Phase II Study of Glofitamab, Poseltinib and Lenalidomide in Patients with Relapsed/refractory Diffuse Large B Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Efficacy evaluation of Gofitamab, Poseltinib, and Lenalidomide using endpoints
研究概览
简要总结
Prospective, open-ended, single-arm, multicenter Phase II clinical trial. To evaluate the efficacy of Glofitamab, Poseltinib, and Lenalidomide combination therapy in patients with relapsed/refractory diffuse large B-cell lymphoma.
详细描述
For outpatients or inpatients who meet the criteria for subject selection, the study is conducted with patients who have given a sufficient explanation of the study and who voluntarily consented to participate in the study.
Patients enrolled in the study receive a combination therapy of glofitamab, poseltinib, and lenalidomide according to the criteria specified in the protocol.
This therapy is defined as one cycle of 3 weeks, and a total of 12 cycles is planned.
glofitamab is administered in steps. 2.5 mg on the 8th day of Cycle 1, 10 mg on the 15th day, 30 mg on the 1st day of Cycle 2, and then 30 mg intravenously on the 1st day of each cycle.
poseltinib is administered orally at 40 mg BID daily from Day 1 to Day 21 of each cycle, and lenalidomide is administered orally at 30 mg QD daily from Day 1 to Day 14 of each cycle.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment
total 2years. Glofitamab: Increase from 2.5mg for 8days in 1 cycle to 10mg for 15days. 2cycles 1day 30mg, 30 mg on the 1st day of every week thereafter. Poseltinib: 40mg/day bid orally, administered daily from the 1st to the 21st of every week.
Lenalidomide: 20mg/day bid orally, administered daily from the 1st to the 14st of every week.
干预措施: Glofitamab, Poseltinib, Lenalidomide (Drug)
结局指标
主要结局
Efficacy evaluation of Gofitamab, Poseltinib, and Lenalidomide using endpoints
时间窗: At the end of Cycle 2 (each cycle is 28 days)
Overall Response Rate according to Lugano criteria
次要结局
未报告次要终点
研究者
Sung-Soo Yoon
hematology oncology Professor
Seoul National University Hospital