Bridging Therapy, CAR-T, Diffuse Large B Cell Lymphoma, Radiotherapy
Conditions
Brief 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
Interventions
RADIATIONultra-fraction radiotherapy
the R/R DLBCL patients would receive ultra-fraction radiotherapy as bridging therapy before the CD19 CART cell infusion
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-month ORR | 3 months | the overall response rate at 3 months after CAR-T cell infusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 2-year PFS | 2 years | the 2-year progression free survival time from CAR-T cell infusion |
| 2-year OS | 2 years | the 2-year overall survival time from CAR-T cell infusion |
| 6-month ORR | 6 months | the overall response rate at 6 months after CAR-T cell infusion |
| DOR | 2 years | the duration of response time |
| relapse rate | 2 years | the cumulative rate of relapse |
| the rate of severe side effects | 2 years | the rate of severe side effects (CTCAE≥ grade 3） |
Countries
China
Contacts
CONTACTJing Ruan, Docter
Outcome results
None listed