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.

Targeted Sample size

EORTC Groups: 43 - All Groups: 43

Treatment

Radiotherapy, Drug
Mogamulizumab

Study Staff

  • Justine Bobinnec (Study Coordinator), EORTC Liaison Office France, Paris
  • Kirsten Brade (Study Coordinator), EORTC Liaison Office Germany, Berlin
  • Ivan Jelas (Study Coordinator), EORTC Liaison Office Germany, Berlin
  • Julie Kitcheman (Study Coordinator), EORTC Liaison Office UK , Leeds
  • Pablo Luis Ortiz Romero (Study Coordinator), Hospital Universitario 12 De Octubre, Madrid
  • Susanne Ziegler (Study Coordinator), EORTC Liaison Office Germany, Berlin
  • Richard Cowan (Study Co-Coordinator), The Christie NHS Foundation Trust, Manchester
  • Jan Nicolay (Study Co-Coordinator), UniversitaetsMedizin Mannheim, Mannheim
  • Davide Passariello (Project Manager), EORTC Headquarters, Brussels
  • Bert Dhondt (Clinical Research Physician), EORTC Headquarters, Brussels
  • Stephanie Antunes (Clinical Scientist), EORTC Headquarters, Brussels
  • Jammbe Musoro (Statistician), EORTC Headquarters, Brussels
  • Yusra Fatima (Statistical Analyst), EORTC Headquarters, Brussels
  • Krista Verhoeft (TR Scientist), EORTC Headquarters, Brussels
  • Carolina Fernandes (Clinical Operations Manager), EORTC Headquarters, Brussels
  • Sofiane Bendiab (Junior Clinical Operations Manager), EORTC Headquarters, Brussels
  • Peter De Burghgraeve (Data Manager), EORTC Headquarters, Brussels
  • Tsvetelina Stefanova (Data Manager), EORTC Headquarters, Brussels
  • Tim Verbiest (Study Designer), EORTC Headquarters, Brussels
  • Bart Meulemans (Clinical Data Expert), EORTC Headquarters, Brussels
  • Sandrine Rivrain (Pharmacovigilance Manager), EORTC Headquarters, Brussels
  • Denisse Tubay (Pharmacovigilance Manager), EORTC Headquarters, Brussels
  • Leslie Herman (Regulatory Affairs Manager), EORTC Headquarters, Brussels
  • Nathalie Ropson (Regulatory Affairs Manager), EORTC Headquarters, Brussels
  • Jessica Berger (Clinical Research Associate/Monitor), EORTC Headquarters, Brussels
  • Luminita Copaceanu (Lead CRA), EORTC Headquarters, Brussels
  • Salvatore Mazza (Lead CRA), EORTC Headquarters, Brussels
  • Enrico Clementel (RTQA Manager), EORTC Headquarters, Brussels
  • Coreen Corning (RTQA Officer), EORTC Headquarters, Brussels
  • Luiza Souza (RTQA Officer), 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)

Protocol summary

NCT number

NCT04128072

EudraCT