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CMV-TCIP Directed Letermovir Prophylaxis After Allo-SCT

NCT06453460 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-07-09

No results posted yet for this study

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.

Conditions

  • CMV
  • Allogeneic Stem Cell Transplantation

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.

Sponsors & Collaborators

  • Eurofins Viracor

    collaborator UNKNOWN

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Piyanuch Kongtim, MD,PhD · Chao Family Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-27
Primary Completion
2028-06-30
Completion
2029-06-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06453460 on ClinicalTrials.gov