NCT00515554已完成3 期
HD18 for Advanced Stages in Hodgkins Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
This study is designed to test:
- in patients with negative positron-emission tomography (PET) after 2 cycles of BEACOPPesc chemotherapy: whether the number of cycles can be reduced without compromising progression free survival (PFS) (2 further cycles vs. 6 further cycles)
- for patients with positive PET after 2 cycles: whether intensifying BEACOPPesc chemotherapy by adding Rituximab improves PFS.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hodgkin Lymphoma (histologically proven)
- •CS (PS) IIB with one or both of the risk factors:
- •bulky mediastinal mass (> 1/3 of maximum transverse thorax diameter)
- •extranodal involvement
- •CS (PS) III, IV
- •Written informed consent
排除标准
- •Leucocytes < 3000/µl
- •Platelets < 100000/µl
- •Hodgkin´s lymphoma as "composite lymphoma"
- •Activity index (WHO) < grade 2
研究组 & 干预措施
A
Active Comparator
8 cycles BEACOPPesc
干预措施: BEACOPP escalated (Drug)
B
Experimental
8 cycles BEACOPPesc plus rituximab
干预措施: Rituximab (Drug)
B
Experimental
8 cycles BEACOPPesc plus rituximab
干预措施: BEACOPP escalated (Drug)
C
Active Comparator
8 cycles BEACOPPesc
干预措施: BEACOPP escalated (Drug)
D
Experimental
4 cycles BEACOPPesc
干预措施: BEACOPP escalated (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: 5 years
次要结局
- Overall Survival(5 years)
- acute toxicity(5 years)
- late toxicity(5 years)
- CR-rate(5 years)
研究者
Prof. Dr. Andreas Engert
Prof.
University of Cologne
研究点 (1)
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