Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnosed Pediatric B Lymphoblastic Leukemia

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.

NCT Number	NCT06607419
Lead Sponsor	Shanghai Jiao Tong University School of Medicine Collaborators: Fujian Maternity and Child Health Hospital, Zhangzhou Affiliated Hospital of Fujian Medical University, Guizhou Provincial People's Hospital, The First Affiliated Hospital of Xiamen University, Dalian Women and Children's Medical Center, The Third Xiangya Hospital of Central South University, Hunan Provincial People's Hospital, Ningbo Women & Children's Hospital, Anhui Provincial Children's Hospital, Jiangxi Province Children's Hospital, Yuying Children's Hospital of Wenzhou Medical University
Conditions	B-Cell Lymphoblastic Leukemia
Enrollment	90 participants
Start Date	2024-05-21
Primary Completion	2025-05-31 (estimated)
Study Completion	2030-05-31 (estimated)
Updated on ClinicalTrials.gov	2024-09-23