NGS MRD-Guided Blinatumomab Treatment for Pediatric B-ALL

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?

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Key information

Conditions

B Cell Precursor Acute Lymphoblastic Leukemia Minimal Residual Disease Neoplasm, Residual Neoplasms Neoplastic Processes Next Generation Sequencing (NGS) Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatric

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

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.

Primary outcomes

event free survival

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

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.
Relapse free survival

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

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.

Secondary outcomes

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaojun Xu

CONTACT

[email protected]

+86-571-88873450

Sponsors and collaborators

Lead sponsor

The Children's Hospital of Zhejiang University School of Medicine

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2030
First posted: Jan 8, 2025
Registry last updated: Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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