A Phase II Study Evaluating the Safety and Efficacy of Glofitamab in Combination with Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients with Untreated Diffuse Large B-Cell Lymphoma
Diffuse large B-cell lymphoma is an aggressive type of blood cancer affecting white blood cells. The standard first treatment is a combination of medicines called R-CHOP. While this helps many people, some patients have a higher risk of the lymphoma returning. Doctors can identify these patients using blood tests that detect tiny traces of tumour DNA. This Phase II clinical trial looks at whether adding an immunotherapy medicine called glofitamab to standard R-CHOP improves results for adults with newly diagnosed, higher-risk lymphoma. Glofitamab works by helping the body's immune cells find and destroy cancer cells. The trial also uses a medicine called RoActemra to help manage possible immune-related side effects. Researchers will track how well the cancer responds, overall safety, and how long patients stay free of disease.
At a glance
What is this study about?
Diffuse large B-cell lymphoma (DLBCL) is a fast-growing cancer that starts in the lymphatic system, an important part of your body's immune defences. The usual first treatment is a combination of targeted drugs, chemotherapy, and steroids known as R-CHOP. For many people, R-CHOP works well, but for others, the cancer may not completely clear or it may return later. Doctors can now use sensitive blood tests to find tiny pieces of tumour genetic material, called circulating tumour DNA. Patients with higher levels of this DNA in their blood have a greater risk of the cancer coming back.
In this study, researchers are testing whether adding a newer medicine called glofitamab to standard R-CHOP helps clear the lymphoma more effectively. Glofitamab is a specialised antibody designed to act like a bridge. It grabs onto lymphoma cells with one side and healthy immune cells with the other, bringing them close together so the immune system can destroy the cancer.
The trial also checks how safe this combination is and how well patients tolerate it. Because glofitamab strongly activates the immune system, it can sometimes cause fever or inflammation. The trial includes a treatment called RoActemra, which doctors can use to quickly calm these immune reactions if they occur. By testing this approach, doctors hope to improve initial treatment and give people with higher-risk lymphoma the best chance of long-term recovery.
Key takeaways
- Tests adding the immunotherapy medicine glofitamab to standard R-CHOP chemotherapy.
- Designed for adults aged 18 and over with newly diagnosed diffuse large B-cell lymphoma.
- Aimed specifically at patients identified as higher risk using specialised blood tests.
- Medicines are given by drip in hospital over about 4 to 6 months.
- Participation is entirely voluntary, with close monitoring by specialist cancer teams throughout.
Who may be eligible?
This trial is open to adults aged 18 and over who have been newly diagnosed with diffuse large B-cell lymphoma (DLBCL) and have not yet received any cancer treatment for it.
To be considered, your medical team will perform a blood test to check for circulating tumour DNA. Only patients whose test results show that their lymphoma is in a higher-risk group can take part.
You may not be eligible if you have already started chemotherapy, if your lymphoma has spread to the brain or spinal cord, or if you have serious underlying health conditions affecting your heart, liver, or kidneys. Your study doctor will carry out detailed health checks to make sure the trial is safe for you.
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 aged 18 or older.
- You have a confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL).
- You have not yet received treatment for your lymphoma.
- A blood test confirms high levels of circulating tumour DNA.
- You are well enough to cope with chemotherapy and regular hospital visits.
What does participation involve?
If you take part, you will receive treatment at a hospital cancer centre. You will be given standard R-CHOP chemotherapy alongside the study medicine, glofitamab, through a drip into a vein. Treatment is given in repeating cycles over roughly 4 to 6 months. Because glofitamab can cause immune reactions when first given, you may need close monitoring or a brief hospital stay during your early doses. Throughout the study, you will have regular blood tests, physical examinations, and scans (such as PET-CT scans) to see how the cancer is responding. After treatment ends, your care team will continue to check on your health with routine follow-up visits for several years.
Potential risks and benefits
Locations (5)
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Common questions
What is glofitamab and how does it work?
Glofitamab is an immunotherapy drug. It connects your body's infection-fighting immune cells directly to cancer cells, helping your immune system attack and destroy the lymphoma.
Will I definitely receive the study drug?
Yes. In this Phase II study, all participants who join receive glofitamab combined with standard R-CHOP chemotherapy.
What does 'high-risk' mean in this trial?
It means a specialised blood test found higher levels of tumour DNA, which suggests the lymphoma might be more stubborn and less likely to stay away with standard chemotherapy alone.
How often will I need to visit the hospital?
You will need to visit the hospital frequently during each treatment cycle for infusions, blood tests, and scans. Some early visits may require an overnight stay for observation.
Can I leave the study if I change my mind?
Yes. You have the right to withdraw from the study at any point. Your medical team will discuss standard treatment options with you, and your normal care will continue.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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