Clinical trial · Interventional
NGS MRD-Guided Blinatumomab Treatment for Pediatric B-ALL
NCT06763302CI-TRIAL-00084459not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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?
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B Cell Precursor Acute Lymphoblastic Leukemia | — | UNRESOLVED | — |
| Minimal Residual Disease | — | UNRESOLVED | — |
| Next Generation Sequencing (NGS) | — | UNRESOLVED | — |
| Pediatric | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blinatumomab | Drug | Blinatumomab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- EOC NGS MRD positive 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.
- interventionNames
- Drug: Blinatumomab
- type
- ACTIVE_COMPARATOR
- label
- EOC NGS MRD negative Group A
- 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.
- interventionNames
- Drug: Blinatumomab
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDChen H, Gu M, Liang J, Song H, Zhang J, Xu W, Zhao F, Shen D, Shen H, Liao C, Tang Y, Xu X. Minimal residual disease detection by next-generation sequencing of different immunoglobulin gene rearrangements in pediatric B-ALL. Nat Commun. 2023 Nov 17;14(1):7468. doi: 10.1038/s41467-023-43171-9. PMID 37978187