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RECRUITING
NCT06453460
PHASE2

CMV-TCIP Directed Letermovir Prophylaxis After Allo-SCT

Sponsor: University of California, Irvine

View on ClinicalTrials.gov

Summary

This is a phase 2, prospective cohort clinical trial evaluating the utilization of CMV T Cell Immunity Panel (CMV-TCIP) assay to guide the duration of primary CMV prophylaxis in CMV-seropositive recipients of allogeneic stem cell transplant or recipients receiving a stem cell graft from a CMV serology positive donor.

Official title: Prospective Evaluation of Efficacy of CMV-specific T Cell Immunity (CMV-TCIP) Directed Letermovir Prophylaxis After Allogeneic Hematopoietic Cell Transplantation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-06-27

Completion Date

2029-06

Last Updated

2025-07-09

Healthy Volunteers

No

Interventions

DRUG

Letermovir

Subjects will receive 14 weeks of letermovir prophylaxis at standard recommended dose follow by CMV-TCIP-directed extended prophylaxis.

DEVICE

CMV T Cell Immunity Panel (CMV-TCIP)

Viracor CMV-TCIP assay to measure how a person's immune system responds to CMV. Viracor CMV-TCIP will be measured monthly, starting at week 14, until positive, then at week 30 and 52.

DIAGNOSTIC_TEST

CMV DNA PCR

Plasma level of CMV DNA PCR will be measured at enrollment and at least weekly through week 30, then at least every 2 weeks through week 52 of transplant if no GVHD or CMV reactivation.

Locations (1)

Chao Family Comprehensive Cancer Center, University of California Irvine

Orange, California, United States