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

September 20, 2024 updated by: Shuhong Shen, Shanghai Jiao Tong University School of Medicine

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230051
        • Not yet recruiting
        • Anhui Provincial Children's Hospital
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350011
        • Not yet recruiting
        • Fujian Children's Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Shanghai Children's Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shuhong Shen, PhD/MD
        • Sub-Investigator:
          • Wenting Hu, MD
        • Sub-Investigator:
          • Changcheng Chen, MD
    • Zhejiang
      • Ningbo, Zhejiang, China, 315012
        • Recruiting
        • Ningbo Women and Children's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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%.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Blinatumomab
Patients in this group should receive Blinatumomab
Drug: Blinatumomab
Recruited patients will receive Blinatumomab since day 29 of induction for 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From the date of Blinatumomab completion to one week after its treatment course
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)
From the date of Blinatumomab completion to one week after its treatment course

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years since the last recruited patient completed Blinatumomab.
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
From day 19 of induction therapy until the start of the second high-dose methotrexate regimen.
Healthcare costs
Time Frame: Six-month since window phase
Comparison of healthcare costs in study and control groups
Six-month since window phase

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the day of or before Blinatumomab to 3-7 days after termination of Blinatumomab.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2024

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

May 31, 2030

Study Registration Dates

First Submitted

September 4, 2024

First Submitted That Met QC Criteria

September 20, 2024

First Posted (Actual)

September 23, 2024

Study Record Updates

Last Update Posted (Actual)

September 23, 2024

Last Update Submitted That Met QC Criteria

September 20, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBC-ALL2024-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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