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.
Key facts
- Who runs it
- AstraZeneca
- Where
- Albany, Anchorage, Ann Arbor, Atlanta, Aurora, Austin, Baltimore, Baton Rouge, Bethesda, Blue Ash, Boston, Brooklyn, Charlotte, Chesterfield, Cincinnati, Clovis, Columbia, Columbus, Des Moines, Detroit, Eugene, Evanston, Fairfax, Fort Wayne, Hackensack, Huntsville, Iowa City, Jacksonville, Lexington, Los Alamitos, Louisville, Lubbock, Macon, Madison, Milwaukee, Mineola, Nashville, New Brunswick, New Haven, New Hyde Park, New York, Newark, Peoria, Phoenix, Pittsburgh, Portland, Richmond, Rochester, Saint Paul, Salt Lake City, San Diego, Santa Monica, Shenandoah, Springfield, Tacoma, Tyler, Wilmington, Winston-Salem, and Ypsilanti, United StatesSee the 59 sitesAlso in 24 other countries, 158 sites
- Trial code
- NCT06549595
- EU 2023-510098-33-01
- 2023-510098-33-00
- Registry title
- A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 1,018 people, planned
- Started
- 7 Aug 2024
- Expected to end
- 26 Nov 2031
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Surovatamig
- R-CHOP
- R-CVP
- BR
- Record updated
- 21 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with follicular lymphoma who have not yet had any treatment for it and now need treatment.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Classic follicular lymphoma confirmed by tissue examination. Stage II to IV, FLIPI score 2 to 5. Disease that shows up on FDG scans and can be measured. Needs treatment and meets at least 1 GELF criterion.
- Earlier treatment
- No earlier systemic treatment directed at the lymphoma.
Main reasons for not taking part
- Follicular large B-cell lymphoma (formerly grade 3B) or suspected change into a more aggressive lymphoma
- Lymphoma in the central nervous system now or in the past
- More than 5000 lymphoma cells circulating in the blood
- Active or uncontrolled infection that needs systemic treatment
- Known history of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS)
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
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?
Where in United States
Also in 24 other countries, 158 sites
- Albany, New YorkHospital not named in the registryTaking people
- Anchorage, AlaskaHospital not named in the registryTaking people
- Ann Arbor, MichiganHospital not named in the registryNot yet recruiting
- Atlanta, GeorgiaHospital not named in the registryNot yet recruiting
- Aurora, ColoradoHospital not named in the registryNo longer taking part
- Austin, TexasHospital not named in the registryNot yet recruiting
- Baltimore, MarylandHospital not named in the registryNot yet recruiting
- Baton Rouge, LouisianaHospital not named in the registryNot yet recruiting
- Bethesda, MarylandHospital not named in the registryTaking people
- Blue Ash, OhioHospital not named in the registryNot yet recruiting
- Boston, MassachusettsHospital not named in the registryNot yet recruiting
- Brooklyn, New YorkHospital not named in the registryNot yet recruiting
- Charlotte, North CarolinaHospital not named in the registryNot yet recruiting
- Chesterfield, MissouriHospital not named in the registryNot yet recruiting
- Cincinnati, OhioHospital not named in the registryNot yet recruiting
- Clovis, CaliforniaHospital not named in the registryNot yet recruiting
- Columbia, MissouriHospital not named in the registryNot yet recruiting
- Columbus, OhioHospital not named in the registryNot yet recruiting
- Des Moines, IowaHospital not named in the registryNot yet recruiting
- Detroit, MichiganHospital not named in the registryNo longer taking part
- Eugene, OregonHospital not named in the registryNot yet recruiting
- Evanston, IllinoisHospital not named in the registryNot yet recruiting
- Fairfax, VirginiaHospital not named in the registryNot yet recruiting
- Fort Wayne, IndianaHospital not named in the registryTaking people
- Hackensack, New JerseyHospital not named in the registryNot yet recruiting
- Huntsville, TexasHospital not named in the registryTaking people
- Iowa City, IowaHospital not named in the registryNot yet recruiting
- Jacksonville, FloridaHospital not named in the registryTaking people
- Lexington, KentuckyHospital not named in the registryNot yet recruiting
- Los Alamitos, CaliforniaHospital not named in the registryTaking people
- Louisville, KentuckyHospital not named in the registryNot yet recruiting
- Lubbock, TexasHospital not named in the registryNot yet recruiting
- Macon, GeorgiaHospital not named in the registryTaking people
- Madison, WisconsinHospital not named in the registryNot yet recruiting
- Milwaukee, WisconsinHospital not named in the registryNot yet recruiting
- Mineola, New YorkHospital not named in the registryNot yet recruiting
- Nashville, TennesseeHospital not named in the registryTaking people
- New Brunswick, New JerseyHospital not named in the registryNot yet recruiting
- New Haven, ConnecticutHospital not named in the registryTaking people
- New Hyde Park, New YorkHospital not named in the registryNot yet recruiting
- New YorkHospital not named in the registryTaking people
- Newark, DelawareHospital not named in the registryNot yet recruiting
- Peoria, IllinoisHospital not named in the registryNot yet recruiting
- Phoenix, ArizonaHospital not named in the registryTaking people
- Pittsburgh, PennsylvaniaHospital not named in the registryNot yet recruiting
- Portland, OregonHospital not named in the registryNo longer taking part
- Richmond, VirginiaHospital not named in the registryNot yet recruiting
- Rochester, MinnesotaHospital not named in the registryTaking people
- Saint Paul, MinnesotaHospital not named in the registryNot yet recruiting
- Salt Lake City, UtahHospital not named in the registryNot yet recruiting
- San Diego, CaliforniaHospital not named in the registryNot yet recruiting
- Santa Monica, CaliforniaHospital not named in the registryNot yet recruiting
- Shenandoah, TexasHospital not named in the registryNot yet recruiting
- Springfield, MissouriHospital not named in the registryTaking people
- Tacoma, WashingtonHospital not named in the registryTaking people
- Tyler, TexasHospital not named in the registryNot yet recruiting
- Wilmington, North CarolinaHospital not named in the registryNot yet recruiting
- Winston-Salem, North CarolinaHospital not named in the registryNot yet recruiting
- Ypsilanti, MichiganHospital not named in the registryNot yet recruiting
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- Rituximab, Surovatamig - ATreatment being tested
Surovatamig regimen A plus rituximab
Treatment: Surovatamig
- Rituximab, Surovatamig - BTreatment being tested
Surovatamig regimen B plus rituximab
Treatment: Surovatamig
- ChemoimmunotherapyExisting treatment, for comparison
Investigator's choice between 3 standard immunochemotherapy regimen (R-CHOP, R-CVP, or B-R followed by rituximab maintenance)
Treatment: R-CHOP, R-CVP, and BR
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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)
- Plain-language title
- Tests surovatamig with rituximab against standard chemotherapy for untreated follicular lymphomaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06549595, who can take part
- Record updated
- 21 October 2026