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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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Children's Hospital, Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Jun Yang, Doctor
yangjundabby@outlook.com
+86 13699293825
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 80
Treatments
Experimental: Children with Letermovir for Cytomegalovirus prophylaxis after HSCT
No_intervention: Children with preemptive therapy, without Letermovir for Cytomegalovirus prophylaxis after HSCT
Sponsors
Leads: Beijing Children's Hospital

This content was sourced from clinicaltrials.gov