A Phase 3 Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects with Relapsed/Refractory Follicular Lymphoma
Objective
Primary Objective: To determine if axicabtagene ciloleucel is superior to standard of care therapy (SOCT), as measured by progression-free survival (PFS) per a blinded independent radiologic review committee (hereafter referred to as blinded central assessment) in subjects with r/r FL.
Secondary Objective: To further characterize the efficacy and safety profile and patient reported outcomes associated with axicabtagene ciloleucel versus SOCT
Exploratory Objective: To characterize the pharmacokinetic profile of axicabtagene ciloleucel in subjects with r/r high-risk FL, as measured by anti-CD19 chimeric antigen receptor (CAR) T-cell expansion and persistence in blood. To characterize the levels of serum/plasma analytes (including cytokines) as well as minimal residual disease (MRD) over time
