A study looking at mogamulizumab and radiotherapy for people with T cell lymphoma of the skin (MOGAT)

Cancer type:

Blood cancers

Lymphoma

Non-Hodgkin lymphoma

Status:

Open

Phase:

Phase 2

This study is looking at an immunotherapy Open a glossary item drug called mogamulizumab with radiotherapy .

It is for people with a type of lymphoma that started in the T cells Open a glossary item 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

More about this trial

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:

light activated drug treatment such as psoralen ultraviolet light treatment (PUVA)
radiotherapy – using x-rays to treat the mycosis fungoides
interferon
chemotherapy

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:

how well mogamulizumab and radiotherapy works for mycosis fungoides that has come back or got worse after treatment
about the safety of mogamulizumab and radiotherapy
about side effects of treatment
about quality of life

Who can enter

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:

have either stage 1B, stage 2A or stage 2B mycosis fungoides when joining the trial
have had at least 1 other treatment that reached your whole body (systemic treatment ) and your mycosis fungoides has come back or got worse. You might be able to take part if you have had psoralen with ultraviolet light therapy (PUVA).
might not be able to do heavy physical work, but can do anything else (performance status 0 or 1)
have satisfactory blood test results
have a normal heart function – you have an ECG and either an ECHO (heart ultrasound) or MUGA to check this
have had at least 3 months break from your last dose of alemtuzumab (Campath) or similar drug, and your CD4+ T cells are above a certain level. Your doctor can explain more.
are willing to use reliable contraception during treatment and for 6 months after the last dose if there is any possibility that you or your partner could become pregnant
are at least 18 years old

Who can’t take part

Cancer related
You cannot join this trial if any of these apply. You:

have had stage 3 or stage 4 mycosis fungoides now, or in the past
have had mogamulizumab or a similar drug before. Your doctor can explain more.
have had total skin electron beam therapy (TSEB) before
have had any treatment that reaches your whole body for your lymphoma in the 4 weeks before joining the study. You might be able to take part if your lymphoma is growing quickly and you have had cancer treatment more recently than this. Your doctor can explain more.
have any side effects from any other cancer treatment, apart from if they are very mild
have had cancer in the past 5 years apart from very early stage (in situ ) fully treated cervical cancer, prostate cancer that has not spread and you have a low amount of PSA in your blood, early stage (in situ) melanoma or non melanoma skin cancer
are planning on having a stem cell transplant as part of your treatment

Medical conditions
You cannot join this trial if any of these apply. You:

have had a serious infection in the 4 weeks before joining the study
have chest pain due to a lack of oxygen reaching the heart muscle (unstable angina)
have had a balloon or metal put into a narrow or blocked artery in the last 6 months (angioplasty or stent)
have had a heart attack in the last 6 months
have shingles when joining the study
have an active autoimmune disease apart from certain ones. The study team check this before you join the study.
are taking medication to damp down your immune system , which is not for your lymphoma, in the 7 days before joining the study. This includes high dose steroids that reach your whole body. You can still take part if you are taking low dose steroids, steroid injections into a joint, steroid eye drops, steroid inhalers or steroid nose drops.
have HIV, HTLV-1, active hepatitis B or active hepatitis C
have had an illness in the last 6 months which has been serious, getting worse or is uncontrolled. Your doctor can explain more.

Other

You cannot join this trial if any of these apply. You:

have a serious mental illness, or difficulties, that the team think would make it difficult for you to take part in the study
have had a very severe reaction (anaphylaxis) to similar drugs to mogamulizumab, or anything that mogamulizumab contains
are pregnant or breastfeeding

Trial design

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 cycles of treatment. Open a glossary item 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 genes Open a glossary item 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:

a blood sample at the start of the study, before and after radiotherapy and if your lymphoma gets worse
a skin sample (skin biopsy ) before the study, before radiotherapy and if your lymphoma gets worse. This is only if you have an area of mycosis fungoides they can take sample from.
a mouth swab at the start of the study – this is to look at DNA from the cells on the inside of your cheek

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:

before you start treatment
at set times during treatment
after you finish treatment

The questionnaires will ask about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

You see the trial doctor to have tests before you can take part. The tests include:

a physical examination, including checking your pulse, blood pressure and height and weight
skin assessment – you might have photos of your skin taken
blood tests
electrocardiogram
MUGA or ECHO
a scan such as a CT scan, MRI scan or PET-CT scan

You might also have:

a urine test
skin biopsy from your lymph node

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:

a physical examination
blood tests
urine tests (if your team think you need one)

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 MRI scan Open a glossary item , 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:

blood tests
a scan
a skin assessment

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:

a blood test and skin assessment every 2 months
a scan with or without a skin biopsy every 4 months

Side effects

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 immune system Open a glossary item . This may cause inflammation and other reactions in different parts of the body. For many people the inflammation and reactions are not too bad. For some people they can cause serious side effects.

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.

If you have any of these side effects tell your doctor or nurse as soon as possible. You should tell them that you are on or have been on an immunotherapy.

Side effects of mogamulizumab include:

lack of energy (fatigue)
constipation
swollen legs or ankles
headaches
skin rash
a reaction to mogamulizumab while having the infusion

Side effects of total skin electron beam therapy (TSEB) include:

skin problems such as dry or itchy skin, cracks in your skin (fissures) or a skin infection
sun sensitivity
feeling very tired (fatigue)
sweating less than normal
swelling of your feet or ankles
brittle nails
hair loss
taste changes
a dry mouth
nose bleeds
dry eyes
stiffness in your hands and feet