Rituximab Plus Lenalidomide or Rituximab Monotherapy for Untreated Patients With Follicular Lymphoma in Need of Therapy. A Randomized, Open-Label, Multicenter Phase II Trial.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 154
- 试验地点
- 33
- 主要终点
- Complete response (CR)
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer cell 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. Lenalidomide may stop the growth of non-Hodgkin lymphoma by blocking blood flow to the cancer. It is not yet known whether rituximab is more effective when given alone or together with lenalidomide in treating patients with follicular lymphoma.
PURPOSE: This randomized phase II trial is studying rituximab to see how well it works compared with giving rituximab together with lenalidomide in treating patients with previously untreated follicular lymphoma.
详细描述
OBJECTIVES:
Primary
- To determine the activity of rituximab in combination with lenalidomide versus rituximab alone in patients with previously untreated follicular lymphoma in need of therapy.
Secondary
- To determine the safety of these regimens in these patients.
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
Rituximab
Rituximab (MabThera®) will be administered for a maximum of 8 infusions at weeks 1, 2, 3, 4 and again at weeks 12, 13, 14, 15 if the first restaging at week 10 (+/- 1 week) shows a partial response with at least more than 25% reduction in sum of product of diameters
干预措施: Rituximab (Biological)
Rituximab plus Lenalidomide
Lenalidomide will be administered as 15 mg flat dose daily, starting 14 days before first and stopping 14 days after last rituximab administration.
干预措施: lenalidomide (Drug)
结局指标
主要结局
Complete response (CR)
时间窗: at week 23
The evaluation of CR is outlined in Appendix 1 Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma.
次要结局
- Best Overall response (OR)(within 12 weeks)
- Progression-free survival(until disease progression, for up to 10 years after randomization)
- Time to first off-trial anti-lymphoma therapy(until off-trial therapy administration, for up to 10 years after randomization)
- Overall survival(every 6 months for up to 10 years after randomization)
- Best overall response (OR)(within 24 weeks)
- Adverse events, including laboratory abnormality assessments and vital signs(from inclusion until 30 days after treatment discontinuation)