Letermovir prophylaxis to prevent viral infections after transplant in children with EBV-positive T/NK-cell disease or relapsed EBV-HLH
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Beijing Children's Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07488728 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.