A Multicenter, Prospective, Observational Clinical Protocol for Chidamide in Combination With Rituximab and Lenalidomide (cR2) in Real-world Practice in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 169
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
A Multicenter, Prospective, Observational Clinical Protocol for Chidamide in Combination With Rituximab and Lenalidomide (cR2) in Real-world Practice in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
详细描述
This is a prospective, multicenter, observational investigator-initiated clinical study. The subjects were adults (18 years of age and older) diagnosed with relapsed/refractory diffuse large B-cell lymphoma who will begin cR2 therapy at the time of enrollment. Patients were required to complete a visit every 4 weeks, lasting 24 weeks from the first dosing of the study protocol. The first visit was considered an enrollment visit. The specific dosage of cR2 will be determined according to the standard clinical practice of the treating physician. Participation in the study did not affect treatment decisions. Patients who could not continue with the cR2 regimen would terminate the visit early and then withdraw from the study. According to the data collected from the experiment, the safety and effectiveness of the research scheme were analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •The decision of treating physicians to make cR2 regimen was not related to whether they participated in the study or not;
- •Age 18 and above, no gender limitation;
- •Patients with pathologically confirmed diffuse large B-cell lymphoma (DLBCL) who have relapsed or failed to respond to at least one systemic therapy;
- •Have at least one measurable lesion: any length of lymph node lesion ≥1.5cm or any length of extrinsic lesion > 1cm;
- •The serum pregnancy test of female subjects of childbearing age was negative;
- •Understand the test procedure and content, and sign the informed consent voluntarily.
排除标准
- •The decision of treating physicians to make cR2 regimen was not related to whether they participated in the study or not;
- •Age 18 and above, no gender limitation;
- •Patients with pathologically confirmed diffuse large B-cell lymphoma (DLBCL) who have relapsed or failed to respond to at least one systemic therapy;
- •Have at least one measurable lesion: any length of lymph node lesion ≥1.5cm or any length of extrinsic lesion > 1cm;
- •The serum pregnancy test of female subjects of childbearing age was negative;
- •Understand the test procedure and content, and sign the informed consent voluntarily.
研究组 & 干预措施
Chidamide in combination with rituximab and lenalidomide
Chidamide tablets: 20mg orally, twice a week (at least 3 days between doses); Rituximab injection: 375mg/m2 intravenously, once every 4 weeks (Q4w), on the first day of each cycle; Lenalidomide capsule: 25mg orally, once before going to bed every night, from day 1 to day 21 of each cycle
干预措施: Chidamide (Drug)
Chidamide in combination with rituximab and lenalidomide
Chidamide tablets: 20mg orally, twice a week (at least 3 days between doses); Rituximab injection: 375mg/m2 intravenously, once every 4 weeks (Q4w), on the first day of each cycle; Lenalidomide capsule: 25mg orally, once before going to bed every night, from day 1 to day 21 of each cycle
干预措施: Lenalidomide (Drug)
Chidamide in combination with rituximab and lenalidomide
Chidamide tablets: 20mg orally, twice a week (at least 3 days between doses); Rituximab injection: 375mg/m2 intravenously, once every 4 weeks (Q4w), on the first day of each cycle; Lenalidomide capsule: 25mg orally, once before going to bed every night, from day 1 to day 21 of each cycle
干预措施: Rituximab (Drug)
结局指标
主要结局
Objective response rate
时间窗: 30 months
Objective response rates assessed by the investigator
次要结局
- Adverse Events(30 months)