The Molecular Mechanism of CMV-driven NKG2C+NK Cell Expan... | NCT04298502

Studies
The Molecular Mechanism of CMV-driven NKG2C+NK Cell Expansion in Human

NCT04298502

Sponsor

Peking University People's Hospital

Status

Unknown status

Last Update Posted

Oct 1, 2020Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Acute Leukemia
CMV Viremia
Hematopoietic Stem Cell Transplantation

Interventions

Not provided

Countries

China

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

Sep 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Mar 4, 2020

First Submission Date that Met QC Criteria

Mar 4, 2020

First Posted Date

Mar 6, 2020Actual

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

Sep 30, 2020

Last Update Posted Date

Oct 1, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiaojun Huang,MD, Head of Peking University Institute of Hematology, Peking University People's HospitalPrincipal Investigator

Lead Sponsor

Peking University People's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

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

This is an observation study to investigate the molecular mechanism of NKG2C+NK cell expansion after HCMV infection

Detailed Description

According to the changes of molecular and gene expression in NK cells at different time points after infection, we want to find out the mechanism by which HCMV promotes the expansion of NKG2C + NK cells.

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

Retention

Enrollment

40Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CMV viremia	CMV-DNA>1.0x10^3 cpies/mL	2 moths post-transplantation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

AML or MDS or CML or ALL undergoing haploidentical stem cells transplantation
No severe organ dysfunction or failure
Subjects must be capable of, and willing to provide written informed consent to participate in the study. Subjects unable to provide written informed consent by themselves may be consented through their legal representative.

Exclusion Criteria:

Participation in another industry-sponsored clinical study where treatment for CMV is already specified by the study protocol.
Patients received other adoptive immunotherapy such as donor lymphocyte infusion (DLI), Epstein-Barr virus (EBV)-specific T cells and so on.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

AML or MDS or CML or ALL undergoing haploidentical stem cells transplantation AND the healthy donors.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiangyu Zhao, M.D., PhD	Contact	+8610-88325949		xyz80421@126.com

Overall Officials

Name	Affiliation	Role
Xiaojun Huang, M.D., PhD	Peking University People's Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Institute of Hematology	Recruiting	Beijing	Beijing Municipality	100044	China