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临床试验/NCT00413036
NCT00413036已完成2 期

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

Celgene48 个研究点 分布在 7 个国家目标入组 217 人开始时间: 2006年6月最近更新:
适应症
干预措施
相关药物

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

lenalidomide

Experimental

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)

研究者

发起方
Celgene
申办方类型
Industry
责任方
Sponsor

研究点 (48)

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