
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
This trial is for people with blood cancer that has come back or is getting worse despite treatment.
It is for people with one of the following types of blood cancer:
Doctors are looking for new treatments for people with blood cancer that has come back or whose treatment has stopped working. In this trial they are looking at a new drug called CCS1477. It is a targeted drug.
Cancers need certain proteins to grow. These include 2 proteins called p300 and CBP. CCS1477 blocks the action of these proteins. This stops the signals the blood cancer cells use to divide and grow. Researchers hope that CCS1477 will slow the growth of blood cancer. But they aren’t sure so want to find out more.
There are 5 parts in the trial. The part you join depends on the type of blood cancer you have and when you join the trial.
The main aims of the trial are to:
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial 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 you have 1 of the following types of blood cancer that have come back or treatment has stopped working:
As well as the above the following must also apply. You:
Who can’t take part
You cannot join this trial if any of these apply. You:
Medical conditions
You:
Other
You:
This is a phase 1/2 trial. The researchers need 90 people from the UK to take part.
There are 5 parts to this trial. Parts A and B are looking at the best dose of CCS1477 to have. These are dose escalation studies.
Parts C, D, and E are testing this dose in more people. These are dose expansion studies.
Dose escalation groups
Part A | finding the best dose of CCS1477 in people with NHL and myeloma |
Part B | finding the best dose of CCS1477 in people with AML or high risk MDS |
Dose expansion groups
Part C | testing the best dose of CCS1477 in more people with NHL |
Part D | testing the best dose of CCS1477 in more people with myeloma |
Part E | testing the best dose of CCS1477 in more people with AML or high risk MDS |
CCS1477 is a capsule. You take them in the morning with a glass of water. You must fast (water only) for at least 2 hours before taking your trial medication and for at least 1 hour after.
The team tell you how many capsules to take and how often to take them.
Everyone has treatment for as long as it is working and the side effects aren’t too bad.
Part A
This group is for people who have NHL or myeloma. The first few people have a low dose of CCS1477. If they don’t have any side effects the next few people have a higher dose. And so on, until they find the best dose to give.
Part B
This group is for people with AML or high risk MDS. The first few people have a low dose of CCS1477. If they don’t have any side effects the next few people have a higher dose. And so on, until they find the best dose to give.
Part C
This group is for people with NHL. When they find the best dose in part A then part C can open. The team test this dose in 30 people with NHL.
Part D
This group is for people with myeloma. When they find the best dose in part A then part D can open. The team test this dose in 15 people with myeloma.
Part E
This group is for people with AML or high risk MDS. When they find the best dose in part B then part E can open. The team test this dose in 15 people with AML or high risk MDS.
Samples for research
The team ask for a sample of tissue () from when you were first diagnosed. They also collect some samples if you have bone marrow tests as part of the trial.
You give some extra blood samples. Where possible you give these at the same time as your routine blood samples.
The researchers plan to use the samples to:
You see a doctor and have some tests before you join the trial. Everyone taking part has the following:
People with AML, MDS or myeloma also have a bone marrow test.
People with myeloma have scans to look for changes that myeloma can cause in the skeleton or soft tissue. These include 1 of the following:
People with NHL also have:
They might also need to have a bone marrow test.
During treatment
During treatment everyone has a check up with the trial doctor at least:
In the first month of treatment you might need to stay overnight at the hospital or a nearby hotel and return to the hospital in the morning.
People with AML or MDS have a bone marrow test every 2 months for 6 months. After that your doctor decides how often to repeat these tests.
People with myeloma might need to have more bone marrow tests and skeletal surveys during treatment. The team let you know when and if you need to have these.
People with NHL have a scan:
The type of scan you have is the same as you had at the start of the trial. So, it might be a CT scan, MRI scan or PET-CT scan.
Follow up
You see the trial team one month after you stop treatment. They might contact you at home to follow up on any side effects you are having. After that, they contact your GP to see how you are getting on.
The trial 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.
CCS1477 is a new drug and only a few people have had it. So there might be some side effects that we don’t know about yet.
So far, the most common reported side effects in this trial include:
The trial doctor tells you about all the possible side effects of treatment.
CCS1477 can make you more sensitive to sunlight. You should avoid going out in the sun for long periods during treatment and for 4 weeks afterwards. You should cover up and try to stay in the shade. The team advise you to apply a sunscreen that is SPF30 or higher.
You should not take any herbal medication during treatment. Nor should you have large amounts of grapefruit or Seville oranges. These can interfere with how treatment works.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Tim Somervaille
CellCentric Ltd
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.”