NCT06045195尚未招募2 期
Phase II Trial of Pembrolizumab in First-Line Treatment of Advanced-Stage Classical Hodgkin Lymphoma
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- progression free survival
研究概览
简要总结
The primary objective of this trial is to estimate efficacy of the novel regimen. The primary endpoint is the 1-year PFS rate after treatment with one dose of pembrolizumab followed by four to six cycles of chemo-immunotherapy with P-BrECADD, and PET-guided radiotherapy as per standard of care
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-60
- •advanced stage classical Hodgkin Lymphoma
- •no previous treatment for cHL
排除标准
- •Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma
- •Chemotherapy or radiotherapy in medical history
- •Prior or concurrent disease that prevents treatment according to protocol
研究组 & 干预措施
Treatment
Experimental
Pembrolizumab + BrECADD
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
progression free survival
时间窗: 1 year
次要结局
未报告次要终点
研究者
Prof. Dr. Peter Borchmann
Prof.
University of Cologne
研究点 (1)
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