Minimal Residual Disease Quantification by Next-generation Sequencing in Pediatric B-ALL Children Patients Treated With Blinatumomab Consolidation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- MRD clearance rate (MRD<0.00001%)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients without data of NGS detection after receiving blinatumomab treatment
结局指标
主要结局
MRD clearance rate (MRD<0.00001%)
时间窗: 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
次要结局
未报告次要终点
研究者
Xiaojun Xu
Principal investigator
The Children's Hospital of Zhejiang University School of Medicine