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临床试验/NCT01133743
NCT01133743已完成2 期

An Open-Label Phase 2 Study of Lenalidomide (Revlimid) in Combination With Oral Dexamethasone in the Treatment of Previously Untreated, Symptomatic Patients With Chronic Lymphocytic Leukemia (CLL)

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2010年5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
入组人数
31
试验地点
1
主要终点
Response rate

研究概览

简要总结

This is a phase II, non-randomized, single institution study in symptomatic, previously untreated CLL patients. All patients will receive the study drug, lenalidomide, given PO daily continuously on a 28 day cycle at the starting dose level of either 2.5 mgs or 5 mgs with dose escalations to a target dose of 25mg daily. Oral dexamethasone at 12 mg PO daily will be administered on days 1-7, 14 and 21 of each cycle. Patients will be treated with lenalidomide and dexamethasone to 2 cycles past CR or to a maximum of 18 cycles, each cycle of 28 days duration. Primary endpoint is response.

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 and Dexamethasone

Experimental

Lenalidomide target dose of 25 mg PO OD continuously (28-day cycle) using an initial dose escalation period. Oral dexamethasone 12 mg daily on days 1-7, 14 and 21 of each cycle.

干预措施: Lenalidomide and Dexamethasone (Drug)

结局指标

主要结局

Response rate

时间窗: 18 cycles (each cycle is of 28 days)

次要结局

  • Time to progression(Participants will be followed until death)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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