the Safety and Efficacy of Ultra-fraction Radiotherapy Bridging CART Cell Therapy in Relapsed/Refractory Diffuse Large b Cell Lymphoma

Peking Union Medical College Hospital1 个研究点分布在 1 个国家目标入组 20 人2022年9月1日

适应症Diffuse Large B Cell Lymphoma CAR-T Radiotherapy Bridging Therapy

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Diffuse Large B Cell Lymphoma
发起方: Peking Union Medical College Hospital
入组人数: 20
试验地点: 1
主要终点: 3-month ORR
状态: 招募中
最后更新: 上个月

概览研究者入排标准结局指标研究点相似试验

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

注册库

clinicaltrials.gov

开始日期

2022年9月1日

结束日期

2028年12月1日

最后更新

上个月

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Peking Union Medical College Hospital

责任方

Principal Investigator

主要研究者

Ruanjing

Docter

Peking Union Medical College Hospital

入排标准

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