EUCTR2011-003657-26-IT进行中（未招募）1 期
An open label non-randomized phase 2 study evaluating SAR3419, an anti-CD19 antibody – maytansine conjugate, administered as single agent by intravenous infusion to patients with relapsed or refractory CD19+ diffuse large B cell lymphoma
SANOFI- AVENTIS RECHERCHE ET DÉVELOPPEMENT0 个研究点目标入组 55 人开始时间: 2011年12月28日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 55
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
- •Histological diagnosis of Diffuse Large B Cell Lymphoma (de novo or transformed) based on recent (less than 3 months) or new biopsy, expressing CD19 by immunohistochemistry or flow cytometry analysis (at least or more than 30% positivity). • At least 1 and not more than 2 prior specific therapeutic regimens, one of which should have included rituximab • Relapsed disease after standard 1st line therapy for aggressive lymphoma - not eligible for high dose chemotherapy with stem cell support. Relapsed or refractory disease after two lines of therapy one of which could have included Autologous Stem Cell Transplant (ASCT). Relapsed disease is defined as progression after a disease free interval of at least 6 months after completion of last therapy. Refractory is defined as progression of disease during prior therapy or within 6 months from its completion. • Available paraffin-embedded tissue should have been collected no longer than 3 months prior to first administration of SAR3419. Cryo-preserved tissue cannot be used. If archival material is not available, a Fine Needle Aspiration (FNA) must be obtained. • Signed 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 22
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 33
排除标准
- •Primary refractory patients • Patients with primary mediastinal DLBCL
研究者
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