EUCTR2015-003168-35-IT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 with relapsed/ refractory extranodal mucosa-associated lymphoid tissue (MALT) lymphoma (CLEO Study) - A study with the aim to evaluate the antitumor activity of a new association of oral drugs, lenalido
IELSG - INTERNATIONAL EXTRANODAL LYMPHOMA STUDY GROUP0 个研究点目标入组 68 人开始时间: 2022年1月20日最近更新:
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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
- •- Adequate cardiac, renal and liver function tests (LVEF > 40%, serum creatinine < 2.5 mg/dl, ALAT or ASAT < 2.5 x upper limit of normal range, alkaline phosphatase < 2.5 x upper limit of normal range, serum bilirubin < 2.0 mg/dl)
- •- 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
- •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 34
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 34
排除标准
- •- Lymphoma histology other than MALT lymphoma or MALT lymphoma with a diffuse large cell lymphoma (high gradelymphoma”) - component
- •- 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
- •- 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
- •- Presence of active opportunistic infections
- •- Pregnancy or lactation
- •- Uncontrolled diabetes mellitus
- •- Pre-existing thromboembolic conditions at study entry
研究者
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