Letermovir Prophylaxis in Children With EBV-Positive T/NK-Cell Lymphoproliferative Disease and Re⦠(NCT07488728) | Clinical Trial Compass
RecruitingNot Applicable
Letermovir Prophylaxis in Children With EBV-Positive T/NK-Cell Lymphoproliferative Disease and Refractory/Relapsed EBV-Associated Hemophagocytic Lymphohistiocytosis
China80 participantsStarted 2025-10-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Incidence of Clinically Significant CMV Infection (cs-CMVi) and EBV Infection (cs-EBVi)
Timeframe: Up to 180 days and 360 days post-transplant