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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence of Clinically Significant CMV Infection (cs-CMVi) and EBV Infection (cs-EBVi)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Incidence of Clinically Significant CMV Infection (cs-CMVi) and EBV Infection (cs-EBVi)
时间窗: Up to 180 days and 360 days post-transplant
To evaluate the incidence of clinically significant CMV and EBV infections in pediatric patients after allogeneic hematopoietic stem cell transplantation (allo-HSCT) with or without letermovir prophylaxis.
次要结局
- Incidence of Other Viral Infections and Transplant-Related Complications(Up to 100, 180, 270, and 360 days post-transplant)
研究者
Jun Yang
Beijing Children's Hospital
Beijing Children's Hospital