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Blood test could tailor CMV prevention after stem cell transplants

NCT ID NCT06453460

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether a blood test that measures CMV-specific immunity (CMV-TCIP) can help doctors decide how long to continue the antiviral drug letermovir after an allogeneic stem cell transplant. Participants receive letermovir for 14 weeks, then the test guides whether to extend prophylaxis. The goal is to prevent clinically significant CMV infection within the first year after transplant.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
letermovir, a drug to prevent CMV infection, and a CMV immunity blood test (CMV-TCIP) to guide treatment duration
What this could lead to
If successful, this approach could reduce CMV infections after stem cell transplant while avoiding unnecessary prolonged medication.
What could go wrong
This is a small, early-phase trial, so results may not apply to all patients. The blood test may not accurately predict infection risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * ≥ 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 1. Serum creatinine clearance ≥50 ml/min (calculated with Cockroft-Gault formula). 2. Bilirubin ≤1.5 mg/dl except for Gilbert's disease. 3. ALT or AST ≤200 IU/ml for adults. 4. Conjugated (direct) bilirubin \< 2x upper limit of normal. 5. Left ventricular ejection fraction ≥40%. 6. Diffusing capacity for carbon monoxide (DLCO) ≥ 50% predicted corrected for hemoglobin. Exclusion Criteria: * 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: 1. Ganciclovir 2. Valganciclovir 3. Foscarnet 4. Acyclovir (\> 3200 mg PO per day or \> 25 mg/kg IV per day) 5. Valacyclovir (\> 3000 mg/day) 6. Famciclovir (\> 1500 mg/day) * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Chao Family Comprehensive Cancer Center, University of California Irvine

    RECRUITING

    Orange, California, 92868, United States

    Contact Email: •••••@•••••

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