CClinicalTrials.gg
Status unknownNCT05837689Updated May 1, 2023

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

An observational study in Acute Lymphoblastic Leukemia, Pediatric, sponsored by Xiaojun Xu. Status unknown. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2023-05-01.

Sponsored by Xiaojun Xu · Observational

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
20
Ages
1 Year to 18 Years
Sex
All
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Study 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.

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Conditions studied

  • Acute Lymphoblastic Leukemia, Pediatric
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In context

Precursor Cell Lymphoblastic Leukemia-Lymphoma

2,061 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 490 are open to participants now.

This study's planned enrollment of 20 is below the median of 120 across 300 observational studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.

Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →

Lead sponsor

This is the only study on the registry with Xiaojun Xu as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pediatric BCP-ALL patients who were treated in our institution since Oct 2021

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

Exclusion Criteria:

  • Patients without data of NGS detection after receiving blinatumomab treatment
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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
20 participants (estimated)
Patient registry
No

Interventions

  • DrugBlinatumomab

    IV

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What researchers measure

Primary outcomes

  1. 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

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05837689
Lead sponsor
Xiaojun Xu
Responsible party
Xiaojun Xu (Principal investigator, The Children's Hospital of Zhejiang University School of Medicine) — Sponsor-investigator
First posted
May 1, 2023
Start date
Apr 2023 (estimated)
Primary completion
Apr 2023 (estimated)
Completion
Apr 2023 (estimated)
Last update
May 1, 2023

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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