A trial of R-CHOP and acalabrutinib for people with Richter’s syndrome (STELLAR)

Cancer type:

Blood cancers
Chronic leukaemia
Chronic lymphocytic leukaemia (CLL)
High grade lymphoma
Leukaemia
Lymphoma
Non-Hodgkin lymphoma

Status:

Open

Phase:

Phase 2

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). 

More about this trial

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: 

  • R-CHOP
  • acalabrutinib on its own
  • R-CHOP and acalabrutinib

The main aims of the trial are to:

  • compare R-CHOP with RA-CHOP
  • see if acalabrutinib improves treatment 
  • learn more about the side effects

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. 

There are 3 groups in this trial:

  • the randomised part Open a glossary item
  • group 1 (or cohort 1)
  • group 2 (or cohort 2)

Who can take part
You may be able to join the randomised part of the trial if all of the following apply. You:

  • are suitable to have R-CHOP
  • haven’t had R-CHOP in the past 
  • have chronic lymphocytic leukaemia (CLL) and newly diagnosed Richter’s syndrome
  • haven’t had a drug called ibrutinib in the last 4 weeks

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:

  • have newly diagnosed Richter’s syndrome
  • have had ibrutinib in the last 4 weeks
  • haven’t had R-CHOP in the past 

As well as the above, for all parts of the trial the following must also apply. 
You:

  • are well enough to be up and about for at least some of each day, even if you need help looking after yourself (performance status 0, 1, 2 or 3
  • are willing to use reliable contraception during the trial and for 12 months afterwards if there is any chance you or your partner could become pregnant 
  • are at least 18 years old

Who can’t take part

You cannot join this trial if any of these apply. 

Cancer related 
You:

  • have had acalabrutinib in the past
  • have CLL or a type of NHL called diffuse large B cell lymphoma (DBCL) in the brain or spinal cord
  • have any other cancer that needs treatment apart from basal cell skin cancer Open a glossary item, carcinoma insitu (CIS Open a glossary item) of the cervix or squamous cell skin cancer Open a glossary item
  • have had an experimental treatment as part of a clinical trial in the last 4 weeks or you are taking part in a trial 

Medical conditions
You:

  • have a problem with how your blood clots 
  • are having treatment to thin your blood such as warfarin
  • have had major surgery within 30 days of being put into a treatment group 
  • have a problem with your gut that affects how you absorb medication 
  • have a problem with your heart such as angina, congestive heart failure or an abnormal heart beat that isn’t well controlled with medication
  • have had a stroke in the last 6 months or a bleed into the brain 
  • have a long term infection that isn’t getting better with treatment or any active infection such as TB or a hepatitis B infection
  • have HIV
  • have any other medical condition or mental health problem that means the trial team think you won’t be able to take part 

Other
You:

  • are allergic to any of the drugs in the trial
  • have a problem with drugs or alcohol 
  • are pregnant or breastfeeding

Trial design

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 and acalabrutinib (randomised part of trial)
  • acalabrutinib only (cohort 1)
  • R-CHOP and acalabrutinib (cohort 2)

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:  

  • R-CHOP (standard treatment)
  • R-CHOP and acalabrutinib (RA-CHOP)

The trial team need 60 people to join this part of the trial. 

Everyone taking part has R-CHOP. You have treatment in cycles Open a glossary item. Each 3 week period is a cycle of treatment. The first day of treatment is called day 1. You:

  • have the chemotherapy drugs as a drip into a vein on day 1
  • take prednisolone tablets on day 1 to day 5
  • take acalabrutinib capsules, twice a day on days 6 to day 21

Everyone 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 targeted drug Open a glossary item.

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:

  • have the chemotherapy drugs as a drip into a vein on day 1
  • take prednisolone tablets on day 1 to day 5
  • take acalabrutinib capsules twice a day, everyday on day 6 to day 21 

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 (biopsies Open a glossary item) 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

Hospital visits

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 sample of tissue from a lymph node Open a glossary item.

You have a:

  • CT scan after 4 cycles of treatment 
  • PET-CT scan after 6 cycles of treatment or if the CLL gets worse  

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.

Side effects

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:

  • headaches
  • an increased risk of infection 
  • an increased risk of bruising and bleeding such as nose bleeds
  • an increased risk of tiredness and breathlessness (anaemia Open a glossary item)
  • diarrhoea or constipation
  • feeling or being sick
  • skin rash 
  • muscle, joint or tummy (abdominal) pain 
  • tiredness (fatigue) or a lack of energy
  • dizziness
  • developing a second cancer  Open a glossary item
  • an abnormal heart rhythm  called atrial fibrillation 
     

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:

  • grapefruit, grapefruit juice, Seville orange juice
  • herbal remedies or dietary supplements (especially St John’s Wort) 
  • medications to reduce the amount of acid your stomach makes if you are having acalabrutinib. These include drugs such esomeprazole (Nexium) and omeprazole.

We have more information about R-CHOP.

Location

Bournemouth
Cardiff
Glasgow
Leeds
Leicester
London
Manchester
Norwich
Nottingham
Oxford
Plymouth
Sheffield
Southampton

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Anna Schuh

Supported by

Blood Cancer UK
Trials Acceleration Program (TAP) 
Acerta Pharma
University of Birmingham 

Freephone 0808 800 4040

Last review date

CRUK internal database number:

16164

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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