Manteau 2007 SJ "LYMA" "Randomized, Open-label, Phase III Study Efficacy of Rituximab Maintenance Therapy in Patients 18 to 65 Years , First-line Treatment for MCL
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 299
- 试验地点
- 1
- 主要终点
- event-free survival (EFS) post Rituximab maintenance therapy
研究概览
简要总结
Randomized, open-label, phase III study to evaluate the efficacy of rituximab maintenance therapy in patients aged between 18 and 65 years inclusive undergoing first-line treatment for mantle cell lymphoma and exhibiting a response after autologous transplantation.
详细描述
Demonstration of the superiority in terms of 4-year event-free survival (EFS) of Rituximab maintenance therapy compared to post-autograft surveillance in patients aged 18-65 years inclusive, treated with R-DHAP then autologous transplantation for MCL as first-line therapy.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mantle cell lymphoma
- •Initial immunophenotyping with CD20 and CD
- •t (11;14) by karyote, FISH, molecular biology or immunohistochemistry (Bcl-1)
- •Patient no previous treated.
- •At least one tumor site accessible for assessment
- •Aged > 18 years < 65
- •ECOG < or =
- •No other neoplasms apart from resected basal cell carcinoma or in situ carcinoma.
- •signed informed consent
排除标准
- •other type of lymphoma
- •ECOG > or = 3
- •serology VIH + Hepatite +
研究组 & 干预措施
1
observation : 3 years maintenance period with assesments and surveillance every 2 months
干预措施: Watch and wait (Other)
2
maintenance period infusions of Rituximab 375 mg/m2/2 months and assessement and surveillance
干预措施: Rituximab (Drug)
结局指标
主要结局
event-free survival (EFS) post Rituximab maintenance therapy
时间窗: EFS post 4 years after maintenance
次要结局
- duration of OS of the entire group of patients(safety/efficacy of treatment)
- complete, partial and overall response rate after induction with R-DHAP and after ASCT.(safety/efficacy of all the treatment)
- duration of PFS of the entire group of patients.(Safety/efficacy of maintenance treatment)