NCT01209130已完成1 期
An Open-Label, Multicenter, Phase I Trial of the Safety and Pharmacokinetics of Escalating Doses of DCDT2980S in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia And DCDT2980S in Combination With Rituximab in Patients With Relapsed or Refractory B-Cell Non Hodgkin's Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 91
- 主要终点
- Incidence and nature of dose-limiting toxicities (DLTs)
研究概览
简要总结
This is a Phase I, multicenter, open-label, dose-escalation study of DCDT2980S administered by intravenous (IV) infusion to patients with relapsed or refractory hematologic malignancies. In addition, at selected sites, DCDT2980S will be studied in combination with rituximab.
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
- •Life expectancy of at least 12 weeks
- •History of histologically-documented hematologic malignancy for which no effective standard therapy exists: indolent NHL (including Grades 1-3a FL; MZL [including splenic, nodal, and extra-nodal]; and SLL), Grade 3b FL, DLBCL, MCL, or CLL
- •Must have at least one bi-dimensionally measurable lesion
排除标准
- •Prior use of any monoclonal antibody or antibody-drug conjugate within 4 weeks prior to study treatment
- •Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other investigational anti-cancer agent within 2 weeks prior to of study treatment
- •Completion of autologous stem cell transplant within 100 days prior to study treatment
- •Prior allogeneic stem cell transplant
研究组 & 干预措施
A
Experimental
干预措施: DCDT2980S (Drug)
B
Experimental
干预措施: DCDT2980S (Drug)
B
Experimental
干预措施: rituximab (Drug)
结局指标
主要结局
Incidence and nature of dose-limiting toxicities (DLTs)
时间窗: Throughout study or until early discontinuation
次要结局
- Objective response, defined as a partial response (PR) or complete response (CR)(Throughout study or until early discontinuation)
研究者
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