NCT00655837已完成1 期
A Phase Ib Study of SGN-40 in Combination With Rituximab and Gemcitabine for the Treatment of Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Seagen Inc.
- 入组人数
- 33
- 试验地点
- 9
- 主要终点
- Determine the safety and adverse-event profile for combination therapy of SGN-40 with gemcitabine and rituximab.
研究概览
简要总结
The purpose of this study is to determine safety and tolerability of combination therapy of SGN-40 with gemcitabine and rituximab for the treatment of lymphoma. This study is also intended to estimate how well your disease responds to this treatment.
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
- •Have a histologic diagnosis of DLBCL, including transformed histology and follicular grade 3 disease.
- •Must have at least one site of biopsy-proven disease demonstrating both of the following: bidimensional measurable disease with the longest axis >= 1.5cm by radiographic imaging or positive FDG-PET scan at baseline.
- •Patients with DLBCL and who have either relapsed, refractory, or progressive disease following salvage therapy, OR relapsed, refractory, or progressive disease following initial therapy and be medically unfit to receive aggressive therapy.
- •Either fresh or archived tumor specimen must be available.
排除标准
- •Documented history within 6 months of registration of a cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms.
- •Patients who have received allogeneic stem cell transplant.
- •Patients with evidence of another invasive primary malignancy within the past three years other than non-melanoma skin cancer, cervical carcinoma in situ, in situ carcinoma of the breast, or fully resected prostate cancer with normal PSA within 8 weeks of registration.
- •Patients with any active systemic viral, bacterial, or fungal infection requiring intravenous anti-infectives within 4 weeks prior to first dose of study drug.
- •Patients with a history or clinical evidence of leptomeningeal or central nervous system (CNS) lymphoma.
研究组 & 干预措施
1
Experimental
干预措施: SGN-40 (Drug)
1
Experimental
干预措施: rituximab (Drug)
1
Experimental
干预措施: gemcitabine (Drug)
结局指标
主要结局
Determine the safety and adverse-event profile for combination therapy of SGN-40 with gemcitabine and rituximab.
时间窗: 10 months from registration of last patient
次要结局
- Estimate progression free survival, clinical response rates to treatment, and overall survival to determine efficacy.(Follow-up every 6 weeks after end of treatment.)
研究者
研究点 (9)
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