RecruitingPhase 2NCT06453460

CMV-TCIP Directed Letermovir Prophylaxis After Allo-SCT

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

Sponsor

University of California, Irvine

Enrollment

50 participants

Start Date

Jun 27, 2024

Study Type

INTERVENTIONAL

Conditions

allogeneic stem cell transplantation CMV

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying CMV DNA PCR, a medical device called CMV T Cell Immunity Panel (CMV-TCIP), and others for people with cmv and allogeneic stem cell transplantation. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLetermovir

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

DEVICECMV 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_TESTCMV 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

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NCT06453460

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