Minimal Residual Disease Quantification by Next-generation Sequencing in Pediatric B-ALL Children Patients Treated With Blinatumomab Consolidation

Xiaojun Xu20 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Acute Lymphoblastic Leukemia, Pediatric

Interventions

BlinatumomabDRUG

Eligibility

Sex: ALLMin age: 1 YearMax age: 18 Years

Medical Language ↔ Plain English

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%)

The change of MRD will be detected by NGS, with sensitivity of 0.00001% and 0.01%, respectively

Time frame: before blinatumomab initiation (baseline), Day 15 of blinatumomab treatment, Day 29 of blinatumomab treatment

Data from ClinicalTrials.gov

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