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) Open a glossary item 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 Open a glossary item).
 
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 Open a glossary item
  • 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 Open a glossary itemor 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 Open a glossary itemsquamous cell skin cancer Open a glossary item, very early melanoma skin cancer, superficial bladder cancer, CIS Open a glossary item 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 Open a glossary item)


 

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 Open a glossary item. 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 Open a glossary item 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  Open a glossary item
  • a tissue sample of your affected skin (a skin biopsy Open a glossary item)
  • 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 Open a glossary item. 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:

Location

Birmingham
Glasgow
London
Manchester

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Julia Scarisbrick

Supported by

4SC AG

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15513

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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