EUCTR2007-001589-34-BE进行中（未招募）1 期
Phase II study of mini CHOP plus Rituximab in non previously treated patient aged over 80 years with CD20+ Diffuse Large B-cell Lymphoma - LNH03-7B
GELA Group0 个研究点目标入组 150 人开始时间: 2007年4月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
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
- 性别
- All
入选标准
- •- Patient with histologically proven CD20+ diffuse large B-cell lymphoma
- •- aged over 80 years
- •- Ann Arbor stage Ibulky, II, III or IV
- •- Age-adjusted International Prognostic Index equal to 1, 2 and 3
- •- Patient not previously treated
- •- ECOG performance status <= 2
- •- with a minimum life expectancy of 3 months
- •- Negative HIV, HBV and HCV serologies test <= 4 weeks
- •- Having previously signed a written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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
- •- Any other histological type of lymphoma
- •- Any history of treated or non-treated
- •- central nervous system or meningeal involvement by lymphoma
- •- contra-indication to any drug contained in the chemotherapy regimens
- •- any serious active disease
- •- Poor renal function, poor hepatic function unless these abnormalities are related to the lymphoma.
- •- poor bone marrow reserve as defined by neutrophils <1.5 G/l or platelets< 100 G/l, unless related to bone marrow infiltration
- •- Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage o cervical carcinoma
- •- Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study
- •- Adult patient under tutelage
研究者
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