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

NCT ID: NCT05837689

Last Updated: 2023-05-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-30
• Study Completion Date: 2023-04-30

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.

Conditions

Acute Lymphoblastic Leukemia, Pediatric

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Interventions

Blinatumomab

IV

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiaojun Xu

OTHER

Sponsor Role: lead

Responsible Party

Xiaojun Xu

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

2023-IRB-0062-P-01

Identifier Type: -

Identifier Source: org_study_id