Active not recruitingPHASE2INTERVENTIONAL

Acalabrutinib in Combination With R-CHOP for Previously Untreated Diffuse Large B-cell Lymphoma (DLBCL)

This study is looking at a common type of blood cancer called Diffuse Large B-cell Lymphoma (DLBCL). For most people, the standard treatment, R-CHOP chemotherapy, works well. However, for some, the cancer either doesn't respond or comes back. Researchers want to see if adding a new drug called acalabrutinib to R-CHOP can improve treatment. Acalabrutinib works by blocking a protein in cancer cells that helps them survive. We hope that by stopping this protein, the treatment will be more effective. Participants will receive one cycle of R-CHOP, and then some will continue with R-CHOP alone, while others will have acalabrutinib added to their R-CHOP treatment.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

University Hospital Southampton NHS Foundation Trust

Enrolment target

453

Start

19 Oct 2021

Estimated completion

01 May 2028

Diffuse Large B Cell Lymphoma

What is this study about?

Diffuse Large B-cell Lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma, which is a cancer that starts in white blood cells. While many people with DLBCL get better with the usual treatment called R-CHOP, some patients find that their lymphoma doesn't respond to this treatment, or it might come back after they've finished their treatment. This is why doctors are always looking for better ways to treat DLBCL.

Researchers believe that a protein called Bruton tyrosine kinase (BTK) plays a role in helping lymphoma cells survive and grow. Acalabrutinib is a new medicine that aims to block this BTK protein. By stopping BTK from working, the idea is that it will make the lymphoma cells more vulnerable and allow the chemotherapy to work more effectively. This study wants to find out if adding acalabrutinib to the standard R-CHOP treatment can improve the chances of a successful outcome for patients who haven't been treated for DLBCL before.

This is a Phase 2 study, which means it's one of the earlier stages of testing a new treatment. The main goal is to see if adding acalabrutinib to R-CHOP is effective enough to be studied further in a larger trial. The study will take place in up to 50 hospitals across the UK and will involve up to 553 patients. By carefully watching how patients respond, doctors hope to learn if this new combination could offer a better way to fight DLBCL.

Key takeaways

This study evaluates adding acalabrutinib to standard R-CHOP for untreated DLBCL.
Acalabrutinib aims to block a protein helping lymphoma cells survive.
Participants will be randomly assigned to R-CHOP alone or R-CHOP with acalabrutinib.
The study assesses if the new combination is good enough for further testing.
Close follow-up will continue for at least 24 months after treatment.

Who may be eligible?

This study is looking for adults aged 16 or older who have recently been diagnosed with Diffuse Large B-cell Lymphoma (DLBCL) and haven't started treatment for it yet. You would need to have evidence of the lymphoma that can be measured, and your doctors would need to confirm that you are generally well enough to receive strong chemotherapy.

Your lymphoma also needs to have a specific marker called CD20. The doctors will also need enough of your lymphoma sample to do further tests to understand its genetic makeup. Unfortunately, some types of DLBCL or those found in specific locations might not be suitable for this study.

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.

Are you 16 years old or older?
Have you recently been diagnosed with DLBCL and not yet started treatment?
Do you have a type of DLBCL that shows a marker called CD20?
Are you generally well enough to have chemotherapy?
Do doctors think your lymphoma needs a full course of treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first receive one cycle of the standard R-CHOP chemotherapy. During this time, the doctors will arrange for more detailed tests on your lymphoma cells. Depending on the results of these tests and a random process (like flipping a coin, but weighted), you'll then either continue to receive another 5 cycles of R-CHOP alone (Arm A), or you'll receive another 5 cycles of R-CHOP along with the new drug, acalabrutinib (Arm B).

If you're in Arm B, you'll take acalabrutinib as tablets, twice a day, continuously over 21-day cycles. All patients will have regular check-ups with the study team to monitor your health and how the treatment is working. After your treatment ends, you'll be followed closely for at least 24 months, with ongoing checks on your health and whether your lymphoma has returned, until researchers have gathered enough information.

Potential risks and benefits

Taking part in a clinical trial may offer the potential benefit of trying a new treatment that could be more effective than current options, especially if your current treatment options are limited. However, there are also potential risks, as new treatments can have side effects that are not yet fully known. The study team will carefully monitor you for any side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (33)

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

Colchester General Hospital
Verified postcode
Colchester, United Kingdom
East Kent Hospitals NHS Foundation Trust
Verified postcode
Canterbury, United Kingdom
Monklands Hospital
Verified postcode
Airdrie, United Kingdom
Victoria Hospital
Verified postcode
Blackpool, United Kingdom
University Hospital Dorset NHS Foundation Trust (Bournemouth and Poole Hospitals)
Verified postcode
Bournemouth, United Kingdom
Queens Hospital
Verified postcode
Burton-on-Trent, United Kingdom
Addenbrooke's Hospital
Verified postcode
Cambridge, United Kingdom
Royal Derby Hospital
Verified postcode
Derby, United Kingdom
Royal Devon and Exeter Hospital
Verified postcode
Exeter, United Kingdom
Beatson West of Scotland Cancer Centre
Verified postcode
Glasgow, United Kingdom
Ipswich Hospital
Verified postcode
Ipswich, United Kingdom
St James Hospital
Verified postcode
Leeds, United Kingdom

Common questions

What is DLBCL?

DLBCL stands for Diffuse Large B-cell Lymphoma. It's a type of cancer that starts in certain white blood cells and is the most common kind of non-Hodgkin lymphoma.

What is R-CHOP?

R-CHOP is the standard treatment for DLBCL. It's a combination of several powerful chemotherapy drugs along with a targeted drug called rituximab.

What is acalabrutinib?

Acalabrutinib is a newer drug being tested. It works by blocking a protein in cancer cells called BTK, which is thought to help the lymphoma cells survive.

Will I definitely get the new drug?

Not everyone in the study will get the new drug. After your first R-CHOP cycle and some tests, you'll be randomly assigned to either receive R-CHOP alone or R-CHOP with acalabrutinib.

How long will I be followed after treatment?

You'll be followed closely for at least two years after your treatment finishes, and potentially longer, to monitor your health and the status of your lymphoma.