A Phase II, Multicenter, Single-Arm, Open-Label Study To Evaluate The Safety And Efficacy Of Single-Agent Lenalidomide (Revlimid®, CC-5013) in Subjects With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 217
- 试验地点
- 48
- 主要终点
- Participants Categorized by Best Response as Determined by Central Review
研究概览
简要总结
Subjects who qualify will receive oral lenalidomide daily on days 1-21 of every 28 day cycle. Treatment will continue until disease progression, or unacceptable adverse events develop
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
lenalidomide
25 mg oral lenalidomide once daily on Days 1-21 every 28 days
干预措施: lenalidomide (Drug)
结局指标
主要结局
Participants Categorized by Best Response as Determined by Central Review
时间窗: Up to 1459 days
Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definitions, refer to Cheson article. * Complete Response(CR): Complete disappearance of all detectable disease and disease-related symptoms if present before therapy; normalization of lab abnormalities assignable to NHL. If bone marrow involved before treatment, must be cleared on repeat biopsy. * Complete Response Unconfirmed(CRu): CR, with one of the following: 1)residual lymph node mass \>1.5 cm that has decreased by 75% in the sum of the product of the diameters(SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2)indeterminate bone marrow. * Partial Response(PR): \>50% decrease in 6 largest nodes or nodal masses. Nodes selected according to Cheson. * Stable Disease(SD): Less than PR, but not progressive disease. * Progressive Disease(PD): Appearance of new lesion during/end of therapy; \>=50% increase from lowest measurement in SPD.
次要结局
- Duration of Response as Determined by Central Review(Up to 1459 days)
- Time to Progression as Determined by Central Review(Up to 1459 days)
- Progression-free Survival as Determined by Central Review(Up to 1459 days)
- Proportion of Participants Who Experienced Stable Disease or Better as Determined by Central Review(Up to 1459 days)
