Diffuse Large B Cell LymphomaCAR-TRadiotherapyBridging Therapy
Investigational drug(s) / intervention(s)
ultra-fraction radiotherapy
ultra-fraction radiotherapy: the R/R DLBCL patients would receive ultra-fraction radiotherapy as bridging therapy before the CD19 CART cell infusion
Study summary
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
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Over than 18 years old
2. Histologically confirmed DLBCL(by central pathology review before enrolment)
3. 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
4. Measurable disease at time of enrollment (the maximum diameter of cross section ≥1.5cm)
5. Life expectancy ≥12 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 ≤ 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
Primary outcome measure(s)
3-month ORR — 3 months the overall response rate at 3 months after CAR-T cell infusion
Trial sites (1)
Facility
City
Region
Status
Peking Union Medical College Hospital
Beijing
Beijing Municipality
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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