NCT03031483已完成2 期
A Phase II Trial Addressing Feasibility and Activity of Clarithromycin + Lenalidomide Combination: a Full Oral Treatment for Patients With Relapsed/Refractory Extranodal Marginal Zone Lymphoma
International Extranodal Lymphoma Study Group (IELSG)10 个研究点 分布在 3 个国家目标入组 44 人开始时间: 2017年4月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 10
- 主要终点
- Tumor response assessment
研究概览
简要总结
Patients with lymphoid tissue lymphoma mucosa-associated (MALT) for which the standard treatments with radiotherapy, chemotherapy and / or immunotherapy show lack of efficacy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open Label
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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: ANC (absolute neutrophil count [segmented + bands]) ≥1.0 x 109/L, platelet count ≥ 75 x 109/L , haemoglobin ≥8 g/dL.
- •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)
- •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
排除标准
- •Lymphoma histology other than MALT lymphoma or MALT lymphoma with a diffuse large cell lymphoma ("high grade lymphoma") component
- •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
- •HBsAg positivity
- •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 antibiotics
- •Presence of any contraindication reported on the Summary of Product Characteristics (SmPC) of Clarithromycin
- •Hypersensitivity to any active principle and/or any excipient according to the contraindications reported in the SmPC of clarithromycin and in the Investigator's Brochure (IB) of lenalidomide
研究组 & 干预措施
Experimental: clarithromycin and lenalidomide
Experimental
CLARITHROMYCIN: daily orally administration in cycles of 28 days; 500mg film-coated tablets LENALIDOMIDE: every cycle of treatment lasts 28 days; daily orally administration is of 21 consecutive days with a week of rest. 20mg capsule hard. The maximum treatment duration is 12 months.
干预措施: clarithromycin and lenalidomide (Drug)
结局指标
主要结局
Tumor response assessment
时间窗: During the active treatment period after the 3rd cycles of both drugs administration
The primary outcome measure is tumour response assessed according to the Revised Response Criteria for Malignant Lymphoma, either clinically (including appropriate imaging procedures) or endoscopically and histologically (in patients affected by gastric lymphoma, according to the GELA scoring system).
次要结局
- Adverse Events assessments(During the active treatment period)
研究者
研究点 (10)
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