NCT07029958招募中4 期
Improved Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation Protocol for the Treatment of Epstein Barr Virus T/NK Lymphoproliferative Disease (EBV-T/NK LPD) and Prevention of Post Transplant Graft-versus-host Disease
Beijing Children's Hospital1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年11月12日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Incidence of aGVHD
研究概览
简要总结
To investigate whether the addition of recombinant humanized anti-CD25 monoclonal antibody to the conventional EBV-T/NK LPD conditioning regimen can prevent acute and chronic GVHD after transplantation, improve the severity of GVHD and have a corresponding impact on other related post-transplant complications such as poor engraftment, thrombotic microvascular disease, early EBV reactivation and relapse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnosis of EBV-T/NK lymphoproliferative disease (EBV-T/NK LPD) according to the ICC2022 diagnostic criteria
- •Plan to undergo allogeneic hematopoietic stem cell transplantation (allo HSCT) in our hospital
- •Age ≤ 18 years old
- •Sign informed consent form
- •Meet one of the following conditions (haploid donors must meet one of the above conditions, unrelated donors must meet two of the above conditions): ① donor age≥40 years old; ② The donor source is unrelated donor or haplotype related female or collateral donor (brother sisters, etc.) with ≥ 1 point mismatch; ③ CD3≥4 x 10 ^ 8/kg before transplantation; ④ The primary disease is in an HLH (hemophagocytic lymphohistiocytosis) flare or active disease phase; ⑤ ATG (or ATLG (1:2)/ALG (1:20) equivalent dose)<10mg/kg
排除标准
- •The expected survival period for multiple organ failure is no more than 3 months
- •Not signing the informed consent form
研究组 & 干预措施
treatment group
Experimental
干预措施: recombinant humanized anti-CD25 monoclonal antibody (Drug)
结局指标
主要结局
Incidence of aGVHD
时间窗: post-HSCT 100days
次要结局
- Incidence of TMA(post-HSCT 1year)
- Incidence of VOD(post-HSCT 1year)
- Overall survival(post-HSCT 1year)
- Incidence of adverse events(30 days after discontinuation of medication)
研究者
Jun Yang
Doctor
Beijing Children's Hospital
研究点 (1)
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