NGS MRD-Guided Blinatumomab Treatment for Pediatric B-ALL

Not Applicable

Not yet recruiting

• Conditions: B Cell Precursor Acute Lymphoblastic Leukemia; Pediatric; Minimal Residual Disease; Next Generation Sequencing (NGS)
• Interventions: Drug: Blinatumomab

• Registration Number: NCT06763302
• Lead Sponsor: The Children's Hospital of Zhejiang University School of Medicine

Brief 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?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-23
• Status Verified: 2025-01
• Study Start: 2025-01-01
• Study First Submitted QC: 2025-01-02
• Last Update Submitted: 2025-01-02
• Study First Posted: 2025-01-08
• Last Update Posted: 2025-01-08
• Primary Completion: 2027-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EOC NGS MRD positive Group	Blinatumomab	Based on the B-ALL treatment protocol, NGS MRD levels will be monitored at the end of consolidation treatment (EOC). If NGS MRD is positive (≥0.0001%), one course of blinatumomab (28 days) will be added after the consolidation treatment.
EOC NGS MRD negative Group A	Blinatumomab	Based on the B-ALL treatment protocol, NGS MRD levels will be monitored at the end of consolidation treatment (EOC). If NGS MRD is negative (\< 0.0001%), the IR/HR patients will be randomized into A and B two groups. EOC NGS MRD negative Group A will be added by one course of blinatumomab (28 days) treatment after the consolidation treatment.

Primary Outcome Measures

Name	Time	Method
event free survival	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	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 Outcome Measures

Name	Time	Method
Treatment-Related Adverse Events as Assessed by CTCAE v4.0	From enrollment to the 3-year after the end of treatment