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A Study of Ultra-fraction Radiotherapy Bridging CART in R/R DLBCL

RecruitingNAAges 18 Years - anyAllPeking Union Medical College Hospital
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In plain words

What the trial is, and whether it could suit you

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

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Over than 18 years old 2. Histologically confirmed DLBCL(by central pathology review before enrolment) 3. Relapsed or refractory disease after โ‰ฅ2 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 4. Measurable disease at time of enrollment (the maximum diameter of cross section โ‰ฅ1.5cm) 5. Life expectancy โ‰ฅ12 weeks 6. Able to receive radiotherapy evaluated by specialist Exclusion Criteria: 1. Prior radiation therapy within 1 year of infusion 2. Pregnant or nursing (lactating) women 3. Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive โ‰ค 72 hours prior to infusion) 4. Previous solid tumor within 3 years, previous or concurrent hematological malignancy 5. 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 6. HIV positive patients, active replication of or prior infection with hepatitis B or active hepatitis C( HCV RNA positive ); 7. Other conditions that the investigator may exclude due to risks or other possibilities
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What it tests

  • ultra-fraction radiotherapy
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Where

1 site
Peking Union Medical College Hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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