NCT00491127已完成2 期
Phase II Study of Cisplatin With Gemcitabine in Fixed Dose Rate Infusion and Dexamethasone in Second-Line in Patients With Aggressive Non-Hodgkin's 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
- 10
- 试验地点
- 1
- 主要终点
- To evaluate response rate
研究概览
简要总结
The purpose of this study it to evaluate efficacy of gemcitabine with cisplatin and dexamethasone in patients with aggressive non-Hodgkin's lymphoma who have previously progressed on first line of chemotherapy with anthracyclines.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •The patients must have a histological diagnosis of aggressive non-Hodgkin's lymphoma including the following sub-categories of the WHO classification:
- •Diffuse large B-cell lymphoma and its variants (immunoblastic, Burkitt-like, sclerosis of mediastinum, large B-cell MALT, rich in T-cells and anaplastic B-cell lymphoma)
- •Peripheral T-cell lymphoma
- •Anaplastic lymphoma of large T-cells /null cells
- •Patients are eligible if they have documented evidence of progression after prior first-line chemotherapy containing anthracyclines associated or not with Rituximab. Patients with refractory disease to first line of treatment are also eligible.
- •ECOG PS (performance status) less than or equal to 2
- •Presence of bidimensionally measurable disease in accordance with WHO criteria.
排除标准
- •Involvement of the CNS.
- •Any medical condition which contraindicates the degree of hydration required for the safe use of cisplatin.
- •Intermediate degree lymphoma derived from the malignant transformation of a previous low-grade lymphoma.
- •Active infection (in the opinion of the investigator).
结局指标
主要结局
To evaluate response rate
次要结局
- To assess toxicity
- Overall survival
- Event-free survival
- Progression - free survival
- Disease - free survival
- Duration of response
研究者
研究点 (1)
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