Follicular Lymphoma Clinical Trial
Official title:
A Phase II Study of Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor (CAR) Tcell Therapy, in Combination With Radiotherapy (RT) in Relapsed/Refractory Follicular Lymphoma
To learn about the safety of a drug called axicabtagene ciloleucel given in combination with radiation therapy to patients with relapsed/refractory FL.
Primary Objectives: -The primary objective of this study is to determine the safety of standard of care axicabtagene ciloleucel with bridging radiotherapy (RT) in patients with relapsed/refractory follicular lymphoma, as assessed by the incidence of grade 3 or higher cytokine release syndrome (CRS) within 30 days after chimeric antigen receptor (CAR) T-cell infusion. Secondary Objectives: - Establish the rates of CRS and ICANS in patients treated with CAR T-cell therapy and radiation - Determine complete response rate (CR) at approximately 1 month post CAR T-cell ---therapy - Determine the overall response rate (ORR) - Determine the duration of response (DOR) - Determine progression free survival (PFS) - Determine overall survival (OS) Exploratory Objectives: -Assess the impact of tumor burden as measured by metabolic tumor volume and total lesion glycolysis on PET/CT on response following CAR T-cell infusion ;
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