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

Last updated: September 20, 2024
Sponsor: Shanghai Jiao Tong University School of Medicine
Overall Status: Active - Recruiting

Phase

2/3

Condition

Leukemia

Treatment

Blinatumomab

Clinical Study ID

NCT06607419
CBC-ALL2024-1
  • Ages 1-18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 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 andaccept the informed consent approved by the Ethics Committee

Exclusion

Exclusion Criteria:

  • 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 dayswithin one month before enrollment, or any chemotherapy or radiotherapy within 3months before enrollment (except for emergency radiotherapy to relieve airwaycompression);

  • Initial diagnosis of high risk;

  • D46MRD ≥1%.

Study Design

Total Participants: 90
Treatment Group(s): 1
Primary Treatment: Blinatumomab
Phase: 2/3
Study Start date:
May 21, 2024
Estimated Completion Date:
May 31, 2030

Connect with a study center

  • Anhui Provincial Children's Hospital

    Hefei, Anhui 230051
    China

    Site Not Available

  • Fujian Children's Hospital

    Fuzhou, Fujian 350011
    China

    Site Not Available

  • Shanghai Children's Medical center

    Shanghai, Shanghai 200127
    China

    Active - Recruiting

  • Ningbo Women and Children's Hospital

    Ningbo, Zhejiang 315012
    China

    Active - Recruiting

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