RecruitingPHASE2INTERVENTIONAL

A Trial of CHOP-R Therapy, With or Without Acalabrutinib, in Patients With Newly Diagnosed Richter's Syndrome

The STELLAR trial is looking at a new way to treat Richter's Syndrome, a type of aggressive blood cancer that can develop from Chronic Lymphocytic Leukaemia (CLL). Currently, treatment for Richter's Syndrome is CHOP-R, but its benefits are often short-lived. This study will compare CHOP-R on its own with CHOP-R plus a new drug called acalabrutinib. Acalabrutinib works by blocking a protein that helps cancer cells grow and has shown promise in some patients with CLL and Richter's Syndrome. The trial wants to see if adding acalabrutinib makes the CHOP-R treatment more effective for people who have just been diagnosed with Richter's Syndrome. Participants will be recruited from special hospitals across the UK.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University of Birmingham

Enrolment target

105

Start

23 Jul 2019

Estimated completion

31 May 2027

Richter Syndrome

What is this study about?

The STELLAR study is looking for better ways to treat Richter's Syndrome. This is a rare and aggressive type of cancer that can develop in some people who have another blood cancer called Chronic Lymphocytic Leukaemia (CLL). While CLL often grows slowly, Richter's Syndrome is much more serious and can be very difficult to treat, with patients often having a short time after diagnosis.

The standard treatment for Richter's Syndrome in the UK is a combination of chemotherapy drugs called CHOP, along with a 'biologic' drug called rituximab (often shortened to CHOP-R). While CHOP-R can help, its effects are often temporary, and the cancer frequently comes back. Because of this, doctors are always looking for new and more effective treatments. This study will test if adding a new drug, acalabrutinib, to the standard CHOP-R treatment can lead to better outcomes for people who have recently been diagnosed with Richter's Syndrome.

Acalabrutinib works differently from chemotherapy. It targets and blocks a specific protein in the cancer cells that helps them grow and multiply. In earlier studies, acalabrutinib has shown promising results in people with CLL and some with Richter's Syndrome. The STELLAR trial aims to find out if combining acalabrutinib with CHOP-R will improve how well the treatment works and help people with newly diagnosed Richter's Syndrome live longer and feel better.

Key takeaways

The STELLAR study is investigating a new treatment for Richter's Syndrome.
It compares standard CHOP-R chemotherapy with CHOP-R plus acalabrutinib (a new drug).
The aim is to see if adding acalabrutinib improves treatment outcomes for newly diagnosed patients.
Participants will undergo various tests and receive treatment cycles in the hospital.
You have the right to withdraw from the study at any time.
This study hopes to find more effective treatments for this aggressive blood cancer.

Who may be eligible?

To join this study, you must have been recently diagnosed with Richter's Syndrome that developed from CLL. Your doctors will need to confirm this with a biopsy. You also need to be well enough to receive the standard CHOP-R chemotherapy.

There are some reasons why you might not be able to take part. For example, if you've already had CHOP or similar strong chemotherapy treatments in the past. If you've had certain other cancers that need ongoing treatment, or if you have specific ongoing infections like Hepatitis B, you may not be able to join. Also, if your cancer has spread to your brain or spinal cord, you would not be able to participate. The study also cannot include individuals who have certain heart problems or who have had a recent stroke. Your care team will check if you meet all the requirements.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I have been newly diagnosed with Richter's Syndrome from CLL.
My biopsy confirms it is DLBCL-type Richter's Syndrome.
I am well enough to have strong chemotherapy (like CHOP-R).
I am aged 16 or older.
I have not had CHOP or similar strong chemotherapy in the past.
I do not have certain other active cancers or severe heart issues.

Answer every question to see your result.

What does participation involve?

If you join the study, you'll have several tests before starting treatment, including a lymph node biopsy, bone marrow samples (usually 3 or 4), blood tests, and special scans called PET-CT and CT scans. The main treatment, CHOP-R, is given in cycles every three weeks, up to six times, and you'll receive this in the hospital. Everyone in the study will get CHOP-R. Half of the participants will also receive acalabrutinib daily, either as a tablet or capsule, alongside their CHOP-R treatment. The other half will receive CHOP-R only.

After you finish your six cycles of CHOP-R, if you were in the group receiving acalabrutinib, you may be able to continue taking it. If you were in the group that only had CHOP-R and your Richter's Syndrome returns, you might then be offered acalabrutinib. Throughout the study, you'll have regular hospital visits for check-ups and further tests, including blood samples and scans, to monitor your health and how well the treatment is working. The study team will explain the full schedule of visits and tests to you.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. The potential benefit of this study is that adding acalabrutinib to CHOP-R *might* improve the effectiveness of your treatment for Richter's Syndrome compared to CHOP-R alone. However, we don't know for sure if it will be better, as that's what the study aims to find out. Acalabrutinib, like all medicines, can have side effects, and adding it to CHOP-R might lead to different or more pronounced side effects than CHOP-R alone. The study team will explain all known side effects for both treatments. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (16)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Belfast City Hospital
Verified postcode
Belfast, United Kingdom· Recruiting
Royal Bournemouth Hospital
Verified postcode
Bournemouth, United Kingdom· Recruiting
University Hospital of Wales
Verified postcode
Cardiff, United Kingdom· Recruiting
Beatson West of Scotland Cancer Centre
Verified postcode
Glasgow, United Kingdom· Recruiting
St James's University Hospital
Verified postcode
Leeds, United Kingdom· Recruiting
Leicester Royal Infirmary
Verified postcode
Leicester, United Kingdom· Recruiting
King's College Hospital
Verified postcode
London, United Kingdom· Recruiting
St Bartholomew's Hospital
Verified postcode
London, United Kingdom· Recruiting
University College London Hospital
Verified postcode
London, United Kingdom· Recruiting
Christie Hospital
Verified postcode
Manchester, United Kingdom· Recruiting
Norfolk and Norwich University Hospital
Verified postcode
Norwich, United Kingdom· Recruiting
Nottingham City Hospital
Verified postcode
Nottingham, United Kingdom· Recruiting

Common questions

What is Richter's Syndrome?

Richter's Syndrome is an aggressive type of cancer that can develop in some people who already have Chronic Lymphocytic Leukaemia (CLL).

What is CHOP-R?

CHOP-R is the standard treatment for Richter's Syndrome in the UK. It's a combination of different chemotherapy drugs (CHOP) and an antibody treatment (rituximab).

What is acalabrutinib?

Acalabrutinib is a newer drug that works by blocking a specific protein in cancer cells, which helps stop them from growing and multiplying.

Will I definitely get the new drug?

If you join the study, you will have a 50/50 chance of being in the group that receives acalabrutinib alongside CHOP-R, or the group that receives CHOP-R alone.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and this will not affect your future medical care.

How to find out more

Joseph Rogers, MSc

stellar@trials.bham.ac.uk +44 (0)121 371 7867 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.