
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a new drug called JNJ-26481585 for cutaneous T cell lymphoma that has come back or got worse despite having other treatment.
Cutaneous T cell lymphoma (CTCL) is a rare type of that affects the skin. You may also hear it called mycosis fungoides or Sezary syndrome.
Doctors can use different treatments for CTCL, but unfortunately the disease usually comes back. In this trial, they are looking at a new drug called JNJ-26481585 to see if it helps people in this situation.
JNJ-26481585 is a drug that blocks substances () 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.
The aims of this trial are to
You may be able to enter this trial if you
You cannot enter this trial if you
This phase 2 trial will recruit about 23 people. Everybody taking part will have JNJ-26481585 capsules that you swallow with a glass of water. You take the capsules on 3 days a week.
As long as you don’t have any bad side effects, you can carry on having JNJ-26481585 for as long as it helps you.
On a number of occasions during the trial, the researchers will ask you to fill in 2 questionnaires. One will ask how your lymphoma is affecting you and about your ability to do daily activities. The other questionnaire will ask about any skin itchiness you may have.
The researchers will also ask you to record when you take the capsules in a diary.
The researchers will take some extra blood samples during the trial. They will use these to learn more about what happens to JNJ-26481585 in your body (), and how your body deals with the drug (
).
They will also ask your permission to take an extra blood sample that they will use to look at your DNA. They want to see how genes affect the way people respond to JNJ-26481585, and how genes affect the side effects they have. This is called pharmacogenomics. If you don’t want to give this sample for research, you don’t have to. You can still take part in the trial.
You will see the trial team and have some tests before you start treatment. The tests include
The trial doctor will take a sample () of lymphoma from your skin or
before you start treatment and again 3 weeks later. If it is not possible to take a biopsy at the beginning of the study, they may be able to use some tissue that was stored when you had a biopsy in the past. But you will still have the second biopsy.
You go to see the trial doctors at least once every 3 weeks during treatment. You have blood tests and an ECG at each visit. You have a CT or MRI scan every 3 months. When you finish treatment, you go back to see the trial team within a month.
If you stop the trial treatment before your lymphoma gets worse, you will continue to see the trial team every 6 to 8 weeks until the trial has completely finished, or your lymphoma gets worse, or you start another treatment. At each visit you have blood tests and fill in questionnaires.
If you stop the treatment because your lymphoma has got worse, you may be able to start another type of treatment. But the trial team will continue to monitor your progress. You will have a hospital appointment or a phone call with them every 3 months.
As JNJ-26481585 is a new drug, there may be side effects the doctors don’t know about yet. Possible side effects include
If you have side effects, the trial doctors can reduce the dose of JNJ-26481585.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Sean Whittaker
Experimental Cancer Medicine Centre (ECMC)
Janssen-Cilag
Freephone 0808 800 4040
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”