Weekly Bendamustine and Bortezomib Combination Therapy in Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma or B-CLL: A Single-Center Phase 2 Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Optimal Bendamustine Dosage for Further Studies
研究概览
简要总结
The purpose of this study is to determine whether the combination of bendamustine and bortezomib in patients with indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia is safe and tolerable.
详细描述
Bendamustin and bortezomib have been shown to be effective in the treatment of patients with indolent Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL). Both compounds appear not to be cross-resistant with prior therapy. Therefore, it is of interest to combine bendamustine and bortezomib in this patient population.
Preliminary results from patients with multiple myeloma showed that the combination of bendamustine and bortezomib is efficacious and well tolerated. However, there are so far no data on this combination in patients with NHL or CLL.
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
- •Symptomatic recurrent or refractory indolent NHL or B-CLL
- •Adequate organ and bone marrow function
- •Karnofsky greater than 50%
排除标准
- •Candidates for autologous stem cell transplantation
- •Secondary high grade lymphoma
- •Concurrent severe medical condition
研究组 & 干预措施
Bendamustine and Bortezomib
Combination Chemotherapy of Bendamustine and Bortezomib as described in the intervention section
干预措施: Bendamustine (Drug)
Bendamustine and Bortezomib
Combination Chemotherapy of Bendamustine and Bortezomib as described in the intervention section
干预措施: Bortezomib (Drug)
结局指标
主要结局
Optimal Bendamustine Dosage for Further Studies
时间窗: Three weeks after treatment termination
次要结局
未报告次要终点