NL-OMON41828已完成2 期
A phase II study of obinutuzumab monotherapy in rituximab-refractory follicular lymphoma - ZO
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- biopsy -proven rituximab refractory follicular lymphoma
- •- no transformation to high grade or diffuse large B cell lymphoma
- •- radiographicaly documented measurable disease (2 or more clearly demarcated lesions with a largest diameter of at least 1.5 cm, or 1 clearly demarcated lesion with a largest diameter of at least 2 cm).
- •- adult patients, older than 18 years
- •-ECOG performance score 0,1 or 2
- •-written informed consent according to GCP
排除标准
- •-known central nervous system involvement
- •-concurrent use of other anti-cancer agents
- •-all other lymphoma treatment (except rituximab maintenance therapy) during the last 6 months
- •-other active malignancy
- •-pregnant and breastfeeding women, and subjects of childbearing potential without adequate and effective contraception
- •- life expectancy less than 6 months
- •- active infectious disease (see protocol for definition)
- •- clinical significant cardiovascular disease
- •- abnormal laboratory values at screening (see protocol for definition)
研究者
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