A Randomized Phase III Study to Compare Conventional Chemotherapy (CHOEP-14) + Rituximab vs High-dose Chemotherapy Followed by Autologous Stem Cell Transplantation (Mega-CHOEP-21) + Rituximab in Younger Patients With Aggressive NHL
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- time to treatment failure
研究概览
简要总结
According to amendment 3 this study addresses the question if intensification of administration of rituximab in standard treatment for patients with newly diagnosed aggressive B-Non Hodgkin Lymphoma (B-NHL) and high risk (aaIPI 2 or 3) results in a better time to treatment failure (TTTF)
详细描述
This study was primarily designed to compare aggressive conventional chemotherapy with a repetitive high-dose (HD) therapy program using identical, effective drugs at highest possible dose and dose intensity with/without addition of rituximab (initially 4 treatment arms). In 2004 the first amendment had to be added in order to close two treatment arms without rituximab due to recent data revealing a significant advantage for rituximab-treated patients with CD20+lymphoma.
A planned interim analysis in 2010 revealed inferiority of the high-dose treatment thus in the 2nd amendment the high-dose arm was closed and additionally the rituximab frequency was raised from 6 to 12 administrations as recent publications gave hint for advantage. The last amendment was added in 2010 to adjust for delayed recruitment mainly due to organisation problems.
As the high-dose arm was closed only CD20+ B-lymphoma were included past amendment 2.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-60 years of age
- •Risk group International Prognostic Index (IPI) 2 and 3 (age adjusted)
- •Performance status: Eastern Cooperative Oncology Group (ECOG) 0-3
- •Patient's written informed consent
- •Aggressive non-Hodgkin's lymphoma with CD20+ histology
排除标准
- •Already initiated lymphoma therapy
- •Serious accompanying disorder or impaired organ function
- •Bone marrow involvement > 25%
- •Known hypersensibility to the medications to be used
- •Known HIV-positivity
- •Active hepatitis infection
- •Suspicion that patient compliance will be poor
- •Simultaneous participation in other trials
- •Prior chemo- or radiotherapy for previous disorder
- •Other concomitant tumour disease
研究组 & 干预措施
R-CHOEP14 with 12x Rituximab
8 cycles of standard CHOP with etoposide in 14-day intervals. Patients with CD20+ lymphoma receive 12 doses of Rituximab (day 0,1,4,8 of cycle 1, day 1 and 8 of cycle 2, day1 of cycle 3-8 )
干预措施: R-CHOEP 14 with 12x Rituximab (Drug)
结局指标
主要结局
time to treatment failure
时间窗: 3 years after study inclusion
At 3 year follow up rate of treatments and time to treatment failure will be determined
次要结局
未报告次要终点