jRCT2071250005招募中不适用
ONO-4538-131: A multicenter, open-label, uncontrolled study to evaluate the efficacy and safety of ONO-4538 in patients with Richter's transformation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 14
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •1.Patients with diffuse large B-cell lymphoma (DLBCL)-type or Hodgkin lymphoma(HL)-type Richter's transformation
- •2.In the case of DLBCL-type Richter's transformation, patients who are refractory, intolerant or ineligible for treatment of DLBCL
- •3.Petients with measurable disease
- •4.Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •5.Patients expected to survive for 90 days or more
排除标准
- •1.Patient with serious complications
- •2.Patients with active multiple cancers
- •3.Patients with active central nervous system (CNS) disease
- •4.Patients with history of allogeneic hematopoietic stem cell transplantation
结局指标
主要结局
-
Objective response rate (ORR) (Centralized assessment)
次要结局
- Objective response rate (ORR)
- Safety
研究者
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