NCT00276003已完成2 期
INST Phase II Trial of Gemcitabine and Irinotecan in Patients With Relapsed or Refractory 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
- 22
- 试验地点
- 4
- 主要终点
- Assess the response rate in patients with recurrent or refractory B-cell NHL or Hodgkins disease, treated with the combination of the gemcitabine and irinotecan.
研究概览
简要总结
Primary objectives
- Assess the response rate in patients with recurrent or refractory B-cell NHL or Hodgkins disease, treated with the combination of the gemcitabine and irinotecan.
Secondary objectives
- Assess progression free survival in these patients treated with this regimen.
- Assess toxicity of this regimen in this group of patients.
详细描述
The purpose of the study is to see how well patients with relapsed or refractory lymphoma respond to treatment with Gemcitabine and Irinotecan. Patients on this study take part because they have relapsed or refractory lymphoma. Additionally, the study will assess treatment-related side effects and time until disease progression or recurrence.
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
- •Patients with a histologic diagnosis of non-HIV related B-cell NHL or Hodgkins disease are eligible.
- •Patients should have documented evidence of refractory or relapsed NHL or Hodgkins disease for inclusion.
- •Patient should have received 1 or more prior chemotherapeutic regimens for relapse, and should have completed last course of treatment at least 3 weeks prior to enrollment.
- •The patient must have bidimensionally measurable or evaluable disease.
- •Age > 18 years.
- •ECOG Performance status < 2
- •Informed consent.
- •ANC > 1.5, platelet count > 100K, creatinine< 2.0, bilirubin < 3
- •Female patients must have a negative pregnancy test.
排除标准
- 未提供
结局指标
主要结局
Assess the response rate in patients with recurrent or refractory B-cell NHL or Hodgkins disease, treated with the combination of the gemcitabine and irinotecan.
时间窗: 3 years
次要结局
- Assess progression free survival in these patients with this regimen.(3 years)
- Assess toxicity of this regimen in this group of patients.(3 years)
研究者
研究点 (4)
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