EORTC-1820-CLTG

Back to Clinical Trials Database

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) 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) Ludwig-Maximilians-Universitaet Muenchen - Klinik und Poliklinik für Dermatologie und Allergologie - Innenstadt (Muenchen, 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