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Trial Title:
Minimal Residual Disease Quantification by Next-generation Sequencing in Pediatric B-ALL Children Patients Treated With Blinatumomab Consolidation
NCT ID:
NCT05837689
Condition:
Acute Lymphoblastic Leukemia, Pediatric
Conditions: Official terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasm, Residual
Blinatumomab
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Drug
Intervention name:
Blinatumomab
Description:
IV
Summary:
A retrospective analysis to investigate pediatric B-cell acute lymphoblastic leukemia
patients who were treated with blinatumomab for consolidation, and who were detected as
minimal residual disease (MRD) positive by next generation sequencing (NGS). The efficacy
of blinatumomab clearing MRD detected by NGS will be analyzed, in order to see the
potential of using NGS to guide MRD eradication by blinatumomab.
Criteria for eligibility:
Study pop:
Pediatric BCP-ALL patients who were treated in our institution since Oct 2021
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Patients diagnosed with B cell precursor acute lymphoblastic leukemia
- Patients who received blinatumomab for consolidation
- Patients who were detected MRD positive by NGS before initiation of blinatumomab
treatment
Exclusion Criteria:
- Patients without data of NGS detection after receiving blinatumomab treatment
Gender:
All
Minimum age:
1 Year
Maximum age:
18 Years
Healthy volunteers:
No
Start date:
April 2023
Completion date:
April 2023
Lead sponsor:
Agency:
Xiaojun Xu
Agency class:
Other
Source:
The Children's Hospital of Zhejiang University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05837689
