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MOGAT: Open-Label, Phase II, Multi-Centre, Study of Anti-CCR4 Monoclonal Antibody (Mogamulizumab) and Total Skin Electron Beam Therapy (TSEB) in Patients With Stage IB-IIB Cutaneous T-Cell Lymphoma
Cutaneous T-Cell Lymphoma (CTCL) has a chronic, relapsing course with patients undergoing multiple, consecutive therapies. Treatment aims at the clearance of skin disease, minimization of recurrence, prevention of disease progression and preservation of quality of life. The treatment of CTCL is primarily determined by the disease extent. Prolonged complete remissions have been obtained with skin-directed therapies in early stage Mycosis fungoides (MF) (IA-IIA), whereas advanced stages CTCL (IIB-IVB) are often refractory to treatment and, thus, have an unfavorable prognosis. Currently, there is no standard treatment option for CTCL, especially for advanced stages, and the optimal treatment sequence is still debated with a large variability in the therapeutic approach across countries. Patients with advanced-stage disease or refractory cutaneous CTCL should be treated with systemic therapies and, whenever possible, should be offered to participate in clinical trials. Currently, there is a urgent call for new treatments in CTCL with higher response rate and prolonged time to progression; In this study, we propose a very innovative treatment schedule in which mogamulizumab is used before Total Skin Electron Beam therapy (TSEB) for systemic disease control and as a maintenance treatment after skin-directed therapy. We hypothesize that our regimen will show a more manageable toxicity profile than a combination treatment and allow for a long-term mogamulizumab administration.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University Hospitals Copenhagen - Rigshospitalet
Copenhagen, Denmark
CHU de Bordeaux - Groupe Hospitalier Saint-Andre - Hopital Saint-Andre
Bordeaux, France
Assistance Publique Hopitaux Paris- APHP Nord - Univ De Paris Cite - Hop. Saint Louis
Paris, France
UniversitaetsMedizin Mannheim
Mannheim, Germany
Muehlenkreiskliniken Johannes Wesling Klinikum Minden
Minden, Germany
Athens University - Attikon University General Hospital
Athens, Greece
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Brescia, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Lazzaro
Torino, Italy
Hospital De La Santa Creu I Sant Pau
Barcelona, Spain
Hospital Universitario 12 De Octubre
Madrid, Spain
Start Date
March 7, 2023
Primary Completion Date
October 1, 2026
Completion Date
January 1, 2027
Last Updated
April 5, 2024
43
ESTIMATED participants
Mogamulizumab
DRUG
Total Skin Electron Beam Therapy (TSEB)
RADIATION
Mogamulizumab (subsequent cycles post TSEB)
DRUG
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Data Source & Attribution
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