Actively Recruiting
Letermovir Prophylaxis in Children With EBV-Positive T/NK-Cell Lymphoproliferative Disease and Refractory/Relapsed EBV-Associated Hemophagocytic Lymphohistiocytosis
Led by Beijing Children's Hospital · Updated on 2026-03-23
80
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Letermovir Prophylaxis in Children With EBV-Positive T/NK-Cell Lymphoproliferative Disease and Refractory/Relapsed EBV-Associated Hemophagocytic Lymphohistiocytosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with EBV-positive T/NK-cell lymphoproliferative disease or refractory/relapsed EBV-associated hemophagocytic lymphohistiocytosis
- Undergoing first allogeneic hematopoietic stem cell transplantation at the study center
- Younger than 18 years
- CMV seropositive (IgG positive) before transplantation
- Has at least one high-risk factor for CMV infection such as haploidentical transplant, HLA mismatch, use of ATG in conditioning, ongoing corticosteroid use post-conditioning, donor/recipient CMV mismatch, or positive NGS result pre-transplant
You will not qualify if you...
- History of CMV end-organ disease within 6 months prior to enrollment
- Severe liver dysfunction (Child-Pugh Class C)
- End-stage kidney failure with creatinine clearance less than 10 mL/min
- Previous allogeneic hematopoietic stem cell transplantation
- Expected survival of 3 months or less
- Radiation therapy during conditioning
- Starting letermovir prophylaxis after day 28 post-transplant
- Letermovir dose or administration not following prescribing information
- No signed informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100032
Actively Recruiting
Research Team
J
Jun Yang, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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