Safety of a new, single, integrated, closed photopheresis system in patients with cutaneous T-cell lymphoma

Background Extracorporeal photopheresis (ECP) is an approved palliative treatment for cutaneous T-cell lymphoma (CTCL). The THERAKOS(TM) CELLEX(TM) (continuous flow separation) system (Therakos, Exton, PA, U.S.A.) has been developed from the current THERAKOS(TM) UVAR(R) XTS(TM) system. It is designed to reduce treatment times and extracorporeal volumes, and allows the use of either a single- or a dual-needle configuration. Objectives To assess the safety of the THERAKOS(TM) CELLEX(TM) system to provide ECP for patients with CTCL. Methods Patients received ECP with the THERAKOS(TM) CELLEX(TM) system for up to 6 months. The treatment schedule was defined by their current treatment and response to ECP. At least 150 treatments were required to assess safety of the new system. Safety was assessed using reports of adverse device effects (ADEs) and unanticipated ADEs (UADEs), device malfunctions and defects, vital signs, laboratory parameters and physical examinations. Results Thirteen patients were enrolled and 12 completed the study; 155 ECP treatments were initiated and 153 completed. There were no ADEs or UADEs reported during the study. The mean treatment time was shorter for patients who received dual-compared with single-needle treatments (74.4 vs. 103.0 min, P < 0.0001) and the extracorporeal volume was lower (216 vs. 266 mL). Conclusions This new ECP system provides lower extracorporeal volumes, faster treatment times, and flexibility to use either single- or dual-needle access, while not being associated in this study with any ADEs, and therefore having a positive benefit-risk ratio for patients with CTCL.