Master Protocol for Mantle Cell Lymphoma A Multicenter Phase II Trial Testing Everolimus (RAD001) for the Treatment of Patients With Relapsed or Therapy Resistant Mantle Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 21
- 主要终点
- Evaluation of the efficacy and tolerability of everolimus
研究概览
简要总结
RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well everolimus works in treating patients with relapsed or refractory mantle cell lymphoma.
详细描述
OBJECTIVES:
Primary
- Evaluation of the efficacy and tolerability of everolimus in patients with relapsed or therapy-resistant mantle cell lymphoma.
Secondary
- Evaluation of the efficacy of everolimus to induce molecular remission in patients treated with this regimen.
- Investigation of immunoglobulin heavy chain variable gene somatic hypermutations (Ig-V_H) in classical mantle cell lymphoma as compared to blastoid mantle cell lymphoma, in particular in regard to their frequency, mutation distribution pattern (antigen selected vs. at random), and the individually involved Ig-V_H families.
- Evaluation of a putative impact of Ig-V_H on clinical outcome.
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 —（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
Everolimus
Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: everolimus (Drug)
Everolimus
Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: molecular response by PCR (Genetic)
结局指标
主要结局
Evaluation of the efficacy and tolerability of everolimus
时间窗: Until treatment ends
次要结局
- Evaluation of the efficacy of everolimus to induce molecular remission in patients treated with this regimen.(Until treament ends)
- Evaluation of a putative impact of Ig-V_H on clinical outcome.(Until treatment ends)
- Investigation of immunoglobulin heavy chain variable gene somatic hypermutations(Until treatment ends)