A Multicenter, Single-Arm, Prospective Clinical Study to Evaluate the Efficacy and Safety of PD-1 Inhibitor Combined With Tenofovir, Chidamide, and Lenalidomide in the Treatment of EBV-Associated Diseases
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Overall Response Rate (ORR), including Complete Response (CR) and Partial Response (PR), based on EBV-DNA levels.
研究概览
简要总结
Currently, treatment options for Epstein-Barr virus (EBV) infection are limited, with unsatisfactory efficacy and no established standard therapy. Therefore, our center is conducting a prospective, multicenter, single-arm clinical trial to evaluate the efficacy and safety of PD-1 inhibitor in combination with tenofovir, chidamide, and lenalidomide in patients with EBV infectious diseases, aiming to provide a more effective and safer therapeutic option for EBV infectious diseases.
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 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with EBV infectious diseases, including infectious mononucleosis, chronic active EBV infection, or other EBV infectious diseases;
- •EBV DNA ≥ 10⁴ copies/mL in whole blood or plasma;
- •Age ≤ 75 years with ECOG performance status ≤ 2;
- •Estimated life expectancy over 3 months;
- •Patients must be able to undergo follow-up. They should understand the nature of their disease and voluntarily agree to participate in this study for treatment and follow-up.
排除标准
- •Patients with impaired liver or kidney function, specifically defined as serum direct bilirubin, indirect bilirubin, and/or ALT, AST, or serum creatinine >2 times the upper limit of normal (ULN), unless such abnormalities are attributed to lymphoma;
- •Patients with bone marrow failure, defined as absolute neutrophil count (ANC) <1.5×10⁹/L or platelets <75×10⁹/L;
- •Patients who have experienced grade III or higher neurotoxicity within the past 2 weeks;
- •Patients with chronic heart failure classified as NYHA class III or IV, or left ventricular ejection fraction (LVEF) <50%, or those with a history of the following cardiac events within the past 6 months: acute coronary syndrome, acute heart failure (NYHA class III or IV), or significant ventricular arrhythmias (sustained ventricular tachycardia, ventricular fibrillation, or resuscitated sudden cardiac arrest);
- •Patients with AIDS, syphilis, or active hepatitis B (HBV DNA >1×10⁴ copies/mL) or hepatitis C infection;
- •Patients with coexisting hematologic disorders (e.g., hemophilia, myelofibrosis) deemed unsuitable for inclusion by the investigator;
- •Patients with severe concurrent infections;
- •Patients who have undergone grade II or higher surgery within 3 weeks prior to treatment;
- •Patients with substance abuse, medical, psychological, or social conditions that may interfere with study participation or the evaluation of study outcomes;
- •Patients deemed unsuitable for enrollment by the investigator;
- •Patients with known hypersensitivity to components of the investigational drug.
研究组 & 干预措施
Evaluate efficacy and safety of multi-drug therapy in EBV infectious diseases.
To investigate the therapeutic effect of PD-1 inhibitor combined with tenofovir, chidamide, and lenalidomide in EBV infectious diseases, and to evaluate its safety and clinical benefit in this patient population.
干预措施: PD-1 Inhibitor Combined with Tenofovir, Chidamide, and Lenalidomide for the Treatment of EBV Infectious Diseases. (Drug)
结局指标
主要结局
Overall Response Rate (ORR), including Complete Response (CR) and Partial Response (PR), based on EBV-DNA levels.
时间窗: After 3 months of treatment according to the study protocol, a comprehensive efficacy assessment will be conducted. Patients achieving CR or PR will continue treatment, while those with SD or PD will be withdrawn from the study.
次要结局
- 24-month overall survival rate of EBV-infected diseases.(From first dose until death from any cause (assessed at 24 months）)
- 24-month progression-free survival rate of EBV-infected diseases.(From first dose until first documented progression or death (assessed at 24 months))