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

RecruitingNAAges any - 18 YearsAllBeijing Children's Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค 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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What it tests

  • Letermovir
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Where

1 site
Beijing Children's Hospital, Capital Medical University
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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