EUCTR2011-003657-26-CZ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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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:
- •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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