NCT00536393已完成2 期
Phase III Study of Treatment of Disseminated and Agressive Lymphoma R CHOP Versus R CLOP( With Liposomal Doxorubicin)
French Innovative Leukemia Organisation1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2000年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- hematologic toxicity
研究概览
简要总结
Interest of the use of pegylated liposomal doxorubicin (caélyx)
详细描述
R CHOP is a good standard in the treatment of diffuse high grade lymphoma. Howeverin elderly patients it is often toxic, specially with haematologic and cardiac toxicities.
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
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •high grade lymphoma
- •disseminated
- •> 60 years old and < 75
- •informed consent signed
- •cardiac state compatible with antracyclin
- •ECOG </= 2
排除标准
- •patients > 75 years old
- •Cardiac insufficiency
研究组 & 干预措施
Doxorubicine
Active Comparator
CHOP 8 courses every 21 days
干预措施: Doxorubicin (Drug)
Doxorubicine pegylated
Experimental
CLOP 8 courses every 21 days
干预措施: Doxorubicin pegylated (Drug)
结局指标
主要结局
hematologic toxicity
时间窗: 6 months
次要结局
- response rate(6 months)
- EFS and OS(6 months)
- Cardiac toxicity(6 months)
研究者
研究点 (1)
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