NCT06936943招募中2 期
A Multicenter, Open-label, Uncontrolled Study to Evaluate the Efficacy and Safety of ONO-4538 in Patients With Richter's Transformation
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 14
- 试验地点
- 12
- 主要终点
- Objective response rate (ORR) (Centralized assessment)
研究概览
简要总结
Investigate the efficacy and safety of ONO-4538 in patients with Richter's transformation
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
- •Histological diagnosis of diffuse large B-cell lymphoma (DLBCL)-type or Hodgkin lymphoma(HL)-type Richter's transformation with a history of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
- •In the case of DLBCL-type Richter's transformation, refractory, intolerant or ineligible for treatment of DLBCL
- •Patients with measurable disease
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Expected to survive for 90 days or more
排除标准
- •Serious complications
- •Active multiple cancers
- •Active central nervous system (CNS) disease
- •History of allogeneic hematopoietic stem cell transplantation
研究组 & 干预措施
ONO-4538
Experimental
ONO-4538 480 mg solution administered intravenously every 4 weeks
干预措施: ONO-4538 (Drug)
结局指标
主要结局
Objective response rate (ORR) (Centralized assessment)
时间窗: up to 4 years
次要结局
- Objective response rate (ORR) (site investigator assessment)(up to 4 years)
- Overall survival (OS)(up to 4 years)
- Progression free survival (PFS)(up to 4 years)
- Disease control rate (DCR)(up to 4 years)
- Duration of response (DOR)(up to 4 years)
- Time to response (TTR)(up to 4 years)
- Best overall response (BOR)(up to 4 years)
- Change rate from baseline in the sum of diameters (SPD) of target lesions(up to 4 years)
- Best change rate from baseline in the sum of diameters (SPD) of target lesions(up to 4 years)
- Improvement rate of B symptom(up to 4 years)
- Safety (Adverse event)(Up to 30 days after the last dose)
研究者
研究点 (12)
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