NCT00177554已完成2 期
Phase II Trial of CHOP-R Followed by Zevalin and Rituxan in Follicular Lymphoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Complete response rate
研究概览
简要总结
The purpose of this study is to determine the complete response rate when CHOP-R chemotherapy in followed by Zevalin in previous untreated patients with follicular lymphoma
详细描述
Patients with follicular lymphoma who require therapy and have been previously untreated are eligible for this non-randomized, phase II study evaluating up front therapy with CHOP-R x 3 cycles followed by zevalin and 4 additional weeks of rituxan.The complete response will be determined by combining IWC criteria and PET scanning.Secondary objectives include PET-CT conversion rate, frequency and severity of adverse events, duration of complete remission and time to next lymphoma therapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Conformed diagnosis of follicular lymphoma, grades 1,2 or 3
- •No prior chemotherapy
- •No prior monoclonal antibody therapy
- •Bulky or symptomatic disease, stage II-IV
- •Performance status 0-2
排除标准
- •Impaired bone marrow reserve
- •Presence of CNS lymphoma
- •Serious nonmalignant disease or active infection
结局指标
主要结局
Complete response rate
时间窗: May 2007,May 2008, May2009, May 2010
次要结局
- Time to next lymphoma therapy(May 2207,May2008,May2009, May2010)
- PET-CT conversion rate(May2007)
- Frequency and severity of adverse events(May 2007)
- Duration of complete response(May 2007,May 2008, May 2009, May 2010)
研究者
研究点 (2)
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