CMV Immunity Monitoring in Lung Transplant Recipients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Lung Transplant Recipients 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. |
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).
Other Names:
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.
Other Names:
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.
|
Outcome Measures
Primary Outcome Measures
- 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
- Incidence of CMV Viremia [Up to Month 12 Post-Transplant]
Number of times CMV DNA is detected in patients' blood.
- 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 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 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 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Received a lung transplant, or multi-organ transplant involving a lung at NYU Langone Health
-
Pre-existing serological immunity to CMV (R+)
-
Able and willing to provide informed consent
Exclusion Criteria:
-
Anti-thymocyte globulin induction immunosuppression
-
Perioperative desensitization
-
Pregnant or breastfeeding women
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NYU Langone Health | New York | New York | United States | 10016 |
Sponsors and Collaborators
- NYU Langone Health
- Viracor Eurofins
Investigators
- Principal Investigator: Luis Angel, MD, NYU Langone Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-01138