
"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 looking at acalabrutinib to see if it can improve treatment for people with Richter’s syndrome.
Chronic lymphocytic leukaemia (CLL) can sometimes develop into a condition called Richter’s syndrome. Richter's syndrome is a type of non-Hodgkin lymphoma (NHL).
The usual treatment for Richter’s syndrome is R-CHOP. This is a combination of chemotherapy drugs and a targeted drug called rituximab. This treatment can help but sometimes the lymphoma comes back. So researchers are looking for ways to improve treatment.
In this trial, they are looking at adding a drug called acalabrutinib to R-CHOP. This combination is called RA-CHOP.
Acalabrutinib is a type of targeted cancer drug called a cancer growth blocker. It stops the signals that cancer cells use to divide and grow. We know from early research that it might work for people with Richter’s syndrome.
There are 3 different parts to this trial. Which part you join depends on a few factors such as the treatment you have had in the past. So you have 1 of the following:
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.
There are 3 groups in this trial:
Who can take part
You may be able to join the randomised part of the trial if all of the following apply. You:
To join cohort 1 you joined the randomised part of the trial and had R-CHOP.
To join cohort 2 the following must apply.
You:
As well as the above, for all parts of the trial the following must also apply.
You:
Who can’t take part
You cannot join this trial if any of these apply.
Cancer related
You:
Medical conditions
You:
Other
You:
This is a phase 2 trial. It is taking place in the UK.
There are 3 treatment groups in this trial. Your doctor will tell you which treatment group you go into. You have 1 of the following:
R-CHOP or R-CHOP acalabrutinib
This part of the trial is randomised. You are put into 1 of 2 groups by a computer. Neither you nor your doctor can decide which group you are in. You have 1 of the following:
The trial team need 60 people to join this part of the trial.
Everyone taking part has R-CHOP. You haveEveryone has up to 6 cycles of treatment. This takes about 4 months. Those in the acalabrutinib group might be able to continue to take it for longer if treatment is working.
You stop treatment if it isn’t working. Your doctor will discuss further treatment with you.
Acalabrutinib on its own (Cohort 1)
This part is for people who had R-CHOP in the past, but their Richter’s Syndrome didn’t improve, got worse or came back.
The trial team need 30 people to join this part of the trial.
You have acalabrutinib. It is a capsule. You take them twice a day, everyday. The trial team tell you how many capsules to take.
You have treatment as long as it is working and the side effects aren’t too bad.
R-CHOP and acalabrutinib (Cohort 2)
This part of the trial is for people who were diagnosed with Richter’s Syndrome while taking ibrutinib. Or who had ibrutinib for CLL but it stopped working. Ibrutinib is a type of .
The trial team need 15 people to join this group.
Everyone has R-CHOP and acalabrutinib.
You have treatment in cycles. Each 3 week period is a cycle of treatment. The first day of treatment is called day 1. You:
Everyone has up to 6 cycles of treatment. This takes about 4 months. You might be able to continue to take acalabrutinib for longer if treatment is working.
Samples for research
The researchers ask for samples () from bone marrow tests that you have done as part of your standard care. They also ask to take some extra blood samples. Where possible, you have these at the same time as your routine blood tests.
They also ask you to give a sample of tissue from a lymph node. They ask for a sample before you start treatment and if your cancer gets worse.
They plan to use the samples to work out why treatments work for some people and not others. And to learn more about Richter’s syndrome.
Quality of life
You fill out a questionnaire before starting treatment, at set times during the trial and after finishing treatment. The questionnaire asks about any side effects you have had and about how you have been feeling. This is called a quality of life study.
You see a doctor and have some tests before you can join the trial. These include:
The trial team might also ask you to give a .
You have a:
You have regular check ups when you are on trial treatment. The trial team follow you up every 3 months when you finish treatment 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.
The most common side effects of acalabrutinib include:
The most common side effects of R-CHOP are:
Because they can interfere with the way the drugs work the trial team ask you to avoid:
We have more information about R-CHOP.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Anna Schuh
Blood Cancer UK
Trials Acceleration Program (TAP)
Acerta Pharma
University of Birmingham
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.”