Minimal Residual Disease Quantification by Next-generation Sequencing in Pediatric B-ALL Children Patients Treated With Blinatumomab Consolidation
Sponsor
Xiaojun Xu (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05837689
Collaborator
(none)
20
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
20 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Minimal Residual Disease Quantification by Next-generation Sequencing in Pediatric B-ALL Children Patients Treated With Blinatumomab Consolidation
Anticipated Study Start Date
:
Apr 1, 2023
Anticipated Primary Completion Date
:
Apr 1, 2023
Anticipated Study Completion Date
:
Apr 1, 2023
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Ages Eligible for Study:
1 Year
to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Xiaojun Xu
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Xiaojun Xu,
Principal investigator,
The Children's Hospital of Zhejiang University School of Medicine
ClinicalTrials.gov Identifier:
NCT05837689
Other Study ID Numbers:
- 2023-IRB-0062-P-01
First Posted:
May 1, 2023
Last Update Posted:
May 1, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: