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

Acute Lymphoblastic Leukemia, Pediatric Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05837689
• Other study ID #: 2023-IRB-0062-P-01
• Status: Not yet recruiting
• Start date: April 2023
• Est. completion date: April 2023

Study information

• Verified date: April 2023
• Source: The Children's Hospital of Zhejiang University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: April 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia, Pediatric
• Neoplasm, Residual
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Blinatumomab
IV

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xiaojun Xu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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