NCT04069845Unknown不适用
A Registry Study on the Risk Factors of Interstitial Pneumonia in Lymphoma Patients Treated With Liposomal Doxorubicin
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- the incidence of interstitial pneumonia
研究概览
简要总结
This study is to evaluate the incidence of interstitial pneumonia in lymphoma patients treated with liposomal doxorubucin. The treatment response and other adverse events will also be studied.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed lymphoma
- •18-80 years
- •ECOG<= 2
- •newly diagnosed lymphoma
- •liposomal doxorubicin is planned in the treatment
- •normal lung function
- •no history or malignancy
- •informed consented
排除标准
- •history of malignancy, now in the treatment
- •serious infection
- •other uncontrollable conditions judged by the investigator
研究组 & 干预措施
liposomal doxorubicin treatment
intravenous liposomal doxorubicin
干预措施: liposomal doxorubicin (Drug)
结局指标
主要结局
the incidence of interstitial pneumonia
时间窗: up to one month after completion of study treatment
interstitial pneumonia is defined as positive CT scan with or without positive respiratory symptoms
次要结局
- adverse events(up to 30 days after completion of study treatment)
- overall response rate(21 days after completion of study treatment)
研究者
研究点 (1)
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