EUCTR2011-003495-36-IT进行中（未招募）1 期
A multicenter pilot phase II study for the preliminary evaluation of feasibility, activity and safety of the administration of Bendamustine and Ofatumumab in combination in marginal zone B-cell lymphomas (MZL)
SENDO TECH0 个研究点目标入组 15 人开始时间: 2012年3月12日最近更新:
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
- 15
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
- •1. Age > 18 2. Histologically proven diagnosis of marginal zone B-cell lymphoma relapsing/refractory following at least 1 prior systemic treatment (chemotherapy and/or monoclonal antibodies) 3. Any stage (Ann Arbor I-IV) 3. Life expectancy of at least 6 months and ECOG performance status 0-1 4. No evidence of histological transformation to diffuse large cells lymphoma 5. Adeguate bone marrow function, renal function or liver function 6. Signed 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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrollment 2. Treatment with anti-CD20 monoclonal antibody or alemtuzumab within 8 weeks prior to the enrollment 3. Treatment with corticosteroids during the last 4 weeks 4.Other past or current malignancy 5. Previous organ transplantation 6.Clinically significant cardiac or pulmonary disease 7.History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequele 8. Concomitant infectious diseases, HIV positive, Hepatitis B or C positive.
研究者
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