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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

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