Phase II Study of Axicabtagene Ciloleucel Combined With Radiation Therapy for Relapsed or Refractory Follicular Lymphoma

What this Trial Is About

Researchers are evaluating the safety of a drug called axicabtagene ciloleucel combined with radiation therapy in patients with relapsed or refractory follicular lymphoma. This phase II study focuses on understanding the risk of serious side effects such as grade 3 or higher cytokine release syndrome within 30 days after the CAR T-cell infusion. Secondary goals include measuring response rates, survival outcomes, and exploring how tumor burden and immune cell profiles may affect treatment response. Participants will undergo a procedure to collect their white blood cells, which are used to create the axicabtagene ciloleucel treatment. Before receiving the CAR T-cell infusion, patients will have radiation therapy followed by conditioning chemotherapy. The treatment involves one infusion of axicabtagene ciloleucel administered through a vein. Additional medications such as cyclophosphamide, fludarabine phosphate, prednisone, diphenhydramine, and acetaminophen are also given intravenously as part of the treatment process. During the study, participants will be closely monitored for adverse events, with evaluations lasting about one year after treatment. Researchers will perform imaging scans to measure tumor lesions and collect blood samples to assess immune responses. The main focus is on tracking side effects, treatment effectiveness, and survival, while ensuring patient safety with regular health assessments throughout the study period.

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