NCT01534949终止1 期
A Phase 1, Multicenter, Open-Label, Single-Arm Study to Evaluate the Initial Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of CT-P10 Given in Combination With Dexamethasone, Cytosine Arabinoside, and Cisplatin (DHAP) in Patients With Diffuse Large B-Cell Lymphoma as Second-Line Chemotherapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Celltrion
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- safety
研究概览
简要总结
This study is designed to provide initial evidence of safety, pharmacokinetics, pharmacodynamics, and efficacy to support the pivotal CT-P10 therapeutic equivalence trial.
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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has histologically proven DLBCL, which may represent de novo DLBCL or DLBCL arising from transformed follicular lymphoma or chronic lymphocytic leukemia.
- •Patient has relapsed or refractory CD20-positive disease following previous first-line systemic chemotherapy. Patients who have failed to achieve complete remission with previous chemotherapy are defined as refractory, and those who relapsed after an initial complete remission are classified as having relapsed. A biopsy must be performed to confirm diagnosis of relapsed disease. Tumor tissue within 6 months of Day 1 of Cycle 1 of study treatment will be used for the central review.
- •Patient has at least 1 measurable tumor mass (greater than 1.5 cm in the longest dimension, or 1.1 to 1.5 cm in the longest dimension, and greater than 1.0 cm in the shortest axis) that has not previously been irradiated or has grown since previous irradiation
排除标准
- •Patient has allergies or hypersensitivity to murine, chimeric, human, or humanized proteins.
- •Patient has had prior allogeneic or ASCT.
- •Patient has received any other anticancer therapy within 28 days before Day 1 of Cycle 1 of study treatment and more than 1 prior line of chemotherapy, with the exception of having received the last dose of rituximab within 6 months before Day 1 of Cycle 1 of study treatment if they have undergone prior treatment with rituximab.
结局指标
主要结局
safety
时间窗: after 6 weeks of treatment begin
Adverse events, including SAEs
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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