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

Recruiting now · Phase 2/Phase 3

Conditions studied: B-Cell Lymphoblastic Leukemia

In brief

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.

Key facts

Study ID

NCT06607419

Run by

Shanghai Jiao Tong University School of Medicine

People needed

90

Starts

2024-05-21

Expected to finish

2030-05-31

Last updated by the study team

2024-09-23

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age older than 1 month to younger than 18 years.
• Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.
• Immunophenotyping: acute B-lymphoblastic leukemia;
• Meet one of the following situations:
• A. Provisional low-risk: D19MRD ≥ 0.1%; B. Provisional intermediate-risk: D19MRD ≥ 0.01%;
• Subjects in the sytudy group or their guardians must be able to understand and accept the informed consent approved by the Ethics Committee

You may not qualify if…

• sIgM+;
• ALL evolved from chronic myeloid leukemia (CML);
• Down's syndrome, or major congenital or hereditary disease with organ dysfunction;
• Other secondary leukemias;
• CNS involvement;
• History of epilepsy; or convulsions within the last month;
• Known underlying congenital immunodeficiency or metabolic disease;
• Congenital heart disease with cardiac insufficiency;
• Treated with glucocorticoids for ≥14 days, or ABL kinase inhibitors for > 7 days within one month before enrollment, or any chemotherapy or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression);
• Initial diagnosis of high risk;
• D46MRD ≥1%.

Where it is running

• Shanghai Children's Medical center — Shanghai, Shanghai Municipality, China (enrolling)
• Ningbo Women and Children's Hospital — Ningbo, Zhejiang, China (enrolling)
• Anhui Provincial Children's Hospital — Hefei, Anhui, China
• Fujian Children's Hospital — Fuzhou, Fujian, China

Full record on ClinicalTrials.gov

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