Improving the outlook for patients with lymphoma - first patient enters ARGO trial
ARGO is a randomised controlled trial managed at the Southampton Clinical Trials Unit
Lymphoma is a cancer of cells of the immune system. It develops when lymphocytes (a type of white blood cell) start to divide in an uncontrolled way. T-Cell Lymphomas are divided into 2 main groups; Hodgkin lymphoma and non-Hodgkin lymphoma (NHL), which behave differently and need different treatment. Diffuse large B-cell lymphoma (DLBCL) is the most common type of high-grade (fast-growing) non-Hodgkin lymphoma.
Some patients with DLBCL do not respond to initial treatment (refractory), or may respond only for the lymphoma to return (relapsed). A number of patients with relapsed or refractory DLBCL can be treated with high dose therapy followed by a transfusion of their own stem cells (autologous stem cell transplantation) to treat their disease. This is not always an option for many patients due to ill health or older age, and even for those who are able to undergo high dose therapy it still may not be effective. There are currently no standard treatments available for patients in this situation; the ARGO trial aims to address this.
ARGO is a randomised controlled trial looking at treating these relapsed/refractory patients using a combination called R-GemOx (rituximab, gemcitabine and oxaliplatin) with patients randomly assigned to also receive a new drug called atezolizumab. GemOx is a well-known and well-tolerated chemotherapy treatment. Rituximab is commonly used in DLBCL as it works by targeting a protein on the B-cells called CD20, which helps to trigger the body’s immune system. Atezolizumab is part of a new group of drugs called checkpoint inhibitors, it specifically targets a protein (PD-L1) which is proven to enhance the immune system’s ability to fight cancer. One quarter of patients will receive 6 cycles of R-GemOx. The remaining patients will receive R-GemOx with the addition of atezolizumab from cycle 2 to cycle 6 followed by a year of maintenance therapy.
The ARGO trial is endorsed by CRUK1 and supported by ROCHE2 (pharmaceutical company) as an Investigator Initiated Study. The trial is sponsored by UHS NHS trust4 and is being managed though the Southampton Clinical Trials Unit3 (SCTU). The SCTU is based in the new Centre for Cancer Immunology (CCI) 5, which opened recently following a successful public funding campaign.
Dr Andy Davies, Associate Professor and Consultant in Medical Oncology within Medicine at the University of Southampton, said: “For some patients who have relapsed/refractory diffuse large B-cell lymphoma they are not able to tolerate further high dose therapy. ARGO will find out whether this combination of treatments will benefit these patients. We urgently need trials like this to help improve survival for these patients”. http://www.cancerresearchuk.org/our-research/researchers/dr-andrew-davies
1. Cancer Research UK www.cancerresearchuk.org
2. ROCHE www.roche.com
3. The Southampton Clinical Trials Unit (SCTU) is a UKCRC registered CTU with expertise in the design, conduct and analysis of multicentre interventional clinical trials. We work in partnership with investigators to deliver high quality trials that will directly influence routine clinical practice. www.southampton.ac.uk/ctu
4. University Hospital Southampton NHS Foundation Trust is one of the largest acute teaching trusts in England, with an annual spend of £700 million at three sites across the city of Southampton. It provides hospital services for 1.9 million people living in Southampton and southern Hampshire. With specialist services including neurosciences, respiratory medicine, cancer, cardiovascular, obstetrics and specialist children’s services to more than 3.7 million people in central southern England and the Channel Islands. Every year more than 10,500 staff, including more than 700 consultants, professors and senior lecturers, see 585,000 people at outpatient appointments, deal with 120,000 attendances at the emergency department and treat 150,000 admitted emergency, inpatient or day case patients. In addition, the Trust delivers more than 100 outpatient clinics across the South of England to keep services local for patients. Providing these services costs £1.9 million per day.
5. Building on its cancer immunology research expertise and recent successes in immunotherapy trials, the University of Southampton has completed a major fundraising campaign to raise £25m to open the UK’s first dedicated Centre for Cancer Immunology at Southampton General Hospital in 2017. The Centre will be the first of its kind in the UK and will bring together world-leading specialists in a unique state-of-the art centre. The aim of the new centre is to accelerate research progress, conduct more clinical trials and save more lives from cancer. Find out more about it at www.southampton.ac.uk/youreit