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RECRUITING
NCT07059741
NA

Integrated Radiotherapy-optimized ASCT Sequential CAR-T Therapy for Patients With Relapsed and Refractory B-NHL

Sponsor: The First Affiliated Hospital of Soochow University

View on ClinicalTrials.gov

Summary

This study aims to investigate a novel therapeutic strategy of integrated radiotherapy before autologous stem cell transplantation (ASCT) sequential chimeric antigen receptor T-cell(CAR-T) therapy for patients with relapsed/refractory(R/R) aggressive B-cell non-Hodgkin lymphoma (B-NHL). By evaluating the efficacy and safety of this multimodal approach, we seek to provide a theoretical foundation and clinical data to optimize outcomes for relapsed/refractory aggressive B-NHL patients.

Official title: A Prospective Study of Integrated Radiotherapy-optimized ASCT Sequential CAR-T Therapy on the Efficacy and Safety of Patients With Relapsed and Refractory Aggressive B-cell Non-Hodgkin Lymphoma.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2024-12-10

Completion Date

2028-12-10

Last Updated

2025-07-11

Healthy Volunteers

No

Interventions

OTHER

integrated low-dose RT with reduced SEAM/TB conditioning before ASCT sequential CAR-T

1. RT regimen: localized low dose RT: 1-1.5Gy/fraction\*5fractions 2. Reduced dose SEAM regimen (CNS uninvolved): * Simustine 250mg/m2 d-6 orally * Cytarabine 200mg/m2 q12h d-5\~d-4 intravenous infusion * Etoposide 100mg/m2 q12h d-5\~d-4 intravenous infusion * Melphalan 140mg/m2 q12h d-3 intravenous infusion 3. TB regimen (CNS involvement): * Thiotepa 250mg/m2 qd, d-8\~d-6 intravenous infusion * Busulfan 0.8mg/kg q6h d-5\~d-3 intravenous infusion

OTHER

integrated high-dose RT with reduced SEAM/TB conditioning before ASCT sequential CAR-T

1. RT regimen: localized high dose RT: 3-6Gy/fraction\*5fractions 2. Reduced dose SEAM regimen (CNS uninvolved): * Simustine 250mg/m2 d-6 orally * Cytarabine 200mg/m2 q12h d-5\~d-4 intravenous infusion * Etoposide 100mg/m2 q12h d-5\~d-4 intravenous infusion * Melphalan 140mg/m2 q12h d-3 intravenous infusion 3. TB regimen (CNS involvement): * Thiotepa 250mg/m2 qd, d-8\~d-6 intravenous infusion * Busulfan 0.8mg/kg q6h d-5\~d-3 intravenous infusion

Locations (1)

the First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China