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NCT Number: NCT06607419

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

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.

Recruiting

Interested in participating?

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Key information

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Anhui Provincial Children's Hospital, Hefei, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 and accept the informed consent approved by the Ethics Committee

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 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%.

Treatment and study plan

Blinatumomab

Drug

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

Primary outcomes

  1. The flow cytometric MRD

    Time frame: From the date of Blinatumomab completion to one week after its treatment course

    The flow cytometric MRD negative (<0.01%) rate at the end of induction for patients received Blinatumomab will superior to historical control (D46MRD in the CCCG-ALL2020 protocol)

  2. The NGS- MRD

    Time frame: From the date of Blinatumomab completion to one week after its treatment course

    The NGS- MRD negative (<0.0001%) rate at the end of induction for patients received Blinatumomab will superior to historical control (D46MRD in the CCCG-ALL2020 protocol)

Secondary outcomes

  1. 5-year EFS

    Time frame: 5 years since the last recruited patient completed Blinatumomab.

    The 5-year EFS of study group was significantly higher than that of the control group.

  2. Adverse events

    Time frame: From day 19 of induction therapy until the start of the second high-dose methotrexate regimen.

    Comparison of adverse events in study and control groups

  3. Healthcare costs

    Time frame: Six-month since window phase

    Comparison of healthcare costs in study and control groups

Other outcomes

  1. Effects of Blinatumomab on immune function

    Time frame: From the day of or before Blinatumomab to 3-7 days after termination of Blinatumomab.

    Immune cell subgroup, T-cell activation, depletion, and cytokine releasing will be studied before Blinatumomab and day 7 and day 14 during Blinatumomab, and 1 week after Blinatumomab discontinuation.

Study contacts

Contact information is provided by the study sponsor or research team.

Shuhong Shen, PhD/MD

CONTACT

[email protected]

86-18930830638

Wenting Hu, MD

CONTACT

[email protected]

13524836748

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Collaborators

  • Anhui Provincial Children's Hospital
  • Dalian Women and Children's Medical Center
  • Fujian Maternity and Child Health Hospital
  • Guizhou Provincial People's Hospital
  • Hunan Provincial People's Hospital
  • Jiangxi Province Children's Hospital
  • Ningbo Women & Children's Hospital
  • The First Affiliated Hospital of Xiamen University
  • The Third Xiangya Hospital of Central South University
  • Yuying Children's Hospital of Wenzhou Medical University
  • Zhangzhou Affiliated Hospital of Fujian Medical University

Registry information

Acronym: BBClean

Important dates

Study start
2024
Primary completion
2025
Study completion
2030
First posted
Sep 23, 2024
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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