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New hope for kids: drug may shield against dangerous viruses after transplant

NCT ID NCT07488728

Disease control Sponsor: Beijing Children's Hospital Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests whether the drug letermovir can prevent serious viral infections in children with EBV-related blood disorders who receive a stem cell transplant. About 80 children will be enrolled, and researchers will monitor for infections and other transplant complications. The goal is to improve recovery and survival by reducing viral threats.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

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

Started

Oct 2025

Expected to finish

Dec 2026

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

Up to 18 years

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: * Diagnosed with EBV-positive T/NK lymphoproliferative disease (EBV-T/NK LPD) according to ICC 2022 criteria, or diagnosed with refractory/relapsed EBV-associated hemophagocytic lymphohistiocytosis (EBV-HLH) according to the 2004-HLH diagnostic criteria; * Undergoing first allogeneic hematopoietic stem cell transplantation (allo-HSCT) at the study center; * Age \< 18 years; * CMV seropositive (IgG+) prior to transplantation; * Presence of at least one high-risk factor for CMV infection: haploidentical transplantation, HLA-mismatched transplantation, receipt of ATG (including ATLG/ALG) in conditioning, sustained corticosteroid use post-conditioning, donor/recipient CMV serostatus mismatch, or positive NGS result pre-transplant. Exclusion Criteria: * History of CMV end-organ disease within 6 months prior to enrollment; * Severe hepatic dysfunction (defined as Child-Pugh Class C); * End-stage renal impairment with creatinine clearance \< 10 mL/min (calculated by Cockcroft-Gault equation); * Prior allogeneic hematopoietic stem cell transplantation; * Expected survival ≤ 3 months; * Received radiation therapy during conditioning; * Initiation of letermovir prophylaxis after day 28 post-transplant; * Letermovir dosage or administration not in accordance with the prescribing information; * Lack of signed informed consent.

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Conditions

The condition(s) this trial relates to.

EBV-positive T-cell lymphoproliferative disorder of childhood Epstein-Barr virus-associated lymphoproliferative disorder secondary hemophagocytic lymphohistiocytosis

As listed by the trial registrant

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

EBV-associated T/NK-cell lymphoproliferative diseases Letermovir Refractory/relapsed EBV-related hemophagocytic lymphohistiocytosis

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

  • Beijing Children's Hospital, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 100032, China