Phase II Study With Rituximab and CHOP in Patients With Gastric Diffuse Large B-Cell Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 9
- 主要终点
- Complete remission rate
研究概览
简要总结
The optimal treatment of primary gastric diffuse large B-cell lymphoma (PG-DLBCL) has not yet been defined. In most circumstances, a stomach-conserving approach is favored, but the role of radiotherapy is still a matter of debate. Recently, Rituximab along with full-dose CHOP chemotherapy has been shown to improve the outcome in elderly patients with nodal DLBCL. However, no data are available with such a therapy in patients with PG-DLBCL. Therefore, in March 2003, we initiated an ongoing, prospective, multicenter phase II study in patients with PG-DLBCL with 6 to 8 cycles of Rituximab (R; 375 mg/m2) plus CHOP-21 in order to evaluate the safety and efficacy of this approach.
详细描述
see above
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
- •Age > 18 years
- •Histologically confirmed primary gastric CD20+ DLBCL
- •Written informed consent
排除标准
- •Secondary aggressive Non-Hodgkin's lymphoma involving the gastric area
- •HIV positive patients
- •Severe organ dysfunction
- •Life expectancy of less than 3 months
结局指标
主要结局
Complete remission rate
时间窗: at end of chemo-immunotherapy
Progression-free survival
时间窗: at 2 and 5 years
次要结局
- Overall survival(at 2 and 5 years)
- Toxicity(after chemo-immunotherapy)