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New blood tests could sharpen CMV monitoring in transplant patients

NCT ID NCT07286461

Knowledge-focused Sponsor: University of Rome Tor Vergata Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether measuring two new viral markers (CMV-RNA and TTV-DNA) in the blood can give a clearer picture of CMV infection in patients who have had a stem cell transplant and are taking the drug letermovir to prevent CMV. Researchers will track 290 adult transplant recipients to see if these markers predict when CMV reactivates or when anti-CMV treatment is needed. The goal is to improve monitoring and reduce unnecessary treatments.

What this could mean

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

Active substance
letermovir prophylaxis
What this could lead to
If successful, this could lead to more accurate monitoring of CMV infection in transplant patients, potentially reducing unnecessary treatments and improving outcomes.
What could go wrong
This is an observational study, not a treatment trial. The markers being tested may not prove reliable enough to change current practice. Results are exploratory and need further validation.

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.

Participants

About 290 people

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

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Dec 2027

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.

Who is studied

This observational study will include at least 290 consecutive patients undergoing HSCT at risk of CMV infection. Clinical management of participants will be carried out according to international and local guidelines, without any modification due to the current study. Participants will be followed for the entire duration of prophylaxis treatment followed by a minimum of 3 months after suspension.

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: * Be \> 18 years of age * Sign an informed consent * HSCT recipients seropositive to CMV, or receiving HSCs from a CMV seropositive donor * Antiviral prophylaxis with letermovir for preventing CMV infection will be administered for 100 days in Italy (or 200 days in Germany) after HSCT to all participants according to the current guidelines Exclusion Criteria: Individuals \<18 years old undergoing HSCT Individuals not receiving letermovir prophylaxis

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Conditions

The condition(s) this trial relates to.

cytomegalovirus infection

As listed by the trial registrant

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

Allogeneic hematopoietic stem cell transplantation recipient CMV

How to take part

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

  1. The places running it

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

  2. 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 ↗

  3. 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

Locations

  • Heinrich-Heine-Universitaet Duesseldorf

    Düsseldorf, Germany

More trials for these conditions

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