*REACH (EORTC 1754-CLTF)
Research type
Research Study
Full title
Study to determine the aetiology of chlormethine gel induced-skin drug reaction in early stage mycosis fungoides cutaneous T cell lymphoma (MF-CTCL)
IRAS ID
291252
Contact name
Julia Scarisbrick
Contact email
Sponsor organisation
European Organisation for Research and Treatment of Cancer
Eudract number
2019-004891-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This study is for adults who have Mycosis Fungoides(MF).
Ledaga is a gel that is already used to treat the skin symptoms of MF. We would like to investigate the skin side effects (allergic or non-allergic) that a participant may develop as a result of taking this treatment. These skin reactions are the most frequent cause of this treatment being interrupted and it is currently not known why these skin reactions happen.
Doctors think that the development of a skin reaction may occur as irritant or allergic or as a result of the drug attacking the lymphoma cells, in the latter this may actually indicate the drug is working and the treatment should be continued. In irritant cases then reducing how often this treatment is given might reduce the likelihood of the skin reaction. In truly allergic patients the drug should be stopped. But there is no proof of this yet, which is why this study is being done.
In the first instance, all participants will be placed in Group A until they experience a skin side effect. If a skin reaction occurs the patient will be patch tested to determine if they are allergic to the treatment. A skin biopsy will also be taken to determine the pathology of the skin reaction. If the patch test result is confirmed to be a non-allergic reaction, the participant can continue in the study and will be placed in Group B where the frequency of applying Ledaga will be reduced. If the participant still cannot tolerate Ledega they will be placed in Group C where a steroid cream will be given alongside Ledaga every other day. Treatment will be continued for 12 months unless complete response or stage progression.
The study will evaluate how well a participant can tolerate Ledaga 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 Ledaga. 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 East Research Ethics Committee
REC reference
22/YH/0186
Date of REC Opinion
23 Apr 2021
REC opinion
Further Information Favourable Opinion