Comparing Two Schedules of Rituximab Maintenance in Rituximab-Responding Patients With Untreated, Chemotherapy Resistant or Relapsed Follicular Lymphoma: A Randomized Phase III Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 51
- 主要终点
- Event-free survival
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether giving rituximab over a short period of time is more effective than giving it over a long period of time in treating follicular non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying rituximab to see how well it works when given over a short period of time compared to when given over a long period of time in treating patients with follicular non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
Primary
- Compare the efficacy of induction therapy with rituximab followed by short- vs long-term maintenance therapy with rituximab, in terms of event-free survival, in patients with follicular non-Hodgkin's lymphoma.
Secondary
- Compare the safety of these regimens in these patients.
- Compare the pharmaeconomical aspects of these regimens in these patients.
- Compare the evolution of immunologic competence in patients treated with these regimens.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A: Rituximab every 2 months x4
Rituximab 375 mg/m2 every 2 months x4
干预措施: rituximab (Biological)
Arm B: Rituximab (5 years)
Rituximab 375 mg/m2 every 2 months for 5 years or until PD, relapse or unacceptable toxicity
干预措施: rituximab (Biological)
结局指标
主要结局
Event-free survival
时间窗: at 10 years
次要结局
- Overall survival(at 10 years)
- Progression-free survival(at 10 years)
- Adverse reactions during and after maintenance treatment(10 years)