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

• Conditions: Acute Leukemia; CMV Viremia; Hematopoietic Stem Cell Transplantation

• Registration Number: NCT04298502
• Lead Sponsor: Peking University People's Hospital

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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-03-04
• Study First Submitted QC: 2020-03-04
• Study First Posted: 2020-03-06
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-30
• Last Update Posted: 2020-10-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CMV viremia	2 moths post-transplantation	CMV-DNA\>1.0x10\^3 cpies/mL

Trial Locations

Locations (1)

Peking University Institute of Hematology; 🇨🇳 Beijing, Beijing, China