Study of AZD0486 plus rituximab versus standard chemotherapy drug combination in previously untreated follicular lymphoma patients

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What is this study about?

Follicular Lymphoma is a type of blood cancer that starts in immune cells called B‑cells. One common treatment for this disease uses a medicine called rituximab, which is given through a vein (intravenous) and helps the immune system recognize and kill cancer cells. In this study, participants receive the experimental drug Surovatamig, a laboratory‑made antibody that also targets cancer‑related proteins, together with rituximab. The standard treatment used for comparison includes a combination of chemotherapy drugs given through a vein: vinorelbine, doxorubicin, prednisone, bendamustine and cyclophosphamide. Chemotherapy uses strong medicines that stop cancer cells from growing.

The purpose is to compare the safety and effectiveness of Surovatamig plus rituximab with the standard chemotherapy plus rituximab in people who have not been treated for Follicular Lymphoma. The study begins with a short safety phase to find a suitable dose, followed by a larger phase where participants receive treatment cycles over several months. Throughout the trial, regular doctor visits, blood tests and imaging scans are performed to watch for side effects and to see how the disease responds.

1 baseline evaluation

after joining the study, you will undergo a physical exam, blood tests, and imaging scans to document the status of your follicular lymphoma. the results create a reference point for later comparisons.

2 safety run‑in dosing

you will receive an intravenous infusion of rituximab together with either the investigational drug azd0486 (test arm) or a combination of standard chemotherapy drugs (vincristine, doxorubicin, bendamustine, cyclophosphamide) (comparator arm). each medication is given by infusion as described in the study protocol. in addition, you will take an oral tablet of prednisone each day. the exact amount and schedule are defined by the trial protocol and are intended to evaluate safety and tolerability.

3 treatment cycles

the infusion of rituximab and the assigned study drug(s) will be repeated in multiple cycles, typically every few weeks, for the duration specified in the protocol. oral prednisone will be continued as directed during each cycle. the number of cycles continues until the end of the induction phase or until the study doctor decides to stop treatment because of side effects or disease response.

4 end of induction assessment

after the planned number of cycles, you will have a repeat set of scans and laboratory tests to determine the objective response rate. this evaluation compares the disease status after treatment with the baseline measurements taken at the start of the trial.

5 long‑term follow‑up

following the end of induction, you will return for regular visits to monitor for disease progression, overall survival, and any late side effects. these visits may include physical exams, blood work, and imaging at intervals defined by the study schedule.

Who Can Join the Study?

You must be at least 18 years old when you sign the informed consent form.
You need a diagnosis of classic follicular lymphoma that has been confirmed by looking at tissue under a microscope according to the World Health Organization (WHO) 2022 guidelines.
Your disease must be at stage II, III, or IV (meaning it has spread beyond the first lymph nodes) and have a FLIPI score between 2 and 5 (a number that helps doctors estimate how aggressive the lymphoma is).
Your overall health should allow you to do daily activities with an ECOG performance status of 0, 1, or 2 (a scale where 0 = fully active and 2 = able to care for yourself but unable to work).
You must not have received any prior treatment for follicular lymphoma, and your doctor must decide that you need overall therapy because you meet at least one GELF criterion (a set of signs that show the lymphoma is causing problems and needs treatment).
Your cancer must show up on a special scan called an FDG‑PET scan (the tumor takes up a sugar‑based tracer) and be measurable (doctors can see and measure its size).
You need to have adequate liver, blood (hematological), kidney (renal), and heart (cardiac) function, meaning lab tests show these organs are working well enough for the study medicines.

Who Cannot Join the Study?

Having a type of lymphoma called Follicular large B‑cell lymphoma (a specific classification) or a suspicion that the disease has changed into a more aggressive form, known as histologic transformation to a high‑grade or aggressive lymphoma.
Having a medical reason that makes any of the medicines used in the study (the B‑R, R‑CVP, or R‑CHOP combinations) or the study drug Surovatamig unsafe to use. This is called a contraindication, meaning a condition that prevents the use of a drug.
Having or having had lymphoma in the brain or spinal cord, called CNS lymphoma (CNS stands for central nervous system).
Having more than 5,000 lymphoma cells circulating in the blood, meaning cancer cells are present in the bloodstream at a high level.
Having an active or uncontrolled infection that requires treatment throughout the whole body (systemic therapy) and would put the person at high risk if they joined the study.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Region Sjaelland	Holbæk	Denmark
Odense University Hospital	Odense	Denmark
Aalborg University Hospital	Aalborg	Denmark
Rigshospitalet	Copenhagen	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not yet recruiting	30.09.2026

Trial locations

Investigated Drugs:

Rituximab is a medicine that targets a protein called CD20 on the surface of certain white blood cells. By binding to CD20, it helps the immune system recognize and destroy these cells. In this study, rituximab is given through an IV and is used in both the new treatment group and the standard‑treatment group to see how well it works together with other drugs.

Vincristine is a chemotherapy drug that stops cancer cells from dividing. It is given by IV and is part of the standard chemotherapy regimen used as the comparison treatment in the trial.

Doxorubicin is another chemotherapy medicine that works by damaging the DNA of cancer cells, which stops them from growing. It is also given intravenously and is included in the standard treatment arm of the study.

Prednisolone is a steroid taken by mouth that reduces inflammation and can help kill certain cancer cells. In the trial, it is used together with the other chemotherapy drugs in the standard‑treatment group.

AZD0486 is an experimental antibody that targets two proteins, CD3 and CD19, on immune cells. It is given as an IV infusion and is being tested in combination with rituximab to see if this new pairing works better than the usual chemotherapy plus rituximab.

Bendamustine is a chemotherapy drug that interferes with the DNA of cancer cells, preventing them from multiplying. It is administered intravenously and is part of the standard chemotherapy regimen used as the comparator in the study.

Cyclophosphamide is a chemotherapy agent that damages the DNA of rapidly growing cells, including cancer cells. It is given by IV and is also included in the standard‑treatment combination that the new therapy is being compared against.

Investigated Diseases:

Follicular lymphoma

Follicular lymphoma – Follicular lymphoma is a slow‑growing cancer of B‑cell lymphocytes that typically begins in the lymph nodes. It forms characteristic follicle‑like clusters of malignant cells and can spread to the bone marrow, spleen, and blood. The disease often progresses gradually over years, with periods of stable disease followed by slow increases in tumor size. In some patients the lymphoma may change into a faster‑growing form that behaves more aggressively.

Trial ID:

2023-510098-33-01

Protocol code:

D7401C00001

NCT ID:

NCT06549595

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of AZD0486 plus rituximab versus standard chemotherapy drug combination in previously untreated follicular lymphoma patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?