NGS MRD-Guided Blinatumomab Treatment for Pediatric B-ALL
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blinatumomab.
- Who it may be relevant to
- Registry conditions: B Cell Precursor Acute Lymphoblastic Leukemia, Pediatric, Minimal Residual Disease, Next Generation Sequencing (NGS). Basic parameters: 1 year — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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?
Interventions
- Drug Blinatumomab
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 outcome measures
- event free survival [Time frame: From enrollment to the 3-year after the end of treatment]
- Relapse free survival [Time frame: From enrollment to the 3-year after the end of treatment]
Secondary outcome measures (1)
- Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [Time frame: From enrollment to the 3-year after the end of treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Chen 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
Identifiers
NCT: NCT06763302 · 2024-IRB-0307-P-01