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

NCT06607419 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-09-23

No results posted yet for this 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.

Conditions

  • B-Cell Lymphoblastic Leukemia

Interventions

DRUG

Blinatumomab

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

Sponsors & Collaborators

  • Fujian Children's Hospital

    collaborator UNKNOWN

  • Zhangzhou Affiliated Hospital of Fujian Medical University

    collaborator OTHER

  • Guizhou Provincial People's Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Xiamen University

    collaborator OTHER

  • Dalian Women and Children's Medical Center

    collaborator UNKNOWN

  • The Third Xiangya Hospital of Central South University

    collaborator OTHER

  • Hunan Provincial People's Hospital

    collaborator OTHER

  • Ningbo Women & Children's Hospital

    collaborator OTHER

  • Anhui Provincial Children's Hospital

    collaborator OTHER

  • Jiangxi Province Children's Hospital

    collaborator OTHER

  • Yuying Children's Hospital of Wenzhou Medical University

    collaborator OTHER

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-21
Primary Completion
2025-05-31
Completion
2030-05-31
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06607419 on ClinicalTrials.gov