NCT05514327招募中不适用
the Safety and Efficacy of Ultra-fraction Radiotherapy Bridging CART Cell Therapy in Relapsed/Refractory Diffuse Large b Cell Lymphoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 3-month ORR
研究概览
简要总结
This is a single-arm single center study to prospectively evaluate the safety and efficacy of ultra-fraction radiotherapy bridging CAR-T therapy in relapsed/refractory diffuse large b cell lymphoma
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
- •Over than 18 years old
- •Histologically confirmed DLBCL(by central pathology review before enrolment)
- •Relapsed or refractory disease after ≥2 lines of chemotherapy including rituximab and anthracycline and either having failed autologous Hematopoietic stem cell transplantation (ASCT), or being ineligible for or not consenting to ASCT
- •Measurable disease at time of enrollment (the maximum diameter of cross section ≥1.5cm)
- •Life expectancy ≥12 weeks
- •Able to receive radiotherapy evaluated by specialist
排除标准
- •Prior radiation therapy within 1 year of infusion
- •Pregnant or nursing (lactating) women
- •Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion)
- •Previous solid tumor within 3 years, previous or concurrent hematological malignancy
- •Severe organ dysfunction: left ventricle ejection fraction (LVEF) <40%; DLCO <40%; estimated glomerular filtration rate (eGFR)<30mL/min/1.73 m2; total bilirubin >3 ULN
- •HIV positive patients, active replication of or prior infection with hepatitis B or active hepatitis C( HCV RNA positive );
- •Other conditions that the investigator may exclude due to risks or other possibilities
结局指标
主要结局
3-month ORR
时间窗: 3 months
the overall response rate at 3 months after CAR-T cell infusion
次要结局
- 2-year PFS(2 years)
- DOR(2 years)
- the rate of severe side effects(2 years)
- 2-year OS(2 years)
- 6-month ORR(6 months)
- relapse rate(2 years)
研究者
Ruanjing
Docter
Peking Union Medical College Hospital
研究点 (1)
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