NCT00063713已完成2 期
A Phase 2 Study of VELCADE in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 35
研究概览
简要总结
The purpose of this study is to find out whether treatment with VELCADE will increase the time it takes for lymphoma to get worse.
详细描述
VELCADE is approved in multiple myeloma for patients who have received two prior therapies and their disease came back or got worse while on their second therapy. VELCADE is currently being studied in other types of cancers.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Confirmed diagnosis of mantle cell lymphoma
- •Documented relapse or progressive disease following 1 or 2 prior lines of anti-cancer therapy. At least one of those regimens must have included an anthracycline or mitoxantrone. Relapsed or progressive disease, since last therapy must be documented by new lesions or objective evidence of the progression of existing lesions.
- •At least 1 measurable or evaluable site of disease
- •Voluntary consent
排除标准
- •Previous treatment with VELCADE
- •Any experimental or anti-cancer therapy within 3 weeks before the first dose of study drug
- •Radiation therapy within 3 weeks before the first dose of study drug
- •Major surgery with 2 weeks before the first dose of study drug
- •Rituximab, Campath, or other unconjugated therapeutic antibody within 4 weeks before the first dose of study drug
- •Radioimmunotherapy or other toxin immunoconjugates such as Zevalin or Bexxar within 10 weeks before the first dose of study drug
- •History of allergic reactions to boron or mannitol compounds
- •Diagnosed or treated for another malignancy other than mantle cell lymphoma with 5 years before the first dose of study drug
- •Active systemic infection requiring treatment
- •Women patients must not be pregnant or breast-feeding, confirmed through pregnancy test obtained during screening (this test is not required for women who are post-menopausal or surgically sterile)
- •Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- •Concurrent treatment with another investigational drug or participation in non-treatment studies is not allowed if it interferes with participation in this clinical study
研究者
研究点 (35)
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