A Phase II Trial to Investigate the Safety and Efficacy of Rituximab and Pembrolizumab in Relapsed/Refractory Waldenström's Macroglobulinaemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 9
- 主要终点
- Percentage of Patients Achieving at Least a Major Response Rate at 24 Weeks Post Commencing Treatment
研究概览
简要总结
This study is for patients who have previously been treated for Waldenström's macroglobulinaemia (WM) and their disease has either not responded (known as refractory disease) or has returned (known as relapsed disease). Through this study, the researchers would like to find out whether treating these patients with drugs called rituximab and pembrolizumab is a safe and effective combination for this disease.
In this study, pembrolizumab and rituximab will be given together. In other studies pembrolizumab has been shown to be effective at treating diseases similar to WM. The researchers want to test whether giving pembrolizumab and rituximab together is safe and effective.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Pembrolizumab and Rituximab
干预措施: Pembrolizumab (Drug)
Pembrolizumab and Rituximab
干预措施: Rituximab (Drug)
结局指标
主要结局
Percentage of Patients Achieving at Least a Major Response Rate at 24 Weeks Post Commencing Treatment
时间窗: 24 weeks
The primary outcome is the percentage of patients achieving at least a major response rate at 24 weeks post commencing treatment. A major response rate is defined as a greater than 50% reduction in paraprotein measurement - this is in line with international recognised response criteria for the disease under investigation. In this single arm study all patients receiving treatment were considered applicable for endpoint analysis. There is no comparison as there is only one arm.
次要结局
- Safety and Tolerability of Pembrolizumab and Rituximab as Assessed by the Frequency of Serious and Non-serious Adverse Events, According to CTCAE v5.0(until 5 months post last IMP administration)
- Complete Response Rate at 24 Weeks Post Commencing Treatment(24 weeks)
- Very Good Partial Response Rate at 24 Weeks Post Commencing Treatment(24 weeks)
- Time to Maximal Response as Determined by the Time of Registration to the Maximal Disease Response(Assessed at 12 weeks, 24 weeks and 1 year after commencing treatment)
- Time to Next Treatment(Assessed once per year after completing treatment (average of 1 year))
- Progression Free Survival (PFS) at 1 and 2 Years(1 and 2 years post commencing treatment)
- Overall Survival (OS) at 1 and 2 Years(1 and 2 years post commencing treatment)
- Quality of Life - Change in Quality of Life (QoL) at 24 Weeks Post Commencing Treatment as Assessed by EORTC QLQ-C30 Questionnaire(24 weeks)