This study is for adults with Mycosis Fungoides (MF) whose disease has not improved with previous treatment or has come back after improving for a while.
We are looking at whether a treatment called mogamulizumab (an immunotherapy) works better when it is given before and after radiotherapy, compared with:
- radiotherapy alone (total skin electron beam therapy, or TSEB), or
- immunotherapy alone.
Mogamulizumab is already approved in Europe and the United States for treating MF and Sézary Syndrome (SS). It is known to be especially helpful for treating cancer cells in the blood. Doctors believe that giving mogamulizumab both before and after TSEB might help delay the disease from getting worse, but this has not yet been proven. That is why this study is being done.
What treatment will participants receive?All participants in this study will receive:
- Two cycles of mogamulizumab,
- Followed by two weeks of TSEB (4 sessions per week),
- Then mogamulizumab will restart after radiotherapy and may continue for up to 18 months from the start of treatment, as long as:
- the treatment is tolerated, and
- the disease does not progress.
In total, participants may receive 2 cycles before TSEB and up to 16 cycles after TSEB.
How will we monitor your health?We will regularly check how well you are tolerating the treatment using:
- physical examinations
- blood tests
There is also an optional research component. If you agree, we may collect extra blood samples or small tissue samples. These may help us:
- improve future treatment schedules using mogamulizumab and TSEB
- better understand how to treat patients with MF
This study will be carried out at NHS hospitals in the UK, as part of a larger international research project.
It is run by the European Organisation for Research and Treatment of Cancer (EORTC), a nonâprofit organisation based in Brussels.