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Southampton Clinical Trials UnitNews

First patients recruited as a major new lymphoma trial opens in Southampton

Published: 13 December 2021
Professor Andrew Davies
Professor Andrew Davies

Scientists in Southampton have launched a major new trial that it’s hoped could improve outcomes for people with an aggressive form of non-Hodgkin lymphoma.

The REMoDL-A trial is being led by researchers at the Cancer Research UK Southampton Centre and the Southampton Clinical Trials Unit (SCTU) at the University of Southampton.

The trial will test whether adding a targeted cancer drug called acalabrutinib to standard chemotherapy could be effective treatment for patients, depending on the genetic profile of their individual cancer.

Around 5,500 people are diagnosed with diffuse large B cell lymphoma (DLBCL) each year in the UK. It develops when the body begins to make abnormal white blood cells that build-up in the lymph nodes and prevent the body from dealing with infections in the normal way.

Standard treatment for DLBCL is a combination of chemotherapy drugs called R-CHOP3. Though this treatment works well for many people, some patients will not see a response, while for others it stops being effective and the lymphoma comes back.

Acalabrutinib works by blocking a protein which has a role in helping lymphoma cells to survive and grow, thereby slowing the progression of the cancer. A previous study4 in a small number of patients looked at the safety and optimal dose of acalabrutinib with R-CHOP for DLBCL. The REMoDL-A trial will now build on this to test acalabrutinib in a larger number of people and see if it can improve the effectiveness of the standard chemotherapy treatment.

Up to 558 patients with previously untreated DLBCL will be recruited into the trial. Each will receive one round of R-CHOP chemotherapy, during which time blood and tumour samples will be sent for molecular profiling to determine the genetic make-up of their cancer. Patients will then be randomised to either continue receiving chemotherapy alone, or to have chemotherapy plus acalabrutinib.

Professor Andrew Davies, Professor of Haematological Oncology and chief investigator of the REMoDL-A trial said: “By looking at the molecular make-up of a patient’s lymphoma and then seeing how they respond to treatment, we hope to be able to determine whether adding acalabrutinib to standard chemotherapy improves outcomes for these patients, and whether people with different molecular profiles respond to the drug in different ways. This information could help us explore the best treatment options for individual patients and help lead to a more personalised approach to treating for DLBCL in the future.”

University Hospital SouthamptonREMoDL-A has recruited its first patients and is now open at University Hospital Southampton, giving DLBCL patients across the south a chance to take part in the trial. Eventually it will open at 50 hospital sites across the UK.

Joshua Caddy, Senior Trials Manager for the lymphoma group at the Southampton Clinical Trials Unit, said: “Our team has vast experience of running lymphoma trials with the aim of improving outcomes and survival for patients. The REMoDL-A study will build on previous work that has already given us a greater understanding of how targeted cancer therapies could be used in this patient group, and we hope this trial could help provide better treatment options for patients with diffuse large B cell lymphoma.”

Jackie Rafferty from Southampton is a lymphoma patient who is working with the team at the SCTU to make sure that the patient voice is represented in decisions about how the REMoDL-A trial is conducted.

“I have a strong interest in any new treatments being researched,” says Jackie. “Although the REMoDL-A trial will not benefit me directly, I am only too pleased to be able to be involved in this study as a patient contributor. Hopefully the outcome of the all the lymphoma research being undertaken in Southampton will enable many people with different types of lymphoma to be cured or to live long lives with cancer.”

REMoDL-A is an independent, academic-led clinical trial which is being funded by an unrestricted educational grant from AstraZeneca. The trial has endorsement from Cancer Research UK, allowing the trial team access to resources to assist in running the study, and with support from the NCRI Lymphoma Group.

Notes for editors

The REMoDL-A trial is a Randomised, phase II, open-label, multicentre study evaluating molecular guided therapy for diffuse large B-cell lymphoma (DLBCL) with acalabrutinib. Read more at https://www.southampton.ac.uk/ctu/trialportfolio/listoftrials/remodla.page

The Southampton Clinical Trials Unit (SCTU) is a Cancer Research UK (CRUK) funded CTU with expertise in the design, conduct and analysis of multicentre, interventional clinical trials. The SCTU is based within the University of Southampton with offices at the University Hospital Southampton NHS Foundation Trust Southampton General Hospital site. (www.southampton.ac.uk/ctu/index.page

Lymphoma is a cancer of the lymphatic system and is divided into two types: Hodgkin lymphoma and non-Hodgkin lymphoma (NHL). There are more than 60 types of non-Hodgkin lymphoma, including diffuse large B cell lymphoma (DLBCL), and these are caused by white blood cells called B lymphocytes dividing abnormally, preventing the body’s usual response to infections. There is more information on lymphoma, NHL and DLBCL on the Cancer Research UK and Lymphoma Action websites.

R-CHOP is the standard treatment for non-Hodgkin lymphomas, including DLBCL. It is a combination of chemotherapy treatments, CHOP - cyclophosphamide, doxorubicin hydrochloride, vincristine (which used to be called Oncovin) and prednisolone (a steroid) – which destroy rapidly-dividing cells such as cancer cells, with the addition of the monoclonal antibody Rituximab which attaches to the cancerous B cells so they can be recognised and destroyed by the immune system.

The ACCEPT trial was a Phase Ib/II combination of acalabrutinib with R-CHOP for patient Diffuse Large B-cell Lymphoma (DLBCL). Phase I to establish dose Limiting toxicity of acalabrutinib combined to R-CHOP, Phase II to establish overall response rate of the combination acalabrutinib and R-CHOP and safety of the combination acalabrutinib and R-CHOP.

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