NGS MRD-Guided Blinatumomab Treatment for Pediatric B-ALL

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-18
SponsorThe Children's Hospital of Zhejiang University School of Medicine

About this trial

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?

Eligibility criteria

Qualifiers

Clincial dianogsis of acute lymphoblastic leukemia (B-cell type) by morphology, immunology, cytogenetics, and molecular biology (MICM).

Age ≥1 year and <18 years.

Informed consent signed, with the parents or guardians agreeing to a unified treatment protocol.

Disqualifiers

Age <1 year or ≥18 years.

Immunophenotyping suggests mature B-cell leukemia, mixed-lineage leukemia, or T-cell acute lymphoblastic leukemia.

Secondary leukemia or second tumor, CML blast phase ALL.

Other tumors or immunodeficiency diseases present.

Trial design

Treatments tested in this trial

  • Blinatumomab

Treatment groups

1,220 Participants
are divided into 3 treatment groups

Locations

This trial has no locations