
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
This study is looking at an drug called mogamulizumab with
.
It is for people with a type of lymphoma that started in the of the skin (cutaneous T cell lymphoma) called mycosis fungoides.
It is for people who have had at least one type of treatment that reached the whole body (systemic), and their lymphoma has either:
• come back or
• got worse
Mycosis fungoides is a very slow growing (low grade) type of T cell lymphoma of the skin.
Doctors can use different treatments for mycosis fungoides. These include:
These treatments can work well to control mycosis fungoides, but for some people their lymphoma comes back or gets worse.
In this study, doctors are looking at a drug called mogamulizumab before and after radiotherapy to see if it helps people in this situation. Mogamulizumab is pronounced mo-gam-u-liz-oo-mab.
Mogamulizumab is a type of immunotherapy called a monoclonal antibody. It helps your immune system attack and destroy the lymphoma cells. Doctors use mogamulizumab without radiotherapy for mycosis fungoides at the moment.
Total skin electron beam therapy (TSEB) is a type of radiotherapy. It’s already a treatment for some people with mycosis fungoides. You can have it to treat larger areas of lymphoma that have not grown too deeply into the skin.
The aims of the trial are to find out:
The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if all of the following apply. You:
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
Medical conditions
You cannot join this trial if any of these apply. You:
This is a phase 2 study. Researchers hope that around 43 people from the UK and Europe will take part.
Everybody taking part has mogamulizumab and total skin electron beam therapy. This is whole body radiotherapy.
You have mogamulizumab as a drip into your bloodstream. You have mogamulizumab as This means you have the drug and then a rest to allow your body to recover. Each cycle is 28 days.
During cycle 1 you have mogamulizumab every week. During cycle 2 you have mogamulizumab every 2 weeks.
You then have a break from mogamulizumab for radiotherapy.
You have radiotherapy four times a week for 2 weeks. So, you have 8 radiotherapy sessions in total.
At least 2 weeks after your last radiotherapy session you start mogamulizumab again. This is cycle 3. You have mogamulizumab every week during cycle 3. For the rest of your cycles, you have mogamulizumab once every 2 weeks.
You have treatment for up to 18 months if it is working, and the side effects are manageable.
Research samples
You give blood samples during the study. The study team use these to learn more about how effect mycosis fungoides treatment.
Where possible, the samples for research are taken at the same time as your routine blood tests.
Extra samples for research
The researchers ask for:
The study team would like to use these samples to learn more about mycosis fungoides, the study treatment and to try and help people in the future.
You don’t have to give these samples if you don’t want to. You can still take part in the study.
Quality of life
The study team will ask you to fill out questionnaire:
The questionnaires will ask about side effects and how you’ve been feeling. This is called a quality of life study.
You see the trial doctor to have tests before you can take part. The tests include:
You might also have:
Cycle 1 and 2 of mogamulizumab
You go to the hospital either once a week or once every 2 weeks for your mogamulizumab drip. Each treatment takes about an hour. You see a member of the team for a blood test before your mogamulizumab and they see how you are getting on.
Before cycle 2 you have some tests, these include:
Radiotherapy
After your first two cycles of immunotherapy and before your radiotherapy starts you have tests. These are similar to the ones you have when you have mogamulizumab. You also have a skin assessment.
You might have some extra tests if your team think you need them. These are:
• a scan - such as an , CT scan or PET-CT scan
• a skin biopsy from a lymph node
Each radiotherapy treatment will last for 30 to 45 minutes. You see your radiotherapy doctor and have blood tests every week during radiotherapy. The radiotherapy team monitors your treatment closely.
Cycle 3 onwards
You usually have the same tests as you did for cycle 1 and 2. You have them at the start of each cycle and when you have your treatment.
Tests for lymphoma during treatment
Every 2 months you have a blood test to look for lymphoma.
Every 4 months you have a scan. And you might have a skin biopsy taken from your lymph node if your team thinks this is needed.
You see the team at week 48 and have:
You can still see the study team if your lymphoma has got worse during treatment. Although you will not be able to have mogamulizumab as part of the study.
Follow up
Around 30 days after your last dose of mogamulizumab you go to the hospital for a follow up visit. The team see how you are getting on. You have some of the same tests you had during your treatment visits.
You see the study team for up to 30 months after you started the study treatment. They see how you are getting on and you have:
The study team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
Mogamulizumab can affect the These side effects could happen during treatment or months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for. |
Side effects of total skin electron beam therapy (TSEB) include:
We have more information about:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Julia Scarisbrick
European Organisation for Research and Treatment of Cancer (EORTC)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”