Comparing 3 approaches for untreated follicular lymphoma
Official title: A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients
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)
Interventions
Surovatamig
a fully human bispecific monoclonal IgG4 antibody
R-CHOP
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
R-CVP
Rituximab, Cyclophosphamide, Vincristine and Prednisone
BR
Bendamustine, Rituximab
Canadian Sites (10)
Research Site
Winnipeg, Manitoba, Canada
Research Site
Halifax, Nova Scotia, Canada
Research Site
Barrie, Ontario, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
Oshawa, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Chicoutimi, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Saint-Jérôme, Quebec, Canada
Eligibility Criteria
See who this study is looking for17 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Stage II to IV and FLIPI 2-5 \[Phase IIIPhase 3A large study comparing a treatment against the current standard.Read more → only\]
- +Participant must be at least 18 years of age, inclusive, at the time of signing the ICFInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- +Histologically confirmed diagnosis of classic FL per WHO 2022 classification
- +No prior systemic lymphoma-directed therapy
- +Need for systemic treatment meeting at least 1 GELF criteria
- +FDG-avid and measurable disease
- +Adequate liver, hematological, renal and cardiac function.
- +The above is a summary, other inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → details may apply
- +ECOG performance status of 0 to 2
Exclusion
- −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
- −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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → considers to have the potential to interfere with the evaluation of safety
- −Presence of \>5000 circulating lymphoma cells
- −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
- −Known history of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS)
- −The above is a summary, other exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → details may apply
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: Surovatamig, R-CHOP, R-CVP, BR.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 3 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 18 years to 130 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 1,018 people.
The study is currently expected to finish around November 2031.
The main measurement is taken over: Up to 10 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
SRI Primary: Incidence, nature and severity of AEs and SAEs. Incidence and nature of study drug discontinuations, dose reductions, and dose delays due to AEs — measured over Up to 10 years.
SRI Primary: Determination of the recommended Phase IIIPhase 3A large study comparing a treatment against the current standard.Read more → dose (RP3D) — measured over Up to 1 year.
Phase 3 Dual Primary: To demonstrate the superiority of Surovatamig plus rituximab compared to InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s choice of SoCStandard of careThe treatment normally given for a condition outside a study.Read more → chemoimmunotherapy — measured over Up to 10 years.
Phase 3 Dual Primary: To demonstrate the superiority of Surovatamig plus rituximab compared to Investigator's choice of SoC chemoimmunotherapy — measured over Up to 10 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06549595 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About SurovatamigDrug
a fully human bispecific monoclonal IgG4 antibody
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About R-CHOPDrug
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About R-CVPDrug
Rituximab, Cyclophosphamide, Vincristine and Prednisone
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About BRDrug
Bendamustine, Rituximab
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 130 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 130 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to 10 years.
The study as a whole is currently expected to finish around 2031-11-26.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 1,018 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 18 locations, including: Winnipeg, Manitoba, Canada; Halifax, Nova Scotia, Canada; Barrie, Ontario, Canada; Hamilton, Ontario, Canada; Oshawa, Ontario, Canada; Toronto, Ontario, Canada, and 12 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (10)
Research Site
Ann Arbor, Michigan, United States
Research Site
Detroit, Michigan, United States
Research Site
Ypsilanti, Michigan, United States
Research Site
Saint Paul, Minnesota, United States
Research Site
Albany, New York, United States
Research Site
New Hyde Park, New York, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
Research Site
Tacoma, Washington, United States
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.