Letermovir prophylaxis to prevent viral infections after transplant in children with EBV-positive T/NK-cell disease or relapsed EBV-HLH
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
Run by Beijing Children's Hospital · NCT07488728 · Data updated 2026-11-12
This trial tests whether giving letermovir after allogeneic stem cell transplant can prevent viral infections in children under 18 with EBV-positive T/NK-cell lymphoproliferative disease or refractory/relapsed EBV-related hemophagocytic lymphohistiocytosis who are CMV IgG positive and at high risk for CMV.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 18 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Beijing Children's Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | March 23, 2026 |
| Trial ID | NCT07488728 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children younger than 18 undergoing their first allogeneic HSCT for EBV-positive T/NK-cell LPD or refractory/relapsed EBV-HLH who are CMV IgG positive and have at least one high-risk factor for CMV are ideal candidates.
✕Probably not a fit
Patients with recent CMV end-organ disease, severe hepatic failure (Child-Pugh C), end-stage renal impairment, those who are CMV seronegative, or those not undergoing allo-HSCT are unlikely to receive benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study gives letermovir as prophylaxis to pediatric patients undergoing their first allogeneic hematopoietic stem cell transplant for EBV-positive T/NK-cell lymphoproliferative disease or refractory/relapsed EBV-associated HLH. Eligible children are under 18, CMV IgG positive before transplant, and have at least one predefined high-risk feature for CMV reactivation. Participants receive letermovir during the transplant period and are followed for viral infections (including CMV, EBV, BKV, HHV-6/7, RSV, ADV, HSV) as well as transplant complications such as engraftment failure, graft-versus-host disease, relapse, thrombotic microangiopathy, post-transplant lymphoproliferative disorder, immune reconstitution, and overall survival. Outcomes and safety events are recorded at the study center and analyzed to determine the effect of letermovir prophylaxis on post-transplant viral and clinical outcomes.
Why it matters
Potential benefit: If successful, letermovir prophylaxis could reduce post-transplant viral reactivations and related complications, potentially improving survival and recovery after allo-HSCT in these high-risk children.
How similar studies have gone: Letermovir has demonstrated success preventing CMV reactivation and disease in adult HSCT recipients, but its use specifically in pediatric EBV-associated T/NK LPD and EBV-HLH populations is novel and less well studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Jun Yang, Doctor
- Email: yangjundabby@outlook.com
- Phone: +86 13699293825
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.