EUCTR2008-006919-20-AT进行中（未招募）不适用
Phase I/II Trial of Lenalidomide in Combination with Vorinostat and Dexamethasone as Therapy in Relapsed or Refractory Patients with Peripheral T-Cell Non-Hodgkin’s Lymphoma (PTCL) - LenVoDex
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Patients with relapsed PTCL according to WHO criteria who have received max. two previous treatments for PTCL or patients with primary refractory PTCL after one previus treatment
- •Age = 18 years.
- •Adequate bone marrow function
- •Alkaline phosphatase and transaminases = 2,5 x ULN
- •Total bilirubin = 2,5 x ULN
- •Creatinine clearance = 50 ml/min
- •Life expectancy > 6 months
- •ECOG performance status 0-2
- •CIRS score = 6
- •Ability and willingness to adhere to antithrombotic prophylaxis
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Prior history of malignancies, other than PTCL, unless the subject has been free of the disease for = 3 years
- •Prior allogeneic bone marrow transplant or plans to undergo autologous/ allogeneic bone marrow transplant within 4 weeks of the initiation of vorinostat administration
- •Pregnant or lactating women
- •Any of the following concomitant conditions: clinically manifest heart failure NYHA stages III and IV, myocardial infarction within the last six months, chronic lung disease with severe hypoxemia, severe diabetes mellitus that cannot be stabilized, severe arterial hypertension that cannot be stabilized
- •Known history of Deep Vein Thrombosis and/ or pulmonary embolism
- •Active infection or severe infection (WHO 4th degree) within the last three months before inclusion in the study, seropositivity for HIV, HBV or HCV
研究者
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