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

Study acronym: BBClean
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 23, 2024 (before its estimated May 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
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.
Trial Details
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
(from sponsor)		 B-Cell Lymphoblastic Leukemia
Related terms Burkitt Lymphoma
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov