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Blood test after transplant may flag hidden virus risk

NCT ID NCT06814301

Knowledge-focused Sponsor: Maimónides Biomedical Research Institute of Córdoba Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 123 stem cell transplant patients to see if measuring their immune response to CMV after stopping a preventive drug (letermovir) can predict late infections. Participants will have regular blood tests up to 200 days after transplant. The goal is to learn whether a weak immune response signals higher risk, which could help tailor future prevention.

What this could mean

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

What this could lead to
If successful, this could help doctors personalize how long CMV prevention is needed after a stem cell transplant, reducing late infections.
What could go wrong
This is an observational study, not a treatment trial. It may not prove that immune monitoring directly improves outcomes, and results may not apply to all patients.

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 123 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

Sep 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

Consecutive CMV seropositive patients undergoing allogenic-SCT who receive LTV prophylaxis will be included. These patients will be prospectively evaluated during the first 200 days post-SCT.

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: * Age \>18 years. * CMV seropositivity (positive IgG) in the recipient at the time of SCT. * First allogeneic hematopoietic stem cell transplant recipient (bone marrow, peripheral blood, or cord blood). * Within the first 28 days post-SCT at the time of inclusion. * Indication for LTV prophylaxis within the first 28 days post-transplant up to 100 days post-SCT, according to the criteria established in each center. Exclusion Criteria: * CMV seronegativity (negative IgG) in the recipient at the time of transplant. * Previous allogeneic stem cell transplant (patients with a prior autologous transplant are allowed to be included). * History of CMV disease in the 6 months prior to inclusion. * Need for preemptive therapy in the month prior to inclusion in the study. * Received any of the following in the 14 days prior to inclusion: Ganciclovir, valganciclovir, foscarnet, acyclovir (at doses \>3200 mg orally per day or \>25 mg/kg IV per day), valacyclovir (at doses \>3000 mg orally per day), famciclovir (at doses \>1500 mg orally per day). * Received any of the following in the 30 days prior to screening: Cidofovir, CMV hyperimmune immunoglobulin, any CMV antiviral in the investigational phase. * Suspected or confirmed hypersensitivity reaction to the LTV formulation or any of its components. * Severe hepatic insufficiency (defined as Child-Pugh class C). * History of primary immunodeficiency prior to transplant. * Participation in a clinical trial involving the administration of CMV vaccines, other investigational CMV drugs, or monoclonal antibodies.

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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.

Cytomegalovirus cell mediated immunity Stem cell transplantation, hematopoietic

How to take part

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  1. The places running it

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

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Hospital Universitario Reina Sofía

    Córdoba, Córdoba, 14004, Spain

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