Purpose of trial
MF and SS are types of cutaneous (skin) T-cell lymphoma.
Systemic (whole body) treatments can put MF and SS into complete remission (no evidence of disease), partial remission (reduce the disease) or can control the disease (stable disease). However, MF and SS usually come back some time after successful treatment. Maintenance treatments are used after successful treatment and aim to prolong the period that the disease is under control.
This trial aims to find out if giving a drug called 'resminostat' after successful treatment can help to keep advanced stage mycosis fungoides (MF) or Sézary syndrome (SS) under control for longer than if no maintenance is given.
Resminostat is a histone deacetylase inhibitor (a type of cell signal blocker). HDAC inhibitors can disrupt the processes that keep cancer cells alive or that allow them to divide.
Participants are randomised to receive resminostat or placebo (a dummy treatment). The study is blinded, which means you won’t know if you are having resminostat or placebo. You can’t choose which treatment you have and neither can your doctor.
Everyone in the study takes 3 tablets once a day for 5 days then has 9 days off treatment – this is a cycle. You continue with cycles of treatment until your disease is no longer under control or you have side effects bad enough to make you stop it.
Who can enter
Your consultant can give you advice on whether this trial might be suitable for you.
190 people are needed for this trial.
You may be able to enter if:
- You have mycosis fungoides (Stage 2B or higher) or Sézary syndrome that is in remission (complete or partial) or is stable after completing at least 1 previous systemic (whole-body) treatment.
- Your lymphoma is measurable by the tests used in the trial.
- You are well enough to look after yourself and are up and about more than 50% of your waking hours, even if you are not well enough to work.
- Your blood and other health test results are satisfactory.
You will not be able to enter if:
- Your lymphoma is progressing (getting worse).
- You have a long QT interval measured on an electrocardiogram (ECG; a test of the heart’s electrical activity).
- You are having any other treatment for your lymphoma, eg psolaren photo chemotherapy (PUVA), chemotherapy, antibody therapy, hormonal therapy, radiotherapy or experimental treatments.
More information about this trial is available at clinicaltrials.gov.