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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age1-18
SponsorShanghai Jiao Tong University School of Medicine

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

90 Participants
are divided into 1 treatment group

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