NGS MRD-Guided Blinatumomab Treatment for Pediatric B-ALL

Zhejiang University

Status: Not yet enrolling

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

Treatments: Drug: Blinatumomab

Study type: Interventional

Funder types: Other

Identifiers

NCT06763302

2024-IRB-0307-P-01

Details and patient eligibility

About

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?

Enrollment: 1,220 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,220 participants in 3 patient groups

EOC NGS MRD positive Group

Experimental group

Description:

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.

Treatment:

Drug: Blinatumomab

EOC NGS MRD negative Group A

Active Comparator group

Description:

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.

Treatment:

Drug: Blinatumomab

EOC NGS MRD negative Group B

No Intervention group

Description:

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 B will continue the original chemotherapy treatment plan.