NCT00435916已完成2 期
A Phase II Study of SGN-40 (Anti-huCD40 mAb) in Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Seagen Inc.
- 入组人数
- 46
- 试验地点
- 14
- 主要终点
- Objective response as assessed by CT and PET scans and revised response criteria for malignant lymphoma.
研究概览
简要总结
This is a Phase II, open-label, multidose trial of SGN-40 designed to estimate objective response rate and assess toxicity in patients with relapsed DLBCL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of DLBCL.
- •Received at least one combination chemotherapy regimen with rituximab, such as R-CHOP, R-ESHAP or equivalent.
- •Progression or relapse since most recent therapy.
- •At least one measurable lesion that is both greater than or equal to 2 cm by conventional CT or greater than or equal to 1.5 cm by spiral CT.
排除标准
- •Previous diagnosis or treatment for indolent lymphoma, leptomeningeal lymphoma, or central nervous system lymphoma.
- •Primary refractory disease.
- •Received an allogenic stem cell transplant.
研究组 & 干预措施
1
Experimental
干预措施: SGN-40 (Drug)
结局指标
主要结局
Objective response as assessed by CT and PET scans and revised response criteria for malignant lymphoma.
时间窗: Every 1 or 2 months
次要结局
- Adverse events, laboratory values, and anti-drug antibody immune responses.(Within 3 weeks of final infusion)
- Progression-free survival, disease-free survival, and overall survival.(Study duration)
- PK profile.(Within 3 weeks of final infusion)
研究者
研究点 (14)
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