A Phase II Study of Bortezomib and Gemcitabine in Patients With Relapsed Mantle Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 11
- 主要终点
- Objective tumor response (overall response rate with 95% confidence interval)
研究概览
简要总结
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may help gemcitabine work better by making cancer cells more sensitive to the drug.
PURPOSE: This phase II trial is studying how well giving bortezomib together with gemcitabine works in treating patients with relapsed mantle cell lymphoma.
详细描述
OBJECTIVES:
- Determine the efficacy (response rate) of bortezomib and gemcitabine hydrochloride in patients with relapsed mantle cell lymphoma.
- Determine the toxicity of this regimen in these patients.
- Determine the time to progression and duration of response in patients treated with this regimen.
OUTLINE: This is a nonrandomized, multicenter study.
Patients receive bortezomib IV on days 1, 4, 8, and 11 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter until relapse/progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 120 Years（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
Bortezomib + Gemcitabine
干预措施: bortezomib (Drug)
Bortezomib + Gemcitabine
干预措施: gemcitabine hydrochloride (Drug)
结局指标
主要结局
Objective tumor response (overall response rate with 95% confidence interval)
时间窗: each cycle
Time to progression at median time
时间窗: each cycle and every 3 months after treatment
Duration of response (median and range)
时间窗: each cycle and every 3 months after treatment
Rate of stable disease and progressive disease
时间窗: each cycle and every 3 months after treatment
次要结局
未报告次要终点