Study design and patient population
This Japanese subset analysis is based on patients included in ELARA (NCT03568461), a single-arm, multicenter, phase 2 trial of tisagenlecleucel in adults with r/r FL after ≥ 2 prior lines of therapy or who had relapsed after autologous stem cell transplantation (SCT). The global ELARA trial was conducted across 30 sites in 12 countries worldwide (including the United States, Europe, and Australia, and three sites in Japan) (Fig. Study design. Institutional approval from the Institutional Review Board/Independent Ethics Committee was obtained before initiating the trial. Written informed consent from all patients was obtained prior to screening and patients were enrolled in the study only when they met the clinical eligibility criteria, and their cryopreserved leukapheresis material was accepted by the manufacturing facility.