NCT01958996已完成1 期
Phase I/II Study of Escalating Doses of Idarubicin Orally Given With Oral Cyclophosphamide, Etoposide, Prednisolone and Intravenous Rituximab in Elderly Patient With Disseminated High Grade Non Hodgkin Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose of idarubicin
研究概览
简要总结
R-CHOP with doxorubicin is the standard first line treatment of high grade non-Hodgkin's lymphoma. In order to avoid central venous system insertion and reduce hospitalization time in elderly patients, we developed an oral chemotherapy treatment: " OROCIEP"trial.
Nineteen patients were enrolled and 127 chemotherapy cycles were available for toxicities. The estimated two-years overall survival was 74%. The main haematological toxicity was neutropenia.
This study is still ongoing to confirm recommended dose of oral anthracycline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CD20-positive diffuse large B-cell lymphoma.WHO classification (55)
- •Written informed consent
- •Age > 65 and < 80 years
- •Performance status (ECOG) <3
- •measurable disease
- •Serology HIV negative, Hepatites B, Hepatites C negative
排除标准
- •Serology HIV positive, Hepatite B positive, Hepatite C positive
- •Cardiac failure.
研究组 & 干预措施
idarubicin
Experimental
干预措施: idarubicin (Drug)
结局指标
主要结局
Maximum tolerated dose of idarubicin
时间窗: 9 months
次要结局
- Remission rate after 4 cycles and 8 cycles(9 months)
研究者
研究点 (1)
Loading locations...
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