Tests surovatamig with rituximab against standard chemotherapy for untreated follicular lymphoma
Compares surovatamig plus rituximab with standard chemotherapy plus rituximab in adults with untreated follicular lymphoma.
Plain-language title generated from the registry record
Registry title: A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients
Key facts
- Where
- Aalborg, Copenhagen Oe, Odense, and Roskilde, DenmarkSee the 4 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 130 years old?
Source: NCT06549595, who can take part
Where in Denmark
- Region NordjyllandAalborg, DenmarkTaking people
- RigshospitaletCopenhagen Oe, DenmarkTaking people
- Odense University HospitalOdense, DenmarkTaking people
- Region SjaellandRoskilde, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT06549595EU 2023-510098-33-01
- Record updated
- 21 October 2026
- Original description
This is a global, randomised, Phase III, multicentre, open-label study evaluating the efficacy, safety and the degree of added benefit of the Surovatamig (AZD0486) plus rituximab combination compared to Investigator's choice of 3 standard immunochemotherapy regimen, conducted in participants with untreated FL.Read full original descriptionShow less
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)
This is a global, randomised, Phase III, multicentre, open-label study evaluating the efficacy, safety and the degree of added benefit of the Surovatamig (AZD0486) plus rituximab combination compared to Investigator's choice of 3 standard immunochemotherapy regimen, conducted in participants with untreated FL.
Inclusion: Participant must be at least 18 years of age, inclusive, at the time of signing the ICF; Histologically confirmed diagnosis of classic FL per WHO 2022 classification; ECOG performance status of 0 to 2; No prior systemic lymphoma-directed therapy; Need for systemic treatment meeting at least 1 GELF criteria; FDG-avid and measurable disease; Stage II to IV and FLIPI 2-5 [Phase III only]; Adequate liver, hematological, renal and cardiac function; The above is a summary, other inclusion criteria details may apply.
Exclusion: Active or uncontrolled infection (including EBV) requiring systemic therapy and which places participant at unacceptable risk if he/she were to participate in the study. If a participant has a history of COVID-19 within 1 month of C1D1 or contracts COVID while on study treatment, participant must have 2 consecutive negative tests (PCR testing is preferable) performed at least 48 hours apart prior to resuming dosing. All symptoms related to COVID-19 infection should have fully resolved before initiating or resuming treatment; Participants with or history of CNS lymphoma; History of a clinically relevant CNS medical condition or pathology that required treatment in the preceding year, is currently symptomatic or that which the treating investigator considers to have the potential to interfere with the evaluation of safety; Known history of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS); The above is a summary, other exclusion criteria details may apply; Follicular large B-cell lymphoma (WHO 2022 classification), formerly Follicular lymphoma Grade 3B (WHO 2016 classification) or suspicion for histologic transformation to high-grade/aggressive lymphoma; Contra-indication to BR, RCVP, and R-CHOP; Presence of >5000 circulating lymphoma cells.