NCT00169130已完成2 期
Prospective Study of ACVBP Followed by Autologous Stem Cell Transplantation in Case of BCL-2 Overexpression in Non Previously Treated Patients Aged 60 Years or Less With Low-Intermediate Risk Diffuse Large B-Cell Lymphoma
Lymphoma Study Association8 个研究点 分布在 2 个国家目标入组 300 人开始时间: 1999年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 8
- 主要终点
- Event free survival.
研究概览
简要总结
The primary objective of the study is to evaluate the efficacy of ASCT as consolidation in case of bcl-2 overexpression in non previously treated patients aged 60 years or less with low-intermediate risk diffuse large B-cell lymphoma who responded to ACVBP regimen. Our goal is to obtain a 15% increase of event-free survival at 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with diffuse large B-cell lymphoma according to the WHO classification (anti CD20 labeling)
- •Aged 18 to 60 years
- •Non previously treated
- •With one and only one of the following adverse characteristics: ECOG performance status 2 or more, or Ann Arbor stage III or IV, or elevated LDH level
- •Negative HIV, HBV and HCV serologies (except vaccination)
- •With a minimum life expectancy of 3 months
- •Having previously signed a written informed consent
排除标准
- •Any history of treated or non-treated indolent lymphoma.
- •T-cell lymphoma.
- •Central nervous system or meningeal involvement by lymphoma.
- •Any Contra-indication to any drug contained in the chemotherapy regimens.
- •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.
- •Serious active disease (according to the investigator's decision).
- •Poor bone marrow reserve as defined by neutrophils <1.5G/l or platelets<100G/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.
- •Childbearing woman.
- •Patients previously treated with an organ transplantation.
结局指标
主要结局
Event free survival.
次要结局
- Complete response rate at the end of treatment.
- Disease-free survival for complete responders.
- Overall survival.
研究者
研究点 (8)
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