EORTC-1820-CLTG

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Open-Label, phase II, Multi-Center, study of Anti-CCR4 Monoclonal Antibody (mogamulizumab) Plus Total Skin Electron Beam therapy (TSEB) in patients with stage IB-IIB Cutaneous T-Cell Lymphoma (MOGAT)

Study documentation

Trial Status	Recruiting
Dates	Date of activation: 21-Feb-2023
Data management at EORTC	Yes
Design	Phase 2 Not randomized / N.A.
Targeted Sample size	EORTC Groups: 43 - All Groups: 43
Treatment	Radiotherapy, Drug Mogamulizumab
Study Staff	Pablo Luis Ortiz Romero (Study Coordinator) , Hospital Universitario 12 De Octubre, Madrid Stephanie Antunes (Clinical Scientist) , EORTC Headquarters, Brussels Jessica Berger (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels Emanuel Buhrer (Project Physician) , EORTC Headquarters, Brussels Jose Casas (TR Scientist) , EORTC Headquarters, Brussels Enrico Clementel (QART Manager) , EORTC Headquarters, Brussels Coreen Corning (QART Manager) , EORTC Headquarters, Brussels Richard Cowan (Study Co-Coordinator) , The Christie NHS Foundation Trust, Manchester Carolina Fernandes (Clinical Operations Manager) , EORTC Headquarters, Brussels Claire Gandilhon (Clinical Operations Assistant) , EORTC Headquarters, Brussels Amaya Gonzalez (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels Jammbe Musoro (Statistician) , EORTC Headquarters, Brussels Jan Nicolay (Study Co-Coordinator) , UniversitaetsMedizin Mannheim, Mannheim Davide Passariello (Project Manager) , EORTC Headquarters, Brussels Davide Passariello (Project Manager) , EORTC Headquarters, Brussels Sandrine Rivrain (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Nathalie Ropson (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Luiza Souza (QART Manager) , EORTC Headquarters, Brussels Tsvetelina Stefanova (Data Manager) , EORTC Headquarters, Brussels Katheline Vander Heggen (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels Tim Verbiest (Study Designer) , EORTC Headquarters, Brussels Christine de Balincourt (Lead CRA) , 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) Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (Brescia, Italy) CHU de Bordeaux - Groupe Hospitalier Saint-Andre - Hopital Saint-Andre (BORDEAUX CEDEX, France) Hospital De La Santa Creu I Sant Pau (Barcelona, Spain) Hospital Universitario 12 De Octubre (Madrid, Spain) Hospital Universitario Puerta De Hierro (Majadahonda, Spain) Ludwig-Maximilians-Universitaet Muenchen - Klinik und Poliklinik für Dermatologie und Allergologie - Innenstadt (Muenchen, Germany) Muehlenkreiskliniken Johannes Wesling Klinikum Minden (Minden, Germany) Rigshospitalet (Copenhagen, Denmark) The Christie NHS Foundation Trust (Manchester, United Kingdom) UHB-Queen Elizabeth Medical Centre (Birmingham, United Kingdom) UniversitaetsMedizin Mannheim (Mannheim, Germany)
Centers to be activated	Charite - Universitaetsmedizin Berlin - Campus Mitte (Berlin, Germany) Universitaetsklinikum Schleswig-Holstein - Campus Kiel (Kiel, Germany)
Protocol summary	http://clinicaltrials.gov/study/NCT04128072
NCT number	NCT04128072
EudraCT	2019-004566-17
Financial Support	Kyowa Kirin