Last updated: January 15, 2024
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Lymphoma
Lymphoma, B-cell
Cancer Treatment
Treatment
ultra-fraction radiotherapy
Clinical Study ID
NCT05514327
CART-1
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 andanthracycline and either having failed autologous Hematopoietic stem celltransplantation (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
Exclusion
Exclusion Criteria:
- Prior radiation therapy within 1 year of infusion
- Pregnant or nursing (lactating) women
- Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. bloodculture 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 oractive hepatitis C( HCV RNA positive );
- Other conditions that the investigator may exclude due to risks or other possibilities
Study Design
Total Participants: 20
Treatment Group(s): 1
Primary Treatment: ultra-fraction radiotherapy
Phase:
Study Start date:
September 01, 2022
Estimated Completion Date:
December 01, 2024
Connect with a study center
Peking Union Medical College Hospital
Beijing, Beijing 100730
ChinaActive - Recruiting
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