NCT00972842终止1 期
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)
Arbeitsgemeinschaft medikamentoese Tumortherapie10 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2009年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 10
- 主要终点
- The primary objective of this study is to determine the maximum tolerated dose (MTD) of a Lenalidomide, Vorinostat, and Dexamethasone combination regimen in terms of occurrence of dose-limiting toxicities (DLT) at any dose level.
研究概览
简要总结
A standard therapy is neither established in first-line patients nor in relapsed patients with PTCL, and there is still an unmet medical need to identify novel efficacious and safe therapy regimens.
The aim of this study is to evaluate the potential of a Lenalidomide plus Vorinostat and Dexamethasone combination therapy as an effective and safe therapeutic regimen, in the treatment of relapsed PTCL following failure of prior regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patients with relapsed PTCL according to WHO criteria who have received max. two previous treatments for PTCL
- •Age ≥ 18 years.
- •Adequate bone marrow function i.e. absolute neutrophile count of > 1000/µl and thrombocytes > 75,000/µl.
- •Alkaline phosphatase and transaminases ≤ 2,5 x upper limit of normal (ULN)
- •Total bilirubin ≤ 2,5 x ULN
- •Creatinine clearance ≥ 50 ml/min
- •Female subjects of childbearing potential† must: Understand that the study medication could have an expected teratogenic risk and agree to use, and be able to comply with, effective contraception and agree to have a medically supervised pregnancy test
- •Male subjects must agree to use condoms and agree not to donate semen
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
- •Prior treatment with a HDAC inhibitor
- •Prior treatment with Lenalidomide (patients previously treated with Thalidomide may be enrolled)
- •Known history of Deep Vein Thrombosis (DVT) and/ or pulmonary embolism (PE)
结局指标
主要结局
The primary objective of this study is to determine the maximum tolerated dose (MTD) of a Lenalidomide, Vorinostat, and Dexamethasone combination regimen in terms of occurrence of dose-limiting toxicities (DLT) at any dose level.
时间窗: 6 months
次要结局
- Remission rate of a combination therapy with Lenalidomide, Vorinostat, and Dexamethasone in a treatment refractory or relapsed population, defined as the percentage of patients achieving a complete response (CR) or partial response (PR)(6 months)
研究者
研究点 (10)
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