Health TrialsbyHealthPanel

NGS MRD-Guided Blinatumomab Treatment for Pediatric B-ALL

ConditionsB Cell Precursor Acute Lymphoblastic LeukemiaPediatricMinimal Residual DiseaseNext Generation Sequencing (NGS)
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Blinatumomab

    Drug

    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.

Treatment groups

1,220 Participants
are divided into 3 treatment groups
Group A: EOC NGS MRD positive GroupExperimental treatment 1 intervention
Group B: EOC NGS MRD negative Group AActive comparator 1 intervention
Group C: EOC NGS MRD negative Group BNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

event free survival

Death during induction, abandonment before complete remission, death in continuous complete remission, relapse, and secondary Death during induction, abandonment before complete remission (CR), death in continuous complete remission (CCR), relapse, and secondary malignancies were considered as events in the calculation of EFS probability.

Time frame
From enrollment to the 3-year after the end of treatment
2

Relapse free survival

RFS was measured by the time from achievement of CR to last follow-up or first relapse and censored at the first event (death, secondary malignancies) except relapse.

Time frame
From enrollment to the 3-year after the end of treatment

Secondary outcomes

1

Treatment-Related Adverse Events as Assessed by CTCAE v4.0

Time frame
From enrollment to the 3-year after the end of treatment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Children's Hospital of Zhejiang University School of Medicine

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: