Study
EORTC-1820-CLTG
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)
Trial Status
Recruiting
Dates
Date of activation: 21-Feb-2023
Data management at EORTC
Yes
Design
Phase 2
Not randomized / N.A.
Not randomized / N.A.
Targeted Sample size
EORTC Groups: 43 - All Groups: 43
Treatment
Radiotherapy, Drug
Mogamulizumab
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, 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
- Jammbe Musoro (Statistician), EORTC Headquarters, Brussels
- Davide Passariello (Project Manager, 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
NCT number
NCT04128072