CMV Immunity Monitoring in Lung Transplant Recipients

NYU Langone Health

Status and phase: Enrolling; Phase 2

Conditions: Lung Transplant; Complications

Treatments: Diagnostic Test: Donor-Derived Cell-Free DNA (dd-cfDNA) Assay; Device: Cytomegalovirus T Cell Immunity Panel (CMV-TCIP); Drug: Valganciclovir

Study type: Interventional

Funder types: Other

Identifiers

NCT05708755

22-01138

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Lung Transplant Recipients

Experimental group

Description:

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.

Treatment:

Drug: Valganciclovir

Device: Cytomegalovirus T Cell Immunity Panel (CMV-TCIP)

Diagnostic Test: Donor-Derived Cell-Free DNA (dd-cfDNA) Assay