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Study to determine the aetiology of chlormethine gel induced-skin drug reaction in early stage mycosis fungoides cutaneous T cell lymphoma (MF-CTCL)

Study documentation

Trial Status All trial activities ended
Dates Date of activation: 29-Mar-2022
Date Step1 close: 23-Mar-2023
Data management at EORTC Yes
Design Phase 2
Not randomized / N.A.
Targeted Sample size EORTC Groups: 100
Treatment Drug
Study Staff Emmanuella Guenova (Study Coordinator) , CHUV - Hopital de Beaumont, Lausanne
Julia Scarisbrick (Study Coordinator) , UHB-Queen Elizabeth Medical Centre, Birmingham
Christian Alfano (Project Manager) , EORTC Headquarters, Brussels
Stephanie Antunes (Clinical Scientist) , EORTC Headquarters, Brussels
Emanuel Buhrer (Project Physician) , EORTC Headquarters, Brussels
Jose Casas (TR Scientist) , EORTC Headquarters, Brussels
Peter De Burghgraeve (Data Manager) , EORTC Headquarters, Brussels
Carolina Fernandes (Clinical Operations Manager) , EORTC Headquarters, Brussels
Beatrice Fournier (Clinical Scientist) , EORTC Headquarters, Brussels
Leslie Herman (Regulatory Affairs Manager) , EORTC Headquarters, Brussels
Hafida Lmalem (Study Designer) , EORTC Headquarters, Brussels
Sara Meloen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Anja Mestnik (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels
Jammbe Musoro (Statistician) , 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)
CHU de Bordeaux - Groupe Hospitalier Saint-Andre - Hopital Saint-Andre (BORDEAUX CEDEX, France)
Centers to be activated Athens University - Attikon University General Hospital (Athens, Greece)
Guy s and St Thomas' NHS - Guy's Hospital (London, United Kingdom)
HELIOS Klinikum Krefeld-Staedt Krankenanstalten Krefeld (Krefeld, Germany)
Muehlenkreiskliniken Johannes Wesling Klinikum Minden (Minden, Germany)
UHB-Queen Elizabeth Medical Centre (Birmingham, United Kingdom)
Protocol summary
NCT number NCT04218825
EudraCT 2019-004891-20
Financial Support Educational Grant