A Phase III, Multicentre, Randomised, Open-label Study to Compare the Efficacy and Safety of AZD0486 plus Rituximab versus Chemotherapy plus Rituximab in Previously Untreated Participants with Follicular Lymphoma (SOUNDTRACK-F1)
Follicular lymphoma is a slow-growing type of blood cancer affecting the lymphatic system. The usual first treatment is chemotherapy combined with an antibody drug called rituximab. While this works well for many, chemotherapy can cause tough side effects. The SOUNDTRACK-F1 study is testing a new drug called surovatamig (AZD0486) paired with rituximab. Surovatamig is designed to help your own immune system find and attack cancer cells without using traditional chemotherapy. In this study, doctors are comparing this new combination directly against standard chemotherapy plus rituximab in people who have not yet had any treatment for follicular lymphoma. The main goal is to find out if the new combination can control the cancer for longer and help people live well with fewer side effects.
At a glance
What is this study about?
Follicular lymphoma is a type of non-Hodgkin lymphoma. It develops when white blood cells called lymphocytes grow out of control, usually causing swollen lymph nodes in places like your neck, armpits, or groin. Because it is slow-growing, many people live with it for a long time, but it often needs treatment when symptoms appear or when the cancer spreads.
Currently, the standard first-line treatment in the UK is chemotherapy combined with an immunotherapy drug called rituximab. While standard chemoimmunotherapy can put the lymphoma into remission, chemotherapy medicines attack both healthy and cancerous cells, often leading to unpleasant side effects like fatigue, sickness, hair loss, and an increased risk of infections.
This clinical study, called SOUNDTRACK-F1, is investigating whether a new medicine called surovatamig (also known as AZD0486) can replace standard chemotherapy. Surovatamig is a specialised immune therapy designed to connect cancer cells directly to your body's immune cells so your body can fight the cancer naturally. Researchers hope this combination will be more effective and gentler on the body than standard chemotherapy.
Key takeaways
- Tests a new targeted immune drug (surovatamig) plus rituximab against standard chemotherapy.
- Open to adults aged 18 and over who have untreated follicular lymphoma.
- A phase 3 study comparing effectiveness and safety between two treatment approaches.
- Participants are placed into one of two groups by random selection.
- Participation is entirely voluntary and you can stop at any point.
Who may be eligible?
This trial is for adults aged 18 or older who have recently been diagnosed with follicular lymphoma and have not yet received any treatment for it. Because it is a first-line study, people who have already had chemotherapy or other major cancer therapies for their lymphoma will not be able to join.
Participants must have active lymphoma that doctors have decided requires treatment now, rather than just careful monitoring. You will also need to be reasonably active and well enough in your day-to-day life to attend hospital appointments and receive treatment safely.
Your study doctor will run routine health checks, including blood tests and scans, to make sure your heart, kidneys, and liver are working well enough for you to take part safely.
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.
- I am 18 years of age or older.
- I have been diagnosed with follicular lymphoma.
- I have not had any previous cancer treatment for this condition.
- My doctor has advised that my lymphoma needs treatment now.
- I am well enough to attend regular hospital appointments for treatment and tests.
What does participation involve?
If you take part, you will be placed into one of two treatment groups by chance (randomised). One group receives the new medicine (surovatamig) alongside rituximab. The other group receives standard chemotherapy (such as bendamustine or CHOP chemotherapy) alongside rituximab. You and your doctor will know which treatment you are receiving.
Treatments are given at the hospital through an intravenous drip into a vein. During the initial weeks, you may need to visit the hospital more frequently for careful observation, blood tests, and scans. As treatment continues, visits usually become less frequent.
Doctors will track your health using regular blood tests, physical checks, and imaging scans (such as CT or PET scans) to see how your lymphoma responds. After your treatment ends, you will have regular long-term follow-up visits so the medical team can monitor your health and recovery over several years.
Potential risks and benefits
Locations (6)
- —UnverifiedDenmark
- —UnverifiedCzechia
- —UnverifiedGermany
- —UnverifiedHungary
- —UnverifiedItaly
- —UnverifiedSpain
Common questions
What is follicular lymphoma?
It is a slow-growing type of blood cancer that affects white blood cells within the lymphatic system, which is part of your immune system.
Can I choose which treatment group I join?
No. A computer system places you into a group at random. This makes sure the study results are fair and reliable.
Will taking part cost me anything?
No. Study medicines and study-related tests are provided free of charge, and help with travel expenses is often available.
How is the new drug given?
Surovatamig is given as an infusion into a vein at the hospital under close supervision by your care team.
What happens if I change my mind?
You can leave the trial at any time for any reason. Your medical team will continue to support you with standard treatment options.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.