Letermovir Prophylaxis in Children With EBV-Positive T/NK-Cell Lymphoproliferative Disease and Refractory/Relapsed EBV-Associated Hemophagocytic Lymphohistiocytosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorBeijing Children's Hospital

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Letermovir

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators