* MOGAT (EORTC 1820-CLTF)
Research type
Research Study
Full title
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
IRAS ID
302039
Contact name
Richard Cowan
Sponsor organisation
European Organisation for Research and Treatment of Cancer
Eudract number
2019-004566-17
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 10 months, 2 days
Research summary
This study is for adults who have Mycosis Fungoides(MF) that has not responded to previous treatment or has worsened after an initial improvement.
We would like to investigate whether giving an immunotherapy treatment called mogamulizumab before and after radiotherapy is more effective than total skin electron beam therapy (TSEB) or immunotherapy alone.
Mogamulizumab is approved in Europe and the US for treatment of MF and Sezary Syndrome (SS) and is particularly effective at treating the blood. Doctors think that giving immunotherapy before and after TSEB may delay the progression of the disease but there is no proof of this yet, which is why this study is being done.
All participants will receive 2 cycles of mogamulizumab, followed by TSEB for two weeks (4 times a week). After completing TSEB, treatment with mogamulizumab will restart. This will continue for 18 months (since treatment start) provided that the patient tolerates it and does not progress.
In total, patients will receive 2 cycles of mogamulizumab before TSEB and a maximum of 16 cycles after TSEB
The study will evaluate how well a participant can tolerate mogamulizumab and TSEB by regular clinical examinations and blood tests. The study has an optional translational research component where blood samples and tissue will be collected. These samples might help us to improve the treatment schedule with mogamulizumab and TSEB. It can also inform us on how to better treat patients with MF in the future.
This study will take place in NHS sites in the UK as part of a wider international study. The study is sponsored and coordinated by the EORTC (European Organisation for Research and Treatment of Cancer), a non-profit organisation based in Brussels.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
22/YH/0190
Date of REC Opinion
10 Dec 2021
REC opinion
Further Information Favourable Opinion