title: Safety of a new, single, integrated, closed photopheresis system in patients with cutaneous T-cell lymphoma.
abstract: BACKGROUND
  Extracorporeal photopheresis (ECP) is an approved palliative treatment for cutaneous T-cell lymphoma (CTCL). The THERAKOS CELLEX (continuous flow separation) system (Therakos, Exton, PA, U.S.A.) has been developed from the current THERAKOS UVAR XTS system. It is designed to reduce treatment times and extracorporeal volumes, and allows the use of either a single- or a dual-needle configuration.
  
  
  OBJECTIVE
  To assess the safety of the THERAKOS CELLEX system to provide ECP for patients with CTCL.
  
  
  METHODS
  Patients received ECP with the THERAKOS CELLEX 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.
authors.affiliation: Morristown Memorial Hospital, Morristown, NJ 07960, USA. emil.bisaccia@atlantichealth.org
authors.forename: E
authors.initials: E
authors.lastname: Bisaccia
authors.forename: E C
authors.initials: EC
authors.lastname: Vonderheid
authors.forename: L
authors.initials: L
authors.lastname: Geskin
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004868:Equipment Failure; D005260:Female; D006801:Humans; D016410:Lymphoma, T-Cell, Cutaneous / Q000628:therapy*; D008297:Male; D008730:Methoxsalen / Q000627:therapeutic use; D008875:Middle Aged; D017893:Photopheresis / Q000009:adverse effects / Q000379:methods*; D012878:Skin Neoplasms / Q000628:therapy*; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D008730:Methoxsalen