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NGS MRD-Guided Blinatumomab Treatment for Pediatric B-ALL

NCT06763302 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1220

Last updated 2025-01-08

No results posted yet for this study

Summary

The goal of this clinical trial is to determine whether pediatric B-cell acute lymphoblastic leukemia (B-ALL) patients with negative deep minimal residue disease (MRD) can benefit from blinatumomab treatment.

The main questions it aims to answer are:

1. Whether the application of blinatumomab can improve the long-term survival of next generation sequence (NGS) MRD-positive B-ALL children after consolidation therapy?
2. Whether the application of blinatumomab can benefit the NGS MRD-negative B-ALL children after consolidation therapy?

Conditions

  • B Cell Precursor Acute Lymphoblastic Leukemia
  • Pediatric
  • Minimal Residual Disease
  • Next Generation Sequencing (NGS)

Interventions

DRUG

Blinatumomab

The FDA has approved blinatumomab for post-consolidation treatment in all Ph-negative B-ALL cases, regardless of MRD status. Considering the high cost of blinatumomab and the financial burden on families, we aim to precisely identify the population who would benefit from blinatumomab and provide appropriate treatment.

Sponsors & Collaborators

  • The Children's Hospital of Zhejiang University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2027-12-31
Completion
2030-12-31

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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 NCT06763302 on ClinicalTrials.gov