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Letermovir after stem cell transplant in children with EBV blood diseases

Tests letermovir against viruses in transplanted children with EBV diseases.

Key facts

Who runs it
Beijing Children's Hospital
Where
China1 site in 1 countryChoose a country to see its sites
Trial code
Registry title
Letermovir Prophylaxis in Children With EBV-Positive T/NK-Cell Lymphoproliferative Disease and Refractory/Relapsed EBV-Associated Hemophagocytic Lymphohistiocytosis
Status
Recruiting
People taking part
80 people, planned
Started
1 Oct 2025
Expected to end
31 Dec 2026
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Letermovir
Record updated
23 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children under 18 with EBV-positive T/NK lymphoproliferative disease or refractory/relapsed EBV-associated HLH. They must be having their first donor stem cell transplant at the study center. The trial looks at letermovir given to prevent virus infections after the transplant.

Age
Under 18 years
Sex
All sexes
Disease stage
EBV-positive T/NK lymphoproliferative disease (ICC 2022 criteria), or EBV-associated hemophagocytic lymphohistiocytosis (HLH) that did not respond to treatment or came back (2004-HLH criteria). Children must be having their first allogeneic (donor) stem cell transplant. They must have at least one high-risk factor for CMV infection. Examples: a half-compatible (haploidentical) donor, a donor with a different HLA tissue type, ATG (including ATLG/ALG) before the transplant, or ongoing steroids after conditioning. Other examples: a donor and recipient with different CMV antibody results, or a positive NGS test before the transplant.
Earlier treatment
No earlier donor stem cell transplant. No radiation therapy as part of conditioning, the treatment given before the transplant. Letermovir must start no later than day 28 after the transplant. It must be given as the prescribing information says.
Biomarker or test result
Positive CMV antibody test (IgG+) before the transplant.

Main reasons for not taking part

  • CMV disease affecting an organ in the 6 months before joining
  • Severe liver problems (Child-Pugh Class C)
  • End-stage kidney problems with creatinine clearance < 10 mL/min
  • Expected survival of 3 months or less
  • Earlier donor stem cell transplant

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • History of CMV end-organ disease within 6 months prior to enrollment
  • Prior allogeneic hematopoietic stem cell transplantation
  • Received radiation therapy during conditioning
  • Initiation of letermovir prophylaxis after day 28 post-transplant
  • End-stage renal impairment with creatinine clearance < 10 mL/min (calculated by Cockcroft-Gault equation)
  • Severe hepatic dysfunction (defined as Child-Pugh Class C)
  • Expected survival ≤ 3 months
  • Letermovir dosage or administration not in accordance with the prescribing information
  • Lack of signed informed consent

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

This study investigates the impact of letermovir prophylaxis on viral infections (including CMV, EBV, BKV, HHV-6/7, RSV, ADV, HSV, etc.) following allogeneic hematopoietic stem cell transplantation in pediatric patients with EBV-associated T/NK-cell lymphoproliferative diseases and refractory/relapsed EBV-related hemophagocytic lymphohistiocytosis. Additionally, we examine its effects on other transplantation complications, including engraftment failure, graft-versus-host disease (GvHD), disease relapse, thrombotic microangiopathy (TMA), overall survival (OS), post-transplant lymphoproliferative disorder (PTLD) incidence, and immune reconstitution.

The 2 groups in the trial

  • Children with Letermovir for Cytomegalovirus prophylaxis after HSCTTreatment being tested

    Treatment: Letermovir

  • Children with preemptive therapy, without Letermovir for Cytomegalovirus prophylaxis after HSCTNo study treatment, for comparison

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Impact of Letermovir Prophylaxis on Viral Infections After Allogeneic Hematopoietic Stem Cell Transplantation in Children With EBV-Positive T/NK-Cell Lymphoproliferative Disease and Refractory/Relapsed EBV-Associated Hemophagocytic Lymphohistiocytosis
Plain-language title
Letermovir after stem cell transplant in children with EBV blood diseasesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
23 March 2026