Minimal Residual Disease Quantification by Next-generatio... | NCT05837689

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

NCT05837689

Sponsor

Xiaojun Xu

Status

Unknown status

Last Update Posted

May 1, 2023Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Acute Lymphoblastic Leukemia, Pediatric

Interventions

Blinatumomab

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2023Estimated

Primary Completion Date

Apr 2023Estimated

Completion Date

Apr 2023Estimated

First Submitted Date

Mar 31, 2023

First Submission Date that Met QC Criteria

Apr 19, 2023

First Posted Date

May 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2023

Last Update Posted Date

May 1, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiaojun Xu, Principal investigator, The Children's Hospital of Zhejiang University School of MedicineSponsor-Investigator

Lead Sponsor

Xiaojun XuOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Name	Type	Description	Arm Group Labels	Other Names
Blinatumomab	Drug	IV

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma

Ancestor Terms

ID	Term
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C510808	blinatumomab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided