NCT00147875已完成1 期
PVAG - Phase I/II Dose Finding Trial in Elderly Patients (> 60 Years) With Advanced Stages Hodgkin's Lymphoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Phase I: Dose-limiting toxicities and dose reductions
研究概览
简要总结
The objectives of this study are to assess the feasibility and efficacy of a combination chemotherapy (PVAG) in elderly patients with advanced stages Hodgkin's lymphoma.
详细描述
Gemcitabine shows promising activity in patients with relapsed lymphoma either administered as single agent or in combination with other cytotoxic agents. No trial to date evaluated its role in patients with primary Hodgkin's lymphoma. We therefore developed a three-weekly regimen based on the standard ABVD regimen.
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
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hodgkin's lymphoma (histologically proven)
- •Clinical stage IIB (with risk factors bulky mediastinal mass and/or extranodal involvement), III, or IV
- •No prior antitumor therapy
- •Age 60 to 75 years
- •WHO performance status 0-2
- •Normal pulmonary function
- •Written informed consent
排除标准
- •The following histologies are excluded: lymphocyte predominant HD
- •Leukocytes < 2,500/microL
- •Platelets < 100,000/microL
结局指标
主要结局
Phase I: Dose-limiting toxicities and dose reductions
Phase II: Treatment administration and complete response rate
次要结局
- Toxicities
- Supportive care (RBCT need, antibiotic need)
- Early progression rate
- Overall survival
研究者
研究点 (2)
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