NCT00384150终止3 期
A Phase III, Open-Label, Multicenter, Single-Arm, Retreatment Study of Galiximab in Combination With Rituximab for Subjects With Relapsed, Follicular Non-Hodgkin's Lymphoma Who Previously Responded on Study 114-NH-301
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Biogen
- 入组人数
- 16
- 主要终点
- Safety measures include: adverse event rates, clinical laboratory results, development of anti-galiximab and human anti-chimeric antibodies
研究概览
简要总结
This is a Phase III, multicenter, global, open-label, single-arm, retreatment study of an investigational drug called galiximab in combination with an approved drug called rituximab in subjects with relapsed or refractory, follicular NHL who demonstrated a response on Study 114-NH-301 with a time-to-progression >=6 months.
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
- •Demonstrated a response (CR, CRu, or PR) on Study 114-NH-301 (Galiximab in combination with Rituximab compared with Rituximab in combination with Placebo) and then relapsed or progressed with a TTP >=6 months. Relapsed disease is defined as documented disease progression using the International Workshop Response Criteria (IWRC).
- •Bidimensionally measurable disease with at least 1 lesion >=2.0 cm in a single dimension.
- •Acceptable hematologic, hepatic, and renal function.
排除标准
- •Any lymphoma therapy between Final Visit on Study 114-NH-301 and Study Day 1 of this retreatment study.
- •Chronic or intermittent corticosteroids for inflammatory or autoimmune disorders within 3 weeks prior to Study Day
- •Transfusion-dependent subjects.
- •Presence of central nervous system (CNS) lymphoma.
- •Histologic transformation.
- •Presence of pleural or peritoneal effusion with positive cytology for lymphoma.
- •Another primary malignancy requiring active treatment.
- •Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions that would compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.
- •New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to Study Day 1.
结局指标
主要结局
Safety measures include: adverse event rates, clinical laboratory results, development of anti-galiximab and human anti-chimeric antibodies
时间窗: Study period is approx. 2 years
次要结局
- Pharmacokinetics(Study period is approx. 2 years)
- To further characterize the efficacy profile of galiximab in combination with rituximab(Study period is approx. 2 years)
研究者
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