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NCT04298502 Clinical Trial

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

Acute Leukemia Clinical Trial

Official title:
The Molecular Mechanism of CMV-driven NKG2C+NK Cell Expansion in Human

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04298502
Other study ID # HCMV-NKG2C+ NK cell
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date December 31, 2021

Study information
Verified date September 2020
Source Peking University People's Hospital
Contact Xiangyu Zhao, M.D., PhD
Phone +8610-88325949
Email xyz80421@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date December 31, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

1. AML or MDS or CML or ALL undergoing haploidentical stem cells transplantation

2. No severe organ dysfunction or failure

3. 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:

1. Participation in another industry-sponsored clinical study where treatment for CMV is already specified by the study protocol.

2. Patients received other adoptive immunotherapy such as donor lymphocyte infusion (DLI), Epstein-Barr virus (EBV)-specific T cells and so on.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Peking University Institute of Hematology Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary CMV viremia CMV-DNA>1.0x10^3 cpies/mL 2 moths post-transplantation
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