NCT04298502

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

October 1, 2020

Status Verified

September 1, 2020

Enrollment Period

1 year

First QC Date

March 4, 2020

Last Update Submit

September 30, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • CMV viremia

    CMV-DNA\>1.0x10\^3 cpies/mL

    2 moths post-transplantation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Institute of Hematology

Beijing, Beijing Municipality, 100044, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood

Study Officials

  • Xiaojun Huang, M.D., PhD

    Peking University People's Hospital

    STUDY CHAIR

Central Study Contacts

Xiangyu Zhao, M.D., PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Peking University Institute of Hematology

Study Record Dates

First Submitted

March 4, 2020

First Posted

March 6, 2020

Study Start

January 1, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2021

Last Updated

October 1, 2020

Record last verified: 2020-09

Locations