EUCTR2020-003152-33-AT进行中（未招募）1 期
A phase II trial of long-term intravenous treatment with bi-weekly Azithromycin in patients with gastric lymphoma of the mucosa associated lymphoid tissue (MALT-lymphoma)
Med. Univ. Wien0 个研究点目标入组 46 人开始时间: 2020年7月7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
- 46
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 confirmed gastric MALT lymphoma with measurable disease (stage I – IV)
- •• Localized disease: First or greater relapse after surgery, radiation, chemotherapy or HP-eradication (patients judged refractory to HP-eradication by a minimum follow-up of 12 months after successful HP-eradication in case of HP-positive gastric lymphoma) or refractoriness/persistence to the said measures.
- •HP-negative patients or patients initially diagnosed with disseminated diserase are directly eligible and no initial attempt with antibiotics is considered in daily practice, as efficacy is low.
- •Age = 18 years
- •Life expectancy of at least 3 months
- •Able to tolerate therapy, and have adequate hematological, renal and liver function:
- •- red blood cell and/or platelet transfusions, ANC (absolute neutrophil count (segmented + bands) >1.0 x 109/L; platelets >50 x 109/L
- •- serum-creatinine < 2.0 times upper normal limit
- •- total bilirubin < 1.5 times upper normal limit (unless due to lymphoma involvement of liver or a known history of Gilbert’s disease); ALT < 2.5 times upper normal limit (unless due to disease involvement of liver); alkaline phosphatase < 2.5 times upper normal limit (unless due to disease involvement of the liver or bone marrow)
- •ECOG-PS 1 or 2
- •Capability 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 23
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 23
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 study treatment
- •History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 3 years
- •Major surgery, other than diagnostic surgery, within the last 4 weeks
- •Evidence of CNS 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
- •Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to study enrollment, congestive heart failure (NYHA III-IV), arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities, and long QT syndrome (QTc interval >450 ms).
- •Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment
- •Patients with active opportunistic infections
- •Known HIV infection
- •Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test at screening, pregnancy testing must be performed within 7 days before first administration of IMP. Approved methods of birth control must be used
- •Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy. Adequate contraception defined as hormonal birth control, intrauterine device, double barrier method or total abstinence.
- •Male subjects unable or unwilling to use adequate contraception methods.
- •Concurrent medication with ergotamine, theophylline or digitalis.
- •Patients who are hypersensitive to IMP (Azithromycin) or other Macrolide antibiotics.
研究者
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