EUCTR2009-011020-65-NL进行中（未招募）不适用
A phase III study of lenalidomide maintenance after debulking with gemcitabine or liposomal doxorubicin +/- radiotherapy in patients with advanced cutaneous T-cell lymphoma not previously treated with intravenous chemotherapy.
European Organisation for Research and Treatment of Cancer0 个研究点目标入组 105 人开始时间: 2010年3月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 105
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Mycosis Fungoides, Stage IIB to IV or Sézary Syndrome.
- •- Partial or complete response to a specific debulking regimen consisting of either gemcitabine or liposomal doxorubicin no more than 6 weeks prior to randomization. It is acceptable for patients entering the study to have received local radiotherapy for symptom control during the debulking period.
- •- Fit for chemotherapy (adequate organ function, as reflected by creatinine clearance, liver function tests and hematopoietic indices).
- •- Patient informed consent.
- •- WHO Performance status 0-2.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Disease previously treated by intravenous chemotherapy (gemcitabine or caelyx
- •are allowed) used in the debulking regimen.
- •- Disease not appropriate for skin-directed therapy (per local institution standards)
- •- Contraindications to lenalidomide treatment
研究者
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