About this trial
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.
Eligibility criteria
Qualifiers
Age older than 1 month to younger than 18 years.
Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.
Immunophenotyping: acute B-lymphoblastic leukemia;
Subjects in the sytudy group or their guardians must be able to understand and accept the informed consent approved by the Ethics Committee
Disqualifiers
sIgM+;
ALL evolved from chronic myeloid leukemia (CML);
Down's syndrome, or major congenital or hereditary disease with organ dysfunction;
Other secondary leukemias;
Trial design
Treatments tested in this trial
- Blinatumomab
Treatment groups
Sponsors and collaborators
Shanghai Jiao Tong University School of Medicine
Lead sponsor
Fujian Maternity and Child Health Hospital
Collaborator
Zhangzhou Affiliated Hospital of Fujian Medical University
Collaborator
Guizhou Provincial People's Hospital
Collaborator
The First Affiliated Hospital of Xiamen University
Collaborator
Dalian Women and Children's Medical Center
Collaborator
The Third Xiangya Hospital of Central South University
Collaborator
Hunan Provincial People's Hospital
Collaborator
Ningbo Women & Children's Hospital
Collaborator
Anhui Provincial Children's Hospital
Collaborator
Jiangxi Province Children's Hospital
Collaborator
Yuying Children's Hospital of Wenzhou Medical University
Collaborator