PD-1 Inhibitor Tislelizumab Maintenance Therapy in Newly Diagnosed DLBCL Patients After ASCT: A Multicenter, Randomized Controlled Clinical Study on Efficacy and Safety
试验速览
- 阶段
- 3 期
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
This is a multicenter, randomized controlled, prospective clinical trial. The objective is to investigate the efficacy and safety of Tislelizumab maintenance therapy in newly diagnosed diffuse large B-cell lymphoma (DLBCL) patients after autologous hematopoietic stem cell transplantation (ASCT).
详细描述
This is a multicenter, randomized controlled, prospective clinical trial. The objective is to investigate the efficacy and safety of Tislelizumab maintenance therapy in newly diagnosed diffuse large B-cell lymphoma (DLBCL) patients after autologous hematopoietic stem cell transplantation (ASCT). 94 patients were randomly divided into two groups according to the ratio of 1:1. The whole trial included screening period (day-28 to day-1), treatment period (Tislelizumab, 200mg every 8 weeks, 12 times) and follow-up period (2 years after the enrollment).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female, aged 18-65;
- •newly-diagnosed high risk (aaipi 2-3 and aaipi 1 with large mass) DLBCL patients after autologous stem cell transplantation;
- •Laboratory tests (blood tests, liver and renal function) meet the following requirements:
- •Blood tests: white blood cell count ≥ 3.0 × 109 / L, absolute neutrophil count ≥ 1.5 × 109 / L, hemoglobin ≥ 90g / L, platelet ≥ 75 × 109 / L
- •Liver function: transaminase ≤ 2.5 × upper limit of normal value, bilirubin ≤ 1.5 × upper limit of normal value;
- •Renal function: serum creatinine 44-133 mmol / L;
- •The score of ECOG was 0-2;
- •The subject or his legal representative must provide written informed consent before the special examination or procedure of the study.
排除标准
- •Pregnant or lactating women;
- •Severe complications or infection;
- •Lymphoma involving central nervous system;
- •Participate in other clinical trials at the same time;
- •According to the judgment of the researcher, the patients who are not suitable for this study were selected.
研究组 & 干预措施
PD-1 Inhibitor maintenance
PD-1 Inhibitor Tislelizumab maintenance therapy dose：200mg frequency：1 time for 2 months duration：2 years
干预措施: PD-1 Inhibitor Tislelizumab maintenance therapy (Drug)
结局指标
主要结局
progression-free survival
时间窗: 2-years after enrollment
Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria,or death from any cause, whichever occurred first.
次要结局
- complete remission rate(2-years after enrollment)
- overall survival(2-years after enrollment)