Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnosed Pediatric B Lymphoblastic Leukemia
Status:
RECRUITING
Trial end date:
2030-05-31
Target enrollment:
Participant gender:
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.
Phase:
PHASE2
Details
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Collaborators:
Anhui Provincial Children's Hospital Dalian Women and Children's Medical Center Fujian Children's Hospital Guizhou Provincial People's Hospital Hunan Provincial People's Hospital Jiangxi Province Children's Hospital Ningbo Women & Children's Hospital The First Affiliated Hospital of Xiamen University The Third Xiangya Hospital of Central South University Yuying Children's Hospital of Wenzhou Medical University Zhangzhou Affiliated Hospital of Fujian Medical University