A study of resminostat for T cell lymphoma of the skin (RESMAIN)

Cancer type:

Low grade lymphoma

Lymphoma

Non-Hodgkin lymphoma

Status:

Open

Phase:

Phase 2

This study is looking at resminostat for people with T cell lymphoma of the skin that is stable after recent treatment to the whole body.

More about this trial

Cutaneous T cell lymphoma (CTCL) is a rare type of lymphoma that affects the skin. The most common types are:

Mycosis fungoides
Sezary syndrome

Doctors can use different treatments for T cell lymphoma of the skin, but unfortunately the disease usually gets worse at some point.

In this study, researchers are looking at a new drug called resminostat. They think it might work for people with advanced skin lymphoma but they aren’t sure, so want to find out more.

Resminostat is a drug that blocks substances (enzymes) in the body called histone deacetylases (pronounced dee-as-et-isle-azes). Cells need these to grow and divide. Blocking them may stop cancer growing. Drugs that block these enzymes are called histone deacetylase inhibitors or HDAC inhibitors. We know from research that other HDAC inhibitors can help people with CTCL. For example the drugs vorinostat and romidepsin.

In this study, some people have resminostat and some have a dummy drug (placebo).

The aims of this study are to:

see if resminostat prevents or delays skin T cell lymphoma coming back or getting worse
learn more about the side effects
find out about quality of life
find out what happens to the drug in the body

Who can enter

The following bullet points list 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 study if all of the following apply.

You:

have Mycosis fungoides with at least 1 or more lumps in the skin or it has spread elsewhere in the body (stage 2B to stage 4B) or you have Sezary syndrome
have had at least one treatment to the whole body (systemic treatment) for example interferon or chemotherapy
have T cell lymphoma of the skin that got better or is stable after your last treatment
are well enough to be up and about for at least half the day (performance status 0,1 or 2)
have satisfactory blood test results
are willing to use reliable contraception during treatment and for 30 days afterwards for men and for 3 months afterwards for women if there is any chance you or your partner could become pregnant
are at least 18 years old

Who can’t take part

You cannot join this study if any of these apply.

Cancer related

You:

have T cell lymphoma of the skin that got worse during or after your last treatment
have lymphoma that has spread to the brain or spinal cord
are having any other treatment for CTCL for example PUVA, chemotherapy, immunotherapy or an experimental treatment
haven’t recovered from side effects from past treatments unless they are mild apart from hair loss

Medical conditions

You:

have problems with your heart, such as a heart attack in the last 6 months, high blood pressure that is not well controlled, angina that is not well controlled, an abnormal rhythm of your heart, congestive heart failure or severe problems with the valves in your heart
have a heart condition called QTc prolongation
have extra risk factors for a heart condition called torsade de pointes such as a family history of an abnormal heart rhythm called long QT syndrome
take medications that prolong the QTc interval in your heart
have had another cancer apart from basal cell skin cancer, squamous cell skin cancer, very early melanoma skin cancer, superficial bladder cancer, CIS of the cervix that was successfully treated or any other cancer that was successfully treated more than 3 years ago
have any other medical condition or mental health problem that the study team think would affect you taking part

Other

You:

have had an allergic reaction to similar types of drugs or their ingredients in the past
have problems with drugs or alcohol
are pregnant or breastfeeding

Trial design

This is a phase 2 study. The researchers need 190 people to take part.

It is a randomised trial. You are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.

You have 1 of the following:

resminostat
a dummy drug (placebo)

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Treatment

Resminostat is a tablet. You have treatment in cycles. Each treatment period is 14 days.

The first day of each treatment cycle is called day 1. You:

take resminostat or the dummy drug on day 1 to day 5 (for 5 days in total)
then have 9 days without treatment (day 6 to day 14)

You have treatment for as long as it is working and the side effects aren’t too bad.

Quality of life

The study team will ask you to fill out a questionnaire before you start treatment and at set times during treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study. The researchers will also ask you to fill in a questionnaire to rate how itchy your skin is.

Samples for research

You give some extra blood samples during treatment. You give the samples at specific times and the study team will give you more information about this. They plan to use the samples to:

see how well the treatment is working
find out what happens to the drugs in the body
look for biomarkers to predict who will benefit from treatment

The doctors will ask permission to collect 2 extra tissue samples. You do not have to agree to give these samples if you don’t want to. You can still take part in the study.

Hospital visits

You see a doctor and have some tests before you can take part. These include:

physical examination
blood samples
heart trace
a tissue sample of your affected skin (a skin biopsy)
CT scan

You see a doctor and have some blood tests before you start each cycle of treatment.

For the first 2 cycles of treatment you also go to hospital on day 8 of each treatment cycle for a check up.

In cycle 3 you go to hospital on day 1 and day 5. You have some extra blood tests to see what happens to the drug in the body. These are called pharmacokinetic tests. These visits can take between 5 and 8 hours.

After that you go to hospital every 2 weeks.

You have a CT scan or MRI scan every 3 months.

When you finish treatment, you see the study team 1 month later.

Follow up

The study team will contact you by phone to see how you are getting on for up to 3 years.

Side effects

As resminostat is a new drug, there may be some side effects we don’t know about yet. The study team will monitor you during the time you have treatment and you’ll have a phone number to call if you are worried about anything.

The possible side effects are: