CMV Immunity Monitoring in Lung Transplant Recipients

Phase 2

Not yet recruiting

• Conditions: Lung Transplant; Complications
• Interventions: Device: Cytomegalovirus T Cell Immunity Panel (CMV-TCIP); Diagnostic Test: Donor-Derived Cell-Free DNA (dd-cfDNA) Assay; Drug: Valganciclovir

• Registration Number: NCT05708755
• Lead Sponsor: NYU Langone Health

Brief Summary

The purpose of this study is to determine the safety and feasibility of using a laboratory test to guide duration of antiviral prophylaxis with valganciclovir (medication used to prevent viral infections) after lung transplant. The laboratory test, inSIGHT™ CMV T Cell Immunity Panel, measures patients' immune response to a common viral infection known as cytomegalovirus (CMV). The goal of this study will be to safely decrease how long patients need to take valganciclovir based on the results of the CMV T Cell Immunity Panel.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-24
• Study First Submitted QC: 2023-01-24
• Study First Posted: 2023-02-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-14
• Study Start: 2024-04
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Received a lung transplant, or multi-organ transplant involving a lung at NYU Langone Health
2. Pre-existing serological immunity to CMV (R+)
3. Able and willing to provide informed consent

Exclusion Criteria

1. Anti-thymocyte globulin induction immunosuppression
2. Perioperative desensitization
3. Pregnant or breastfeeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lung Transplant Recipients	Cytomegalovirus T Cell Immunity Panel (CMV-TCIP)	Lung transplant recipients with pre-transplant serological immunity to CMV. CMV-TCIP will be measured every 3 months post-transplant with antiviral prophylaxis discontinued when threshold is exceeded.
Lung Transplant Recipients	Donor-Derived Cell-Free DNA (dd-cfDNA) Assay	Lung transplant recipients with pre-transplant serological immunity to CMV. CMV-TCIP will be measured every 3 months post-transplant with antiviral prophylaxis discontinued when threshold is exceeded.
Lung Transplant Recipients	Valganciclovir	Lung transplant recipients with pre-transplant serological immunity to CMV. CMV-TCIP will be measured every 3 months post-transplant with antiviral prophylaxis discontinued when threshold is exceeded.

Primary Outcome Measures

Name	Time	Method
CMV Viremia-Free Survival	Up to Month 12 Post-Transplant	Defined as the the time from lung transplant until the first detection of CMV DNA in patients' blood.

Secondary Outcome Measures

Name	Time	Method
Incidence of CMV Viremia Requiring Treatment	Up to Month 12 Post-Transplant	Number of times treatment is necessary after CMV DNA is detected in patients' blood.
Incidence of Bacterial Pneumonia	Up to Month 12 Post-Transplant	Measure of non-CMV post-transplant infectious complications.
Incidence of Aspergillus Infection	Up to Month 12 Post-Transplant	Measure of non-CMV post-transplant infectious complications.
Incidence of CMV Viremia	Up to Month 12 Post-Transplant	Number of times CMV DNA is detected in patients' blood.
Incidence of Treatment-Resistant CMV Viremia	Up to Month 12 Post-Transplant	Number of times treatment for CMV Viremia does not appear effective after CMV DNA is detected in patients' blood.
Incidence of Varicella Zoster Reactivation	Up to Month 12 Post-Transplant	Measure of non-CMV post-transplant infectious complications.
Incidence of Neutropenia	Up to Month 12 Post-Transplant

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States