the NGS- MRD negative (\<0.0001%) rate at the end of induction for patients received Blinatumomab will be superior to historical control (D46MRD in the CCCG-ALL2020 protocol). Participants will: * Take 14 days full dose Blinatumomab; * With bone marrow evaluated before and after Blinatumomab treatment.
Key Details
Gender
All
Age Range
1 Month - 18 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2024-05-21
Completion Date
2030-05-31
Last Updated
2024-09-23
Healthy Volunteers
No
Conditions
Interventions
Blinatumomab
Recruited patients will receive Blinatumomab since day 29 of induction for 14 days.
Locations (4)
Anhui Provincial Children's Hospital
Hefei, Anhui, China
Fujian Children's Hospital
Fuzhou, Fujian, China
Shanghai Children's Medical center
Shanghai, Shanghai Municipality, China
Ningbo Women and Children's Hospital
Ningbo, Zhejiang, China