CMV Immunity Monitoring in Lung Transplant Recipients

Lung Transplant; Complications Clinical Trial

Official title:

Cytomegalovirus T Cell Immunity and Antiviral Prophylaxis Minimization in Lung Transplant Recipients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05708755
• Other study ID #: 22-01138
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 2024
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: NYU Langone Health
• Contact: Tyler Lewis
• Phone: 866-838-5864
• Email: Tyler.lewis[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Transplant; Complications

Intervention

Device:
• Cytomegalovirus T Cell Immunity Panel (CMV-TCIP)
Whole blood assay that evaluates T cell (CD4 and CD8) responses to cytomegalovirus (CMV) antigens via intracellular cytokine staining (ICS).

Diagnostic Test:
• Donor-Derived Cell-Free DNA (dd-cfDNA) Assay
Determines the percentage of circulating cell-free DNA (cfDNA) in transplant recipients derived from donor grafts.

Drug:
• Valganciclovir
Delivered as standard of care for post-lung transplant immunosuppression and infection prophylaxis. Started on the first day post-transplant at a standard dose of 900 mg daily and continued for 12 months. Dose adjustments may be necessary based on renal function and/or adverse effects (e.g. neutropenia). Dose adjustments are standard based on package insert recommendations.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	Viracor Eurofins

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CMV Viremia-Free Survival	Defined as the the time from lung transplant until the first detection of CMV DNA in patients' blood.	Up to Month 12 Post-Transplant
Secondary	Incidence of CMV Viremia	Number of times CMV DNA is detected in patients' blood.	Up to Month 12 Post-Transplant
Secondary	Incidence of CMV Viremia Requiring Treatment	Number of times treatment is necessary after CMV DNA is detected in patients' blood.	Up to Month 12 Post-Transplant
Secondary	Incidence of Treatment-Resistant CMV Viremia	Number of times treatment for CMV Viremia does not appear effective after CMV DNA is detected in patients' blood.	Up to Month 12 Post-Transplant
Secondary	Incidence of Bacterial Pneumonia	Measure of non-CMV post-transplant infectious complications.	Up to Month 12 Post-Transplant
Secondary	Incidence of Aspergillus Infection	Measure of non-CMV post-transplant infectious complications.	Up to Month 12 Post-Transplant
Secondary	Incidence of Varicella Zoster Reactivation	Measure of non-CMV post-transplant infectious complications.	Up to Month 12 Post-Transplant
Secondary	Incidence of Neutropenia		Up to Month 12 Post-Transplant