EUCTR2007-004289-42-GR进行中（未招募）不适用
90Y ibritumomab tiuxetan (Zevalin®) in patients with extra-nodal marginal zone B-cell lymphoma of Mucosa associated lymphoid tissue (MALT Lymphoma) - ZENO
ational and Kapodistrian University of Athens0 个研究点目标入组 40 人开始时间: 2007年9月19日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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 proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any extra nodal site
- •Any stage (Ann Arbor I-IV)
- •Either de novo, or relapsed/refractory disease following local therapy (including surgery, radiotherapy, and antibiotics for Helicobacter pylori-positive gastric lymphoma) or prior chemotherapy regimen +/- anti-CD20 immunotherapy
- •No evidence of histologic transformation to a high grade lymphoma
- •Measurable or evaluable disease
- •For primary gastric localized Helicobacter pylori-positive disease at diagnosis: 1) persistent disease 1 year after documented Helicobacter pylori infection eradication and 2) clinical, endoscopic (or histologic) evidence of progression at any time after Helicobacter pylori infection eradication
- •Patient age > 18 years
- •performance status ECOG <2
- •life expectancy of at least 6 months
- •effective contraception in female pre-menopausal patients
- •No prior disease of neoplasm within 5 years, except cervical intra-epithelial neoplasia type-1(CIN1) or localized non melanomatous skin cancer
- •No prior chemotherapy, immunotherapy and radiotherapy in the last 6 weeks
- •No corticosteroids during the last 28 days unless prednisone chronically administered at a dose <20 mg/day for indications other than lymphoma or lymphoma-related symptoms
- •No evidence of clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months before study entry
- •No evidence of symptomatic central nervous system (CNS) disease
- •No impairment of bone marrow function (WBC >3,000/mm3, ANC >1,500/mm3, PLT >100,000/mm3)
- •No impairment of renal or liver function, unless due to lymphoma involvement
- •No known HIV infection, no active HBV and/or HCV infection and no evidence of active opportunistic infection
- •No pregnant or lactating status and appropriate contraceptive method in women of childbearing potential
- •Appropriate contraceptive method in men
- •No psychiatric illness precluding understanding concepts of the trial or signing informed consent
- •The patient has 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Prior autologous or allogeneic SCT or previous organ transplantation
- •>25% bone marrow infiltration
- •active auto-immune haemolytic anaemia
- •participation in another clinical trial during the last 4 weeks
- •renal insufficiency (creatinine > 2.0 mg/dl), not related to lymphoma
- •hepatic insufficiency (transaminase >3-fold of upper normal limit or
- •bilirubin > 2.0 mg/dl), not related to lymphoma
- •active infection (e.g. HBV, HCV, HIV)
- •concurrent disease which may hamper the per protocol therapy
- •severe psychiatric disease or cerebral dysfunction
- •women during lactation or pregnancy
研究者
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