Minimal Residual Disease Quantification by Next-generation Sequencing in Pediatric B-ALL Children Patients Treated With Blinatumomab Consolidation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Lymphoblastic Leukemia, Pediatric
- Sponsor
- Xiaojun Xu
- Enrollment
- 20
- Primary Endpoint
- MRD clearance rate (MRD<0.00001%)
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Xiaojun Xu
Principal investigator
The Children's Hospital of Zhejiang University School of Medicine
Eligibility 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
Outcomes
Primary Outcomes
MRD clearance rate (MRD<0.00001%)
Time Frame: before blinatumomab initiation (baseline), Day 15 of blinatumomab treatment, Day 29 of blinatumomab treatment
The change of MRD will be detected by NGS, with sensitivity of 0.00001% and 0.01%, respectively