RecruitingPhase 2Phase 3NCT06607419

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


Sponsor

Shanghai Jiao Tong University School of Medicine

Enrollment

90 participants

Start Date

May 21, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 MonthMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding blinatumomab — a drug that directs the immune system to attack leukemia cells — can eliminate early residual disease in children with newly diagnosed B-cell acute lymphoblastic leukemia (B-ALL) who still have trace amounts of cancer after initial treatment. **You may be eligible if...** - Your child is between 1 month and 18 years old - They have been diagnosed with B-cell acute lymphoblastic leukemia (B-ALL) confirmed by bone marrow biopsy and immune testing - After initial treatment, residual leukemia cells (MRD) were still detectable at specific cutoff levels (depending on risk group) - The child or guardian is able to understand and sign informed consent **You may NOT be eligible if...** - The leukemia has a specific surface marker (sIgM+) or arose from chronic myeloid leukemia - The child has Down syndrome or significant genetic/organ abnormalities - There is active central nervous system involvement - There is a history of epilepsy or recent seizures - The child has a known immune deficiency Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBlinatumomab

Recruited patients will receive Blinatumomab since day 29 of induction for 14 days.


Locations(4)

Anhui Provincial Children's Hospital

Hefei, Anhui, China

Fujian Children's Hospital

Fuzhou, Fujian, China

Shanghai Children's Medical center

Shanghai, Shanghai Municipality, China

Ningbo Women and Children's Hospital

Ningbo, Zhejiang, China

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NCT06607419


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