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CMV-TCIP Directed Letermovir Prophylaxis After Allogeneic Stem Cell Transplant

This study is for people aged 18 or older who have had an allogeneic stem cell transplant (a transplant using stem cells from a donor) and are at risk for cytomegalovirus (CMV) infection. CMV is a common virus that can cause problems after a transplant. The study is testing if using a special blood test called the CMV T Cell Immunity Panel (CMV-TCIP) can help doctors decide how long to give a medicine called Letermovir. Letermovir is used to prevent CMV infection. You would receive Letermovir for 14 weeks, and then the CMV-TCIP test would help guide further treatment. Researchers will measure how many participants get a significant CMV infection within 52 weeks after their transplant. This study is currently recruiting about 50 participants.

Study design
This is a Phase 2 interventional study, meaning it tests a specific treatment approach. It will involve about 50 participants.
What's involved
You would receive Letermovir for 14 weeks. You would also have monthly blood tests (CMV-TCIP) starting at week 14, and other blood tests (CMV DNA PCR) weekly or every two weeks for up to 52 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 52 weeks after transplant, indicating follow-up for at least one year.

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NCT06453460

CMV-TCIP Directed Letermovir Prophylaxis After Allo-SCT

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of California, Irvine
~50 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:LetermovirCMV T Cell Immunity Panel (CMV-TCIP)CMV DNA PCR

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cumulative incidence of clinically significant cytomegalovirus infection (CS-CMVi) at 52 weeks after transplant
Measured over 1 year after transplant

Conditions

CMV
Allogeneic Stem Cell Transplantation

Explore related trials

Allogeneic Stem Cell TransplantationCytomegalovirus

Where it's being run

1 sites across 1 states
California1

Study leadership

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

Who to contact

Chao Family Comprehensive Cancer Center University of California, Irvine
[email protected]
1-877-827-8839
Email the study team

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Eligibility criteria

Inclusion

≥ 18 years of age on the day of signing informed consent.
Karnofsky performance \>70%
Have documented seropositivity for CMV (either donor or recipient CMV IgG seropositivity) before AHCT.
Eligible for AHCT from an HLA-matched related, matched unrelated, mismatched unrelated or haploidentical donor using either bone marrow or peripheral blood stem cells.
Have undetectable CMV DNA from a plasma sample collected within 5 days prior to enrollment.
Must be within Day-10 thru Day+28 days of planned HSCT at the time of enrollment.
Be able to comply with medical recommendations or follow-up.
Has adequate organ functions determined by

Exclusion

Has a history of CMV end-organ disease or CS-CMVi within 6 months prior to enrollment.
Received within 7 days prior to screening or plans to receive during the study any of the following:
Received within 30 days prior to screening or plans to receive during the study any of the following drugs: cidofovir, CMV hyper-immune globulin, any investigational CMV antiviral agent/biologic therapy.
Has suspected or known hypersensitivity to active or inactive ingredients of letermovir formulations.
Has an uncontrolled infection
Requires mechanical ventilation or is hemodynamically unstable

What this trial measures

  • Cumulative incidence of clinically significant cytomegalovirus infection (CS-CMVi) at 52 weeks after transplant1 year after transplant

    Number of patients who develop CS-CMVi within 52 weeks after receiving a transplant