Condition: Stage IB-IIB Cutaneous T-Cell Lymphoma · Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
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.
This description comes directly from the study's public registry record.
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| University Hospitals Copenhagen - Rigshospitalet | Copenhagen, Denmark | Recruiting |
| CHU de Bordeaux - Groupe Hospitalier Saint-Andre - Hopital Saint-Andre | Bordeaux, France | Recruiting |
| Assistance Publique Hopitaux Paris- APHP Nord - Univ De Paris Cite - Hop. Saint Louis | Paris, France | Recruiting |
| UniversitaetsMedizin Mannheim | Mannheim, Germany | Recruiting |
| Muehlenkreiskliniken Johannes Wesling Klinikum Minden | Minden, Germany | Recruiting |
| Athens University - Attikon University General Hospital | Athens, Greece | Recruiting |
| Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia | Brescia, Italy | Recruiting |
| Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Lazzaro | Torino, Italy | Recruiting |
| Hospital De La Santa Creu I Sant Pau | Barcelona, Spain | Recruiting |
| Hospital Universitario 12 De Octubre | Madrid, Spain | Recruiting |
| Hospital Universitario Puerta De Hierro | Madrid, Spain | Recruiting |
| University Hospitals Birmingham NHS Foundation Trust (UHB) -Queen Elizabeth Medical Centre | Birmingham, United Kingdom | Recruiting |
+ 1 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04128072