NCT05532826招募中不适用
Clinical Study on the Efficacy and Safety of Donor EBV-CTL Infusion in Patients With CAEBV and EBV-associated Hemophagocytic Lymphohistiocytosis After Allogeneic Hematopoietic Stem Cell Transplantation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- EBV-DNA
研究概览
简要总结
To evaluate the efficacy and safety of donor EBV-specific T lymphocytes (EBV-CTL) infusion in patients with chronic active Epstein-Barr virus infection (CAEBV) and EBV-associated hemophagocytic lymphohistiocytosis (EBV-HLH) after allogeneic hematopoietic stem cell transplantation (allo-HSCT)
详细描述
Evaluate the efficacy and safety of donor EBV-specific T lymphocytes (EBV-CTL) infusion in patients with chronic active Epstein-Barr virus infection (CAEBV) and EBV-associated hemophagocytic lymphohistiocytosis (EBV-HLH) after allogeneic hematopoietic stem cell transplantation (allo-HSCT)
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
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CAEBV or EBV-HLH who were eligible for allogeneic hematopoietic stem cell transplantation agreed to regular monitoring of EBV-DNA after transplantation.
- •Age ≤65 years old, ECOG score 0-
- •Organ function: Cardiac EF≥40%, creatinine clearance ≥50%, aminotransferase (ALT/AST) < 200U/L.
- •The estimated survival time is more than 3 months. 5) Have donors who meet the requirements of allogeneic hematopoietic stem cell transplantation donors， and the donor agreed to collect lymphocytes to prepare EBV-CTL
排除标准
- •The patient or donor had a New York Heart Association (NYHA) score of grade II or higher (including grade II). Or a definite diagnosis of cirrhosis.
- •There are active infections other than EBV that have not yet been controlled.
- •The donor has a blood-borne infectious disease (e.g. HIV, hepatitis B, hepatitis C, syphilis, etc.). The patient was positive for HBV-DNA or HCV-RNA.
- •Active major hemorrhage of internal organs (including gastrointestinal hemorrhage, alveolar hemorrhage, intracranial hemorrhage, etc.).
- •The donor refused to collect lymphocytes to prepare EBV-CTL cells, or the number of EBV-CTL cells prepared from the donor did not meet the infusion requirements.
- •At the same time participate in other clinical studies.
结局指标
主要结局
EBV-DNA
时间窗: 1 year
EBV-DNA negative conversion rate for patients with relapse/non-remission and EBV-DNA reactivation rate for high-risk patients
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study of the Safety and Efficacy of EBV Specific T-cell LinesEpstein-Barr Virus InfectionsLymphomaPost-Transplant Lymphoproliferative DisorderNCT02580539Dr. Jean-Sebastien Delisle, MD, PhD12
撤回
2 期
Safety and Effectiveness of EBV-specific Cytotoxic T Cells for the Treatment for EBV Lymphomas or Other EBV-associated MalignanciesEBV LymphomasEBV-associated MalignanciesNCT03988582Memorial Sloan Kettering Cancer Center
Unknown
1 期
Combined Infusion of Cytotoxic T-Lymphocytes and VaccinationComplication of TransplantNCT02843321University of Sydney12
终止
2 期
Cellular Immunotherapy for Viral Induced Cancer - EBV Positive LymphomasLymphoma, Large B-Cell, DiffusePost-transplant Lymphoproliferative DisorderHodgkin LymphomaNCT02763254Cell Medica Ltd1
Unknown
2 期
VT-EBV-N for Treatment of Severe in EBV Positive Extranodal NK/T Cell Lymphoma PatientsExtranodal NK/T-cell LymphomaNCT03671850ViGenCell Inc.48