EUCTR2004-002197-34-GB进行中（未招募）1 期
A phase III multicentre randomised clinical trial comparing rituximab with CHOP given every 14 days and rituximab with CHOP given every 21 days for the treatment of patients with newly diagnosed diffuse large B cell non-Hodgkin’s lymphoma - R-CHOP 14 vs. 21
niversity College London0 个研究点目标入组 1,080 人开始时间: 2005年2月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,080
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •a) Age ? 18 years.
- •b) Histologically proven diffuse large B cell non-Hodgkin’s lymphoma (DLBCL) according to the current World Health Organisation classification14 including all morphological variants. The B cell nature of the proliferation must be verified by the positivity with an anti-CD20 antibody. All histology will be reviewed by a central Lymphoma Trials Office pathology panel.
- •c) Bulky stage IA (defined as lymph node or lymph node mass greater than 10cm in diameter), stage II, stage III and IV.
- •d) No previous chemotherapy, radiotherapy or other investigational drug for this indication.
- •e) Written, informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •a) T-cell lymphoma or transformed follicular lymphoma.
- •b) Previous history of treated or non-treated indolent lymphoma. However, patients not previously diagnosed who have a diffuse large B-cell lymphoma with some small cell infiltration in bone marrow or lymph node may be included.
- •c) Any medical condition compromising ability to tolerate chemotherapy
研究者
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