Schéma : This is a multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in adult patients with relapsed or refractory FL.


Study arm:
Experimental: CTL019: tisagenlecleucel single infusion


Main objective of the trial :
Evaluate the efficacy of tisagenlecleucel therapy as measured by CRR determined by IRC

Secondary objectives of the trial:
- Evaluate the efficacy of tisagenlecleucel as measured by additional efficacy measures, including ORR, DOR, PFS and OS
- Evaluate safety of tisagenlecleucel
- Characterize the in vivo cellular kinetics (levels, expansion, persistence) of tisagenlecleucel transduced cells into target tissues (blood, bone marrow, and other tissues if available) and CD3+ tisagenlecleucel cells in peripheral blood, summarized by clinical response
- Characterize the incidence and prevalence of tisagenlecleucel immunogenicity (humoral and cellular)
- Characterize the impact of pre-existing and treatment induced immunogenicity (cellular and humoral) on cellular kinetics, efficacy and safety
- Describe the effect of tisagenlecleucel therapy on Patient reported outcomes (PRO)