EORTC-1652-CLTG

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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	Closed to Patient Entry
Dates	Date of activation: 12-Sep-2018 Date Step1 close: 21-Nov-2019
Data management at EORTC	Yes
Design	Phase 2 Not randomized / N.A.
Targeted Sample size	EORTC Groups: 29 - All Groups: 29
Treatment	Drug Atezolizumab
Study Staff	Robert Knobler (Study Coordinator) , Universitaetsklinikum Wien - AKH unikliniken, Vienna Rudolf Stadler (Study Coordinator) , Muehlenkreiskliniken Johannes Wesling Klinikum Minden, Minden Jose Casas (TR Scientist) , EORTC Headquarters, Brussels Leslie Herman (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels Jammbe Musoro (Statistician) , EORTC Headquarters, Brussels Valentina Pomella (Clinical Operations Manager) , EORTC Headquarters, Brussels Sandrine Rivrain (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Denisse Tubay (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Katheline Vander Heggen (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels
Type of cancer	Primary Cutaneous Lymphomas
Participating groups	EORTC Cutaneous Lymphoma Tumor Group
Recruiting centers	APHP Nord - Univ De Paris Cite - Hop. 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) Muehlenkreiskliniken Johannes Wesling Klinikum Minden (Minden, Germany) UHB-Queen Elizabeth Medical Centre (Birmingham, United Kingdom) UniversitaetsSpital Zurich - Division of Dermatology (Zurich, Switzerland)
Protocol summary	http://clinicaltrials.gov/study/NCT03357224
NCT number	NCT03357224
EudraCT	2017-003680-35
Financial Support	Educational Grant