🔎 Trials Near Me

Home › Follicular Lymphoma › NCT06549595

A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients

RecruitingPhase 3

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)

Who can join

Ages 18 to 130 · All sexes

Full eligibility criteria
Inclusion Criteria:

1. Participant must be at least 18 years of age, inclusive, at the time of signing the ICF.
2. Histologically confirmed diagnosis of classic FL per WHO 2022 classification
3. ECOG performance status of 0 to 2
4. No prior systemic lymphoma-directed therapy
5. Need for systemic treatment meeting at least 1 GELF criteria
6. FDG-avid and measurable disease
7. Stage II to IV and FLIPI 2-5 \[Phase III only\]
8. Adequate liver, hematological, renal and cardiac function.

The above is a summary, other inclusion criteria details may apply

Exclusion Criteria:

1. 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
2. Contra-indication to BR, RCVP, and R-CHOP
3. Participants with or history of CNS lymphoma
4. 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
5. Presence of \>5000 circulating lymphoma cells
6. 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
7. Known history of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS)

The above is a summary, other exclusion criteria details may apply

About the study

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.

What is being tested

Sponsor: AstraZeneca · Participants: 1,018 · Started: Aug 7, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06549595

Locations in the U.S.

AlabamaResearch Site, Huntsville
AlaskaResearch Site, Anchorage
ArizonaResearch Site, Phoenix (Not yet recruiting)
CaliforniaResearch Site, Clovis (Not yet recruiting)
Research Site, Los Alamitos
Research Site, San Diego (Not yet recruiting)
Research Site, Santa Monica (Not yet recruiting)
ConnecticutResearch Site, New Haven
DelawareResearch Site, Newark (Not yet recruiting)
FloridaResearch Site, Jacksonville (Not yet recruiting)
GeorgiaResearch Site, Atlanta (Not yet recruiting)
Research Site, Macon
IllinoisResearch Site, Evanston (Not yet recruiting)
Research Site, Peoria (Not yet recruiting)
IndianaResearch Site, Fort Wayne
IowaResearch Site, Des Moines (Not yet recruiting)
Research Site, Iowa City (Not yet recruiting)
KentuckyResearch Site, Lexington (Not yet recruiting)
Research Site, Louisville (Not yet recruiting)
LouisianaResearch Site, Baton Rouge (Not yet recruiting)
MarylandResearch Site, Baltimore (Not yet recruiting)
Research Site, Bethesda
Research Site, Columbia (Not yet recruiting)
MassachusettsResearch Site, Boston (Not yet recruiting)
Research Site, Boston (Not yet recruiting)
MichiganResearch Site, Ann Arbor (Not yet recruiting)
Research Site, Ypsilanti (Not yet recruiting)
MinnesotaResearch Site, Saint Paul (Not yet recruiting)
MissouriResearch Site, Chesterfield (Not yet recruiting)
Research Site, Springfield
New JerseyResearch Site, Hackensack (Not yet recruiting)
Research Site, New Brunswick (Not yet recruiting)
New YorkResearch Site, Albany
Research Site, New Hyde Park (Not yet recruiting)
Research Site, New York
Research Site, New York (Not yet recruiting)
Research Site, New York
North CarolinaResearch Site, Charlotte (Not yet recruiting)
Research Site, Wilmington (Not yet recruiting)
Research Site, Winston-Salem (Not yet recruiting)
OhioResearch Site, Blue Ash (Not yet recruiting)
Research Site, Cincinnati (Not yet recruiting)
Research Site, Columbus (Not yet recruiting)
OregonResearch Site, Eugene (Not yet recruiting)
PennsylvaniaResearch Site, Pittsburgh (Not yet recruiting)
TennesseeResearch Site, Nashville (Not yet recruiting)
TexasResearch Site, Austin (Not yet recruiting)
Research Site, Lubbock (Not yet recruiting)
Research Site, Shenandoah (Not yet recruiting)
Research Site, Tyler (Not yet recruiting)
UtahResearch Site, Salt Lake City (Not yet recruiting)
VirginiaResearch Site, Fairfax (Not yet recruiting)
Research Site, Richmond (Not yet recruiting)
WashingtonResearch Site, Tacoma (Not yet recruiting)
WisconsinResearch Site, Madison (Not yet recruiting)
Research Site, Milwaukee (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.