CTRI/2015/05/005811已完成3 期
A phase 3, randomized, double-blind study of PF-05280586 versus Rituximab for the first-line treatment of patients with CD20-positive, low tumor burden, follicular lymphoma - REFLECTIONS B328-06
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Confirmed diagnosis of low tumor burden, CD20-positive follicular lymphoma (containing no elements of diffuse large B-cell lymphoma)
- •Ann Arbor Stage II, III, or IV
- •Eastern Cooperative Oncology Group (ECOG) status of 0 to 1
- •At least 1 measureable disease lesion of at least 1.5 cm in longest diameter
排除标准
- •Not a candidate for treatment with rituximab as a single-agent
- •Evidence of transformation to a high grade or diffuse large B-cell lymphoma
- •Central nervous system or meningeal involvement or cord compression by the lymphoma.
- •T-cell lymphoma.
- •Any prior treatment for lymphoma
- •Any prior treatment with rituximab
- •Active, uncontrolled infection
研究者
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