Randomized Study of ACVBP Plus Rituximab Versus CHOP Plus Rituximab in Non Previously Treated Patients Aged From 60 to 65 Years With Diffuse Large B-Cell Lymphoma
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 138
- 试验地点
- 8
- 主要终点
- event free survival
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone (ACVBP) plus rituximab in comparison to cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) plus rituximab in patients aged from 60 to 65 years with non-previously treated diffuse large B-cell lymphoma as measured by the event-free survival. The goal is to obtain a 10% increase of event-free survival at 3 years.
详细描述
In Europe, 50% or more of new non-Hodgkin lymphoma cases occur in patients older than 60 years. More than 30% are diffuse large B-cell lymphomas (DLCL).
The CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine, prednisone) was considered as the standard treatment in this population. Nevertheless, this treatment is associated with some toxic events in elderly patients and it did does not succeed to increase the 3-year survival rate above 40%.
Two trials in patients above 60 years with DLCL cases were conducted by the GELA in the aim to improve the results of CHOP.
Protocol LNH 93-5 : The primary objective of this study was to compare CHOP to ACVBP in patients aged from 61 to 69 years with aggressive lymphoma and at least one adverse prognostic factor according to the International Prognostic Index.
Unlike the CHOP regimen, the ACVBP regimen includes a more intensive induction followed by a sequential consolidation with drugs different from those used during the induction phase, and includes a prevention of neuromeningeal relapses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 65 Years（Adult, Older 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 from 60 to 65 years.
- •Not previously treated.
- •Ann Arbor stage II, III, IV.
- •ECOG performance status 0 to
- •Minimum life expectancy of 3 months.
- •Negative HIV, hepatitis B virus (HBV) and hepatitis C virus (HCV) serologies test 4 weeks (except after vaccination).
- •Having previously signed a written informed consent.
排除标准
- •T-cell lymphoma.
- •Any history of treated or non-treated indolent lymphoma. However, patients not previously diagnosed and having a diffuse large B-cell lymphoma with some small cell infiltration in bone marrow or lymph node may be included.
- •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 (creatinine level>150micromol/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<1.5G/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.
- •Adult patient under tutelage.
研究组 & 干预措施
R-CHOP
Rituximab, Doxorubicin, Cyclophosphamide, Vincristine, Prednisone
干预措施: Vincristine (Drug)
R-ACVBP
Rituximab, Doxorubicin, Cyclophosphamide, Vindesine, Bleomycin, Prednisone
干预措施: Rituximab (Drug)
R-ACVBP
Rituximab, Doxorubicin, Cyclophosphamide, Vindesine, Bleomycin, Prednisone
干预措施: Doxorubicin (Drug)
R-ACVBP
Rituximab, Doxorubicin, Cyclophosphamide, Vindesine, Bleomycin, Prednisone
干预措施: Cyclophosphamide (Drug)
R-ACVBP
Rituximab, Doxorubicin, Cyclophosphamide, Vindesine, Bleomycin, Prednisone
干预措施: Vindesine (Drug)
R-ACVBP
Rituximab, Doxorubicin, Cyclophosphamide, Vindesine, Bleomycin, Prednisone
干预措施: Bleomycin (Drug)
R-ACVBP
Rituximab, Doxorubicin, Cyclophosphamide, Vindesine, Bleomycin, Prednisone
干预措施: Prednisone (Drug)
R-CHOP
Rituximab, Doxorubicin, Cyclophosphamide, Vincristine, Prednisone
干预措施: Rituximab (Drug)
R-CHOP
Rituximab, Doxorubicin, Cyclophosphamide, Vincristine, Prednisone
干预措施: Prednisone (Drug)
R-CHOP
Rituximab, Doxorubicin, Cyclophosphamide, Vincristine, Prednisone
干预措施: Doxorubicin (Drug)
R-CHOP
Rituximab, Doxorubicin, Cyclophosphamide, Vincristine, Prednisone
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
event free survival
时间窗: 8 years (end of study)
percentage of patients alive with no event
次要结局
- overall survival(8 years (end of study))
- number of SAE(8 years (end of study))
- complete response rate(8 years (end of study))
- progression rate(8 years (end of study))
- neuromeningeal relapse rate(8 years (end of study))
- relapse rate(8 years (end of study))
- disease-free survival for complete responders(8 years (end of study))