Minimal Residual Disease Quantification by Next-generation Sequencing in Pediatric B-ALL Children Patients Treated With Blinatumomab Consolidation
1 other identifier
observational
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2023
CompletedStudy Start
First participant enrolled
April 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedFirst Posted
Study publicly available on registry
May 1, 2023
CompletedMay 1, 2023
April 1, 2023
Same day
March 31, 2023
April 19, 2023
Conditions
Outcome Measures
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
before blinatumomab initiation (baseline), Day 15 of blinatumomab treatment, Day 29 of blinatumomab treatment
Interventions
IV
Eligibility Criteria
Pediatric BCP-ALL patients who were treated in our institution since Oct 2021
You may qualify if:
- 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
You may not qualify if:
- Patients without data of NGS detection after receiving blinatumomab treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xiaojun Xulead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
March 31, 2023
First Posted
May 1, 2023
Study Start
April 1, 2023
Primary Completion
April 1, 2023
Study Completion
April 1, 2023
Last Updated
May 1, 2023
Record last verified: 2023-04