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Phase II trial of atezolizumab (anti-PD-L1) in the treatment of stage IIb-IV mycosis fungoides/sezary syndrome patients relapsed/refractory after a previous systemic treatment

Study documentation

Trial Status Recruiting
Dates Date of activation: 12-Sep-2018
Data management at EORTC Yes
Design Phase 2
Not randomized / N.A.
Targeted Sample size EORTC Groups: 29 - All Groups: 29
Treatment Drug
Study Staff Robert Knobler (Study Coordinator) , Universitaetsklinikum Wien - AKH uniklinieken, Vienna
Rudolf Stadler (Study Coordinator) , Johannes Wesling Klinikum Minden, Minden
Marianna Del Sole (Clinical Research Associate/Monitor) marianna.delsole (at), EORTC Headquarters, Brussels
Laurene Fenwarth (Clinical Research Physician Fellow) laurene.fenwarth (at), EORTC Headquarters, Brussels
Sofia Gomes (Clinical Operations Manager) sofia.gomes (at), EORTC Headquarters, Brussels
Baktiar Hasan (Statistician) baktiar.hasan (at), EORTC Headquarters, Brussels
Leslie Herman (Regulatory Affairs Manager) leslie.herman (at), EORTC Headquarters, Brussels
Alexandra Jouret (Junior Clinical Operations Manager) alexandra.jouret (at), EORTC Headquarters, Brussels
Stephanie Kromar (Regulatory Affairs Manager) stephanie.kromar (at), EORTC Headquarters, Brussels
Arne Maes (Clinical Research Associate/Monitor) arne.maes (at), EORTC Headquarters, Brussels
Fiona Namanya (Clinical Operations Assistant) fiona.namanya (at), EORTC Headquarters, Brussels
Rivka Noelanders (TR Scientist) rivka.noelanders (at), EORTC Headquarters, Brussels
Alexander Parmentier (Clinical Research Associate/Monitor) alexander.parmentier (at), EORTC Headquarters, Brussels
Eluisa Perna (Pharmacovigilance Manager) eluisa.perna (at), EORTC Headquarters, Brussels
Delphine Sartori (Data Manager) delphine.sartori (at), EORTC Headquarters, Brussels
Type of cancer Primary Cutaneous Lymphomas
Participating groups EORTC Cutaneous Lymphoma Task Force
Recruiting centers Assitance Publique - Hopitaux de Paris - Hopital Saint-Louis (Paris, France)
Athens University - Attikon University General Hospital (Athens, Greece)
Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Lazzaro (Torino, Italy)
Guy s and St Thomas' NHS - Guy's Hospital (London, United Kingdom)
Hospital Del Mar (Barcelona, Spain)
Hospital Universitario 12 De Octubre (Madrid, Spain)
Johannes Wesling Klinikum Minden (Minden, Germany)
UniversitaetsMedizin Mannheim (Mannheim, Germany)
UniversitaetsSpital Zurich - Division of Dermatology (Zurich, Switzerland)
Universitaetsklinikum Wien - AKH uniklinieken (Vienna, Austria)
University Hospital St. Poelten (St. Poelten, Austria)
Centers to be activated HELIOS Klinikum Krefeld-Staedt Krankenanstalten Krefeld (Krefeld, Germany)
Leiden University Medical Centre (Leiden, Netherlands)
UHB-Queen Elisabeth Medical Centre (Birmingham, United Kingdom)
Protocol summary
NCT number NCT03357224
EudraCT 2017-003680-35