NCT00085696已完成2 期
A Phase 2 Study of VELCADE® (Bortezomib) With Rituximab in Subjects With Relapsed or Refractory Indolent B-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
- 66
- 试验地点
- 26
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of VELCADE when given in combination with rituximab in patients with Relapsed or Refractory Indolent B-Cell Lymphoma. This study will investigate if treatment with VELCADE and rituximab increases the time it takes your lymphoma to get worse.
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
- •Male or female subject 18 years or older
- •Diagnosis of B-cell lymphoma (CD20+) of
- •follicular lymphoma (grades 1, 2, and 3) or
- •marginal zone lymphoma (extranodal, nodal, and splenic)
- •Documented relapse or progression following prior anti-neoplastic treatment.
- •At least 1 measurable lymph node mass that is >1.5 cm.
- •No active CNS lymphoma
- •Voluntary consent
排除标准
- •Previous treatment with VELCADE
- •Any anti-neoplastic or experimental therapy within 3 weeks before the first dose of study drug.
- •Any treatment with nitrosoureas within 6 weeks before the first dose of study drug.
- •Treatment with Zevalin™ or Bexxar® within 10 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.
- •Radiation therapy within 3 weeks before the first dose of study drug.
- •Major surgery within 2 weeks before the first dose of study drug.
- •Peripheral neuropathy or neuropathic pain
- •History of allergic reaction attributable to compounds containing boron or mannitol
- •Known anaphylaxis or hypersensitivity to any component of rituximab
- •Diagnosed or treated for a selected malignancies other than NHL within 5 years.
- •Active systemic infection requiring treatment
- •Female subjects must not be pregnant, breast-feeding, or become pregnant during the course of the study.
- •Male subjects who do not agree to use an acceptable method of contraception for the duration of the study
- •Any serious medical or psychiatric illness likely to interfere with participation in this clinical study
- •Concurrent treatment with another investigational agent. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study.
研究者
研究点 (26)
Loading locations...
相似试验
已完成
2 期
A Phase II Study of VELCADE (Bortezomib) in Combination With Bendamustine and Rituximab in Subjects With Relapsed or Refractory Follicular LymphomaFollicular LymphomaNCT00636792Millennium Pharmaceuticals, Inc.73
已完成
2 期
VELCADE® Plus Rituximab in Non Hodgkin's Follicular LymphomaNon Hodgkin's Follicular LymphomaNCT01830465Gruppo Italiano Studio Linfomi45
已完成
2 期
Velcade (Bortezomib, PS-341) and Rituximab in Relapsed/Refractory Mantle Cell and Follicular Non-Hodgkin's LymphomaNon-Hodgkin's LymphomaMantle Cell LymphomaNCT00201877Ohio State University Comprehensive Cancer Center25
已完成
1 期
Bortezomib, Rituximab and Combination Chemotherapy in Treating Participants With Mantle Cell LymphomaMantle Cell LymphomaNCT00477412M.D. Anderson Cancer Center107
已完成
2 期
A Study to Evaluate Two Different Regimens of VELCADE in Combination With Dexamethasone, Thalidomide and Cyclophosphamide (VDT vs VDTC) in Newly Diagnosed Multiple MyelomaMultiple MyelomaNCT00531453Millennium Pharmaceuticals, Inc.98