EUCTR2015-003168-35-AT进行中（未招募）1 期
A phase II trial addressing feasibility and activity of clarithromycin +lenalidomide combination: a full oral treatment for patients withrelapsed/refractory extranodal marginal zone lymphoma - CLEO Trial / IELSG-40
IELSG International Extranodale Lymphoma Study Group; Instituto Oncologico della Svizzera Italiana,0 个研究点目标入组 68 人开始时间: 2016年8月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 68
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
- •· Histologically verified diagnosis of MALT lymphoma arising at any extranodal site
- •· Disease refractory to or in first or greater relapse after prior radiotherapy and/or chemotherapy and/or immunotherapy
- •· Measurable or non-measurable lesions where the response is nevertheless evaluable by non-imaging means (e.g., gastric or bone marrow infiltrations)
- •· Ann Arbor Stage I-IV
- •· ECOG performance status of 0, 1 or 2
- •· Age = 18 years
- •· Life expectancy of at least 3 months
- •· Adequate haematological status
- •· Adequate cardiac, renal and liver function tests
- •· Patient must be willing and able to comply with the protocol for the entire study duration
- •· Female patients of childbearing potential must agree to use, and be able to comply with, effective contraception and agree to have medically supervised pregnancy tests prior to starting the study treatment and during therapy
- •· Male patients must agree to always use a condom during any sexual contact with females of reproductive potential and agree to not donate
- •sperm while taking lenalidomide
- •· Patient must agree to abstain from donating blood while taking study drug therapy
- •· Patient must agree not to share study medication with another person and to return all unused study drug to the investigator
- •· Patient must be willing and able to comply with the protocol
- •· Patient must be capable of understanding the purpose of the study and have given written informed consent
- •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 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •· Lymphoma histology other than MALT lymphoma or MALT lymphoma with a diffuse large cell lymphoma (high grade lymphoma”) -
- •· Use of any investigational agent within 28 days prior to initiation of treatment
- •· History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix within
- •the last 5 years unless in complete remission since at least 3 years
- •· Dependency on red blood cell and/or platelet transfusions
- •· Evidence of central nervous system involvement
- •· A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs
- •· Severe peripheral polyneuropathy
- •· Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well
- •controlled with medication) or myocardial infarction within the last 6 months and/or long QT-syndrome
- •· HIV seropositivity
- •· Presence of active opportunistic infections
- •· Pregnancy or lactation
- •· Uncontrolled diabetes mellitus
- •· Pre-existing thromboembolic conditions at study entry
- •· Known hypersensitivity to thalidomide or lenalidomide or macrolide
研究者
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