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Trial Title:
A Study of Ultra-fraction Radiotherapy Bridging CART in R/R DLBCL
NCT ID:
NCT05514327
Condition:
Diffuse Large B Cell Lymphoma
CAR-T
Radiotherapy
Bridging Therapy
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
ultra-fraction radiotherapy
Description:
the R/R DLBCL patients would receive ultra-fraction radiotherapy as bridging therapy
before the CD19 CART cell infusion
Arm group label:
treatment group
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
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Zhang
Email:
zhangwei3840@126.com
Start date:
September 1, 2022
Completion date:
December 1, 2024
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05514327