NCT00140569已完成3 期
Randomized Study for Patients With Follicular Lymphoma Needing Treatment
Lymphoma Study Association14 个研究点 分布在 2 个国家目标入组 400 人开始时间: 1994年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 14
- 主要终点
- Progression-free survival
研究概览
简要总结
2 parallel studies.
- For young patients (18-60 years): randomization between CHVP + interferon for 18 months and 4 CHOP followed by autotransplant after TBI
- For elderly patients (>60 years): randomization between CHVP + interferon for 18 months and fludarabine 5 days every months for 6 months
详细描述
2 parallel studies.
- For young patients (18-60 years): randomization between CHVP + interferon for 18 months and 4 CHOP followed by autotransplant after TBI
- For elderly patients (>60 years): randomization between CHVP + interferon for 18 months and fludarabine 5 days every months for 6 months
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
- •study 1 (young patients): being less than 61 years old with a follicular lymphoma and needing to be treated because of high LDH level, high beta-2 microglobulin level, poor performance status, or large tumoral mass (lymph node >7 cm, symptomatic splenomegaly, pleura effusion, or sign of compression by the tumor mass)
- •study 2 (elderly patients): being older than 60 years with a follicular lymphoma and needing to be treated because of high LDH level, high beta-2 microglobulin level, poor performance status, or large tumoral mass (lymph node >7 cm, symptomatic splenomegaly, pleura effusion, or sign of compression by the tumor mass)
排除标准
- •contra-indication to anthracycline or interferon
- •transformation into large cell lymphoma
- •previous treatment
- •localized stage without criteria of large tumor mass
- •patients HIV+
结局指标
主要结局
Progression-free survival
次要结局
- Overall survival
- Toxicity
- Response rates
研究者
研究点 (14)
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