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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05837689

Enrollment

Registered

2023-05-01

Start date

2023-04-30

Completion date

2023-04-30

Last updated

2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia, Pediatric

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.

Interventions

DRUGBlinatumomab

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
MRD clearance rate (MRD<0.00001%)	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026