"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial of CCS1477 for some types of blood cancer
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:
More about this trial
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:
- find the best dose of CCS1477
- find out what happens to CCS1477 in the body
- learn about the side effects
- find out how well treatment works
Who can enter
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:
- B cell non-Hodgkin lymphoma
- T cell non-Hodgkin lymphoma
- acute myeloid leukaemia (AML)
- high risk myelodysplastic syndrome (MDS)
As well as the above the following must also apply. You:
- have had at least 2 different
standard treatmentsfor blood cancer in the past. You might be able to take part if there are no standard treatments available or you wouldn’t be suitable to have them.
- 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 3 months afterwards if you or your partner could become pregnant. You are willing to use a condom during treatment and for 1 week after if you are a man and can pass your sperm to another person.
- are at least 18 years old
Who can’t take part
You cannot join this trial if any of these apply. You:
- have lymphoma in the brain or spinal cord, cancer that has spread to the tissue that covers the brain or spinal cord or a condition called
spinal cord compression
- have had chemotherapy, an anti cancer drug, an
immunotherapyor an experimental treatment in the last 14 days or a treatment that hasn’t completely cleared your body
- have had radiotherapy to more than 30% of the bone marrow within 4 weeks of trial treatment or in the last 2 weeks before you start treatment if you had radiotherapy to help with symptoms (
- have had another cancer in the past apart from
non melanoma skin canceror carcinoma insitu ( CIS) that has been successfully treated. Or you had treatment for another cancer with the aim to cure it and there have been no signs of it for at least 6 months.
- have had major surgery within 4 weeks of starting trial treatment
- take more than 10mg of prednisolone each day or a similar drug and dose and you have had this within 2 weeks of starting trial treatment
- have side effects from past treatments that aren’t getting better unless they are mild apart from hair loss or moderate numbness and tingling in the hands or feet (
- have a heart or lung condition that is severe or isn’t well controlled with medication. For example, you have congestive heart failure that is causing problems, high blood pressure or angina that isn’t well controlled with medication
- have a heart condition called a QT prolongation
- take medication for high cholesterol (statins) that you can’t stop taking. You should never stop taking a medication without first talking to your doctor.
- have an active infection including hepatitis B, hepatitis C or HIV
- have a medical condition that means you are more likely to have a bleed
- have taken any medication that blocks an enzyme called CYP3A4 in the 4 weeks before joining this trial
- have taken herbal medicine in the 7 days before starting trial treatment or you have taken St John’s wort in the last month
- have any other medical condition or mental health problem that the trial team think would affect you taking part in this trial
- have a severe allergy to CCS1477 or anything it contains
- are pregnant or breastfeeding
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.
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.
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.
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.
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.
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 (
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:
- look for
- find out what happens to the drug in the body (
- find out more about how treatment works
You see a doctor and have some tests before you join the trial. Everyone taking part has the following:
- physical examination
- heart trace (
- blood tests
- urine tests
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:
- CT scan or MRI scan
- PET-CT scan
They might also need to have a bone marrow test.
During treatment everyone has a check up with the trial doctor at least:
- once a week in the first month of treatment
- once or twice a month after that
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:
- at 8 weeks
- every 3 months after that until the lymphoma gets worse
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.
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:
- a drop in the number of blood cells causing an increased risk of bruising or bleeding, breathlessness, tiredness and looking pale
- changes in blood tests that show how the liver is working
- kidney changes
- feeling sick
- loss of appetite
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.
How to join a clinical trial
Professor Tim Somervaille