A Study of Ultra-fraction Radiotherapy Bridging CART in R/R DLBCL
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking Union Medical College Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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 and anthracycline and either having failed autologous Hematopoietic stem cell transplantation (ASCT), or being ineligible for or not consenting to ASCT
Measurable disease at time of enrollment (the maximum diameter of cross section ≥1.5cm)
Disqualifiers
Prior radiation therapy within 1 year of infusion
Pregnant or nursing (lactating) women
Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion)
Previous solid tumor within 3 years, previous or concurrent hematological malignancy
Trial design
Design model
Single group
Treatments tested in this trial
ultra-fraction radiotherapy
Radiationthe R/R DLBCL patients would receive ultra-fraction radiotherapy as bridging therapy before the CD19 CART cell infusion
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: treatment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
3-month ORR
the overall response rate at 3 months after CAR-T cell infusion
Time frame
3 monthsSecondary outcomes
1
2-year PFS
the 2-year progression free survival time from CAR-T cell infusion
Time frame
2 years2
2-year OS
the 2-year overall survival time from CAR-T cell infusion
Time frame
2 years3
6-month ORR
the overall response rate at 6 months after CAR-T cell infusion
Time frame
6 months4
DOR
the duration of response time
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov