RecruitingNot ApplicableNCT07488728

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

Sponsor

Beijing Children's Hospital

Enrollment

80 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

EBV-associated T/NK-cell Lymphoproliferative Diseases Refractory/Relapsed EBV-related Hemophagocytic Lymphohistiocytosis Letermovir

Summary

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.

Eligibility

Max Age: 18 Years

Inclusion Criteria5

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 Criteria9

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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Interventions

DRUGLetermovir

Arm 1 (Letermovir Prophylaxis): Pediatric patients receive oral letermovir once daily from day 0 to day 100 post-transplant. Prophylaxis may be extended to day 200 if high-risk factors persist (steroid use, poor immune reconstitution). Dosing: 480mg (≥30kg), 240mg (15-30kg), 120mg (7.5-15kg), 80mg (6-7.5kg); halved if co-administered with cyclosporine. Arm 2 (Control): Historical control cohort (2018-2023) receiving no routine CMV prophylaxis; preemptive therapy with ganciclovir/foscarnet initiated only when plasma PCR exceeds threshold.

Locations(1)

Beijing Children's Hospital, Capital Medical University

Beijing, Beijing Municipality, China

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NCT07488728