RecruitingPhase IIInterventional

Risk-adapted treatment for cancer of the immune system

Large B-cell lymphoma is a type of cancer that affects white blood cells in your immune system. Current standard treatments, called R-CHOP or Pola-R-CHP, cure many people. However, for about one in three people, the cancer either does not respond or comes back later. Doctors currently have no reliable way to predict who is most at risk. The RAdICAL trial aims to change this. Researchers are using blood tests, biopsy samples, and PET scans to identify people whose cancer is at higher risk of returning. All participants start on standard treatment. Those identified as high-risk will receive an added targeted drug called epcoritamab to see if it helps destroy remaining cancer cells. People who are not at high risk continue with standard care alone. The goal is to make treatment more personal and effective for each patient.

At a glance

Status

Recruiting

Phase

Phase II

Sponsor

University of Southampton

Enrolment target

151

Start

01 Sep 2026

Estimated completion

31 Mar 2028

Large B-cell lymphoma

What is this study about?

Large B-cell lymphoma is an aggressive cancer of the immune system. It starts in B-cells, which are specialised white blood cells designed to fight infections. Doctors usually treat this condition with a combination of chemotherapy and targeted antibody medicines, commonly known as R-CHOP or Pola-R-CHP. While these treatments are often successful, around one in three patients find that their lymphoma does not completely go away or returns after treatment.

At present, doctors cannot easily tell at the beginning of treatment who is likely to do well on standard therapy and who might need more intensive care. The RAdICAL study explores whether new testing tools can solve this problem. By looking closely at tissue biopsies, tracking markers in blood samples, and using advanced PET scans, researchers hope to identify high-risk patients very early in their care.

All patients in the study begin with one cycle of standard treatment. During this first stage, the study team runs tests to check each person's risk level. If the tests show a patient is at higher risk of their cancer returning, doctors will add an extra targeted drug called epcoritamab to their treatment plan. Those who are not at high risk will continue with standard treatment alone, avoiding the side effects of extra medication they may not need.

By matching the intensity of treatment to the individual risk of each patient, doctors hope to increase the chances of long-term recovery and cure. This approach, known as 'risk-adapted treatment', aims to give every patient the right amount of care for their specific situation.

Key takeaways

Tests whether new checks can identify patients at higher risk of lymphoma returning.
High-risk patients receive an additional targeted drug called epcoritamab.
Non-high-risk patients receive proven standard treatment alone to avoid unnecessary side effects.
Open to newly diagnosed adults aged 18 to 80 with Large B-cell lymphoma.
Includes six cycles of treatment given every three weeks, followed by two years of health monitoring.

Who may be eligible?

This trial is open to adults aged between 18 and 80 years who have recently been diagnosed with Large B-cell lymphoma. This includes diffuse large B-cell lymphoma (DLBCL) and certain related high-grade B-cell lymphomas. To take part, you must not have received treatment for this lymphoma yet, and your doctor must be planning to treat you with curative standard therapy (such as R-CHOP or Pola-R-CHP).

You will need to be well enough to undergo treatment, although people who need a gentle start to therapy to build up their strength may still be considered. Your study team will also run tests to confirm that your heart, kidneys, liver, and bone marrow are working safely enough to handle the trial medicines.

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.

You are between 18 and 80 years old.
You have newly diagnosed Large B-cell lymphoma.
You have not yet started treatment for this lymphoma.
Your planned treatment is standard therapy (R-CHOP or Pola-R-CHP) aimed at curing the cancer.
Your heart, liver, and kidneys are functioning reasonably well.

Answer every question to see your result.

What does participation involve?

Taking part in this study begins with one three-week cycle of standard treatment. During this first cycle, you will have blood tests, scans, and checks on your original biopsy sample to see if you are in the high-risk group. If you are not in the high-risk group, you will continue with standard treatment every three weeks for a total of six cycles. If tests show you are in the high-risk group, you will receive standard treatment plus the study drug, epcoritamab, followed by two additional doses of epcoritamab after cycle six. Throughout the study, you will have physical examinations, regular blood tests, a CT scan, and up to three PET scans to monitor how well the treatment is working. After finishing treatment, the study team will follow your progress and check on your health for 24 months.

Potential risks and benefits

Taking part in this trial may help clear your lymphoma and lower the chance of it returning, but this cannot be guaranteed. You will also be helping doctors learn how to improve treatments for others in the future. However, joining the trial may mean more hospital visits, extra blood tests, and additional scans. If you receive epcoritamab, you may experience additional side effects, which your doctor will explain in detail. There may also be risks during pregnancy or breastfeeding, so effective contraception is required. Taking part is entirely voluntary, and you are free to leave the trial at any time without your regular NHS care being affected.

Locations (1)

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

Nottingham City Hospital
City only
Nottingham, England

Common questions

What is epcoritamab?

Epcoritamab is a targeted medicine called a bispecific antibody. It works by attaching to both cancer cells and your immune cells, helping your body's natural defences recognise and destroy the lymphoma.

Will I still receive standard treatment if I join the trial?

Yes. Every participant receives standard treatment (either R-CHOP or Pola-R-CHP). The trial looks at whether adding an extra medicine helps those at higher risk.

How do doctors decide if I am in the high-risk group?

During your first round of treatment, doctors use detailed blood tests, PET scans, and laboratory checks on your tumour biopsy to measure your risk level.

What happens if I am not high-risk?

If tests show you are not at high risk, you will simply finish the standard course of treatment without needing the additional study drug.

Can I leave the study if I change my mind?

Yes. You can withdraw from the study at any point without giving a reason, and your medical team will ensure you continue to receive the best standard NHS care.

How to find out more

- RAdICAL Trial Team

radical@soton.ac.uk +44 2381 205154 Official trial record

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