B Cell Precursor Acute Lymphoblastic Leukemia, Minimal Residual Disease, Next Generation Sequencing (NGS), Pediatric
Conditions
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?
Interventions
DRUGBlinatumomab
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.
Sponsors
The Children's Hospital of Zhejiang University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Treatment-Related Adverse Events as Assessed by CTCAE v4.0 | From enrollment to the 3-year after the end of treatment |
Contacts
Primary ContactXiaojun Xu
Outcome results
None listed