Randomised Phase 3 Study of Rituximab in High-Risk Patients With Diffuse Large B-Cell Lymphoma Who Received a First-Line Consolidative Chemotherapy With Autologous Stem Cell Transplant (ASCT).
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 430
- 试验地点
- 7
- 主要终点
- - To compare event-free survival of patients randomized to receive Rituximab or no further therapy after HDT
研究概览
简要总结
Rituximab vs observation after high-dose consolidative first-line chemotherapy (HDC) with autologous stem cell transplantation in poor risk diffuse large B-cell lymphoma.
详细描述
This is a multicentric, open-label, randomized clinical study, evaluating the efficacy and the safety of Rituximab After ASCT in patients aged 18 to 59 years with previously untreated High-Risk (aa-IPI 2 or 3 ) Diffuse Large B-Cell Lymphoma .
The duration of the treatment period is approximately 25 weeks and patients are followed until Death.
From 10/99 to 05/03, 476 patients were enrolled. 235 patients were assigned to receive ACE and 241 to ACVBP. Among the 331 patients, in Complete response (CR+CRu) after induction, who received HDC, 269 were randomized (R2) after hematological recovery to receive either rituximab (n=139) or nothing (n=130).
The final analysis was performed in June 2005.
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
- 18 Years 至 59 Years（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).
- •Aged from 18 to 59 years, eligible for transplant.
- •Patient not previously treated.
- •Age adjusted International Prognostic Index equal to 2 or
- •Having previously signed a written informed consent.
- •Women of childbearing potential currently practicing an adequate method of contraception.
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.
- •Poor renal function (creatinin level>150mmol/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.
- •Any serious active disease (according to the investigator's decision).
- •HIV, HTLV1 or HBV related disease.
- •Any organ transplantation before inclusion.
- •Pregnant women.
结局指标
主要结局
- To compare event-free survival of patients randomized to receive Rituximab or no further therapy after HDT
次要结局
- - To compare response rate to induction treatments (ACVBP vs AC/ACE).
- - To evaluate the safety and tolerability of Rituximab
- - To evaluate response rate at the end of treatment.
- - To compare overall survival (ACVBP vs AC/ACE; Rituximab / nothing)