ClinicalTrials.gov record NCT07488728
Letermovir Prophylaxis in Children With EBV-Positive T/NK-Cell Lymphoproliferative Disease and Refractory/Relapsed EBV-Associated Hemophagocytic Lymphohistiocytosis
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
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This interventional prevention study evaluates daily oral letermovir given after allogeneic hematopoietic stem cell transplant in children with EBV-related T/NK-cell lymphoproliferative disease or refractory/relapsed EBV-associated hemophagocytic lymphohistiocytosis. It compares infection rates and transplant complications with a historical control group.
What it is studying. The study is measuring whether giving letermovir after transplant changes the incidence of clinically significant CMV and EBV infections, and it also tracks other viral infections (for example BKV, HHV-6/7, RSV, ADV, HSV), graft-versus-host disease, post-transplant lymphoproliferative disorder, thrombotic microangiopathy, graft failure, relapse, overall survival, and immune reconstitution.
What the researchers hope to learn. To determine the incidence of clinically significant CMV and EBV infections after transplant with or without letermovir prophylaxis; to describe rates of other viral infections and transplant-related complications; and to characterize immune reconstitution and overall survival measures.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- Letermovir
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants who receive letermovir will take the oral drug once daily starting at transplant (day 0) through day 100, with possible extension to day 200 if high‑risk features persist; dosing is weight‑based and may be adjusted if co‑administered with cyclosporine. They will attend regular clinic visits for blood tests to monitor CMV, EBV and other viruses, immune cell counts and function, and to track transplant complications (for example GvHD, graft failure, TMA), with follow‑up visits extending to about one year after transplant. The study uses a historical control group for comparison, so current participants primarily have medication and monitoring rather than additional experimental procedures. No routine invasive procedures beyond standard post‑transplant care are specified in the registry record.
How the study is structured. Interventional, non-randomized, parallel study with no masking. One group of pediatric patients receives daily oral letermovir starting at transplant (typically day 0) through day 100, with possible extension to day 200 for ongoing high-risk factors; a historical control group (2018–2023) received no routine CMV prophylaxis and used preemptive antiviral therapy when PCR thresholds were met.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on hemophagocytic lymphohistiocytosis
Important dates
- Study start
- Oct 1, 2025
- Primary completion
- Dec 31, 2026 (estimated)
- Study completion
- Dec 31, 2026 (estimated)
- Target enrollment
- 80 participants (estimated)
- Last updated on registry
- Mar 23, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Beijing Children's Hospital
- Principal investigator
- Jun Yang, Beijing Children's Hospital
Beijing Children's Hospital
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Jun Yang, Doctor 📞 +86 13699293825 ✉ yangjundabby@outlook.com
Participating sites (1)
- Beijing Children's Hospital, Capital Medical UniversityRecruiting
Beijing, Beijing Municipality, 100032 · China
- Jun Yang · +86 13699293825 · yangjundabby@outlook.com
Terms used on this page · explanations by MedicalUpdates.ai
- refractory
- A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
- relapsed
- A condition that improved with treatment and has since returned or worsened.
- overall survival
- The length of time from the start of the study or treatment that participants are alive, whatever the cause of death.
- allo-HSCT
- A procedure that replaces blood-forming cells after high-dose treatment. 'Autologous' uses the person's own cells collected beforehand; 'allogeneic' uses cells from a donor.
- corticosteroid
- Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- creatinine clearance
- A measure of kidney function, calculated from a blood creatinine level together with age, weight and sex.
- informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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