NCT01087424已完成2 期
Phase II Study of Mini-CHOP Plus Rituximab in Non Previously Treated Patients Aged Over 80 Years With CD 20+ Diffuse Large B-Cell Lymphoma
Lymphoma Study Association0 个研究点目标入组 150 人开始时间: 2006年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 主要终点
- Evaluating efficacy of R-miniCHOP by overall survival
研究概览
简要总结
The purpose of the study is to evaluate efficacy and safety of R-miniCHOP for elderly patients with diffuse large B-Cell lymphoma (DLBC) Lymphoma aged over 80 years by measuring the overall survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with histologically proven CD20+ diffuse large B-cell lymphoma (WHO classification). DLBCL with some small cell infiltration in bone marrow or lymph node may be included.
- •Aged over 80 years.
- •Ann Arbor stage I bulky, II, III or IV
- •Age-adjusted International Prognostic Index equal to 0, 1, 2 and
- •Patient non previously treated.
- •ECOG performance status ≤
- •With a minimum life expectancy of 3 months.
- •Negative HIV, HBV and HCV serologies test ≤ 4 weeks (except after vaccination).
- •Having previously signed a written informed consent
排除标准
- •Any other histological type of lymphoma.
- •Any history of treated or non-treated indolent lymphoma.
- •Central nervous system or meningeal involvement by lymphoma.
- •Contra-indication to any drug contained in the chemotherapy regimens.
- •Any serious active disease (according to the investigator's decision).
- •Poor renal function (creatinin level>150µmol/l), poor hepatic function (total bilirubin level>30mmol/l, transaminases>2.5 maximum normal level) 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 0 (in situ) cervical carcinoma.
- •Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
- •Adult patient under tutelage.
研究组 & 干预措施
R mini CHOP
Experimental
Induction : 3 cycles every 3 weeks Consolidation :3 cycles every 3 weeks
干预措施: R mini CHOP (Drug)
结局指标
主要结局
Evaluating efficacy of R-miniCHOP by overall survival
时间窗: 2 years overall survival
次要结局
- Evaluating R-miniCHOP efficacy by Event free survival(2 years event free survival)
研究者
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