A Randomized, Controlled, Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of the Purinostat Mesylate for Injection (PM) Compared to Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 390
- 试验地点
- 1
- 主要终点
- The Overall Survival
研究概览
简要总结
The main objective of this study is to evaluate the differences in objective response rate and overall survival between the Purinostat mesylate for injection and selinexor, as assessed by blinded independent central review (BICR), in patients with relapsed or refractory diffuse large B-cell lymphoma.
.The participants in the experimental group will receive treatment with Purinostat mesylate for injection. The dosage is 11.2 mg/m2. Each administration cycle consists of intravenous administration on days 1, 4, 8, and 11. A 21-day period constitutes one treatment cycle, and the total treatment cycle lasts for 6 cycles.
.Participants in the control group will receive selinexor treatment. The recommended dose is 60 mg per dose, taken orally on days 1 and 3 of each week (for example, Monday and Wednesday, or Tuesday and Thursday), and a 4-week period constitutes one treatment cycle.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years, no gender restrictions;
- •Histologically-confirmed DLBCL, Participants must have relapsed or failed to respond to at least two lines of prior systemic therapy (2-5 lines);
- •Participants must have measurable disease;
- •Adequate organ function
排除标准
- •Pregnancy or breastfeeding;
- •Previous history of transplantation;
- •Double/Triple Hit B cell lymphoma;
- •Patient with known active infection, or reactivation of a latent infection;
- •Any serious diseases that investigator deems inappropriate to participate.
研究组 & 干预措施
Control group
干预措施: Selinexor Tablets (Drug)
experimental group
干预措施: Purinostat Mesylate for Injection (Drug)
结局指标
主要结局
The Overall Survival
时间窗: week 96
The Overall Survival
次要结局
- The PFS assessed by BICR AND Investigator according to Lugano 2014(week 96)
- The ORR assessed by BICR and Investigator according to Lugano 2014(week 96)