NCT00048555已完成1 期
A Phase I/II Trial of IDEC-114 (Anti-CD80 Monoclonal Antibody) in Combination With Rituxan® for Patients With Relapsed or Refractory, Follicular Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To characterize the safety profile and to define the dose of galiximab to be used for the Phase II portion of the study
研究概览
简要总结
To determine what side effects and what clinical effect, if any, the administration of this investigational product, IDEC-114 in combination with Rituxan® [Rituxan® as a single agent is approved by the United States Food and Drug Administration (FDA) to treat patients with relapsed or refractory follicular NHL], has in this patient population.
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
- •Signed IRB-approved informed consent
- •Greater than or equal to 18 years of age
- •Proof of follicular lymphoma
- •Progressive disease requiring treatment after at least 1 prior standard therapy
- •Acceptable hematologic status, liver function, and renal function
- •Patients of reproductive potential must agree to follow accepted birth control methods during treatment and for 3 months after completion of treatment
排除标准
- •No response to prior Rituxan® or Rituxan®-containing regimen
- •Presence of CLL or CNS lymphoma
- •Known history of HIV infection or AIDS
- •Prior diagnosis of aggressive NHL or mantle-cell lymphoma
- •Serious nonmalignant disease
- •Pregnant or currently breast feeding
研究组 & 干预措施
1
Experimental
干预措施: IDEC-114 (Drug)
结局指标
主要结局
To characterize the safety profile and to define the dose of galiximab to be used for the Phase II portion of the study
时间窗: March 2010
次要结局
- To evaluate PK(March 2010)
- To evaluate efficacy(March 2010)
- To monitor for the presence of human anti galiximab antibody and human antichimeric antibody formation(March 2010)
研究者
研究点 (1)
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