EUCTR2012-001768-31-IT进行中（未招募）不适用
ZENO-01 90Y ibritumomab tiuxetan in patients with extra-nodal marginal zone B-cell lymphoma of Mucosa associated lymphoid tissue (MALT Lymphoma) - ZENO-01
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI0 个研究点开始时间: 2012年8月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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 • ECOG performance status = 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: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
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
研究者
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