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

Recruiting now · Phase 3

Conditions studied: Untreated Follicular Lymphoma

In brief

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.

Key facts

Study ID: NCT06549595
Run by: AstraZeneca
People needed: 1018
Starts: 2024-08-07
Expected to finish: 2031-11-26
Last updated by the study team: 2026-07-20

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 investigator 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 criteria details may apply

Where it is running

Research Site — Montreal, Quebec, Canada (enrolling)
Research Site — Chongqing, China (enrolling)
Research Site — São Paulo, Brazil (enrolling)
Research Site — Chicoutimi, Quebec, Canada (enrolling)
Research Site — Beijing, China (enrolling)
Research Site — Chengdu, China (enrolling)
Research Site — Heidelberg, Australia (enrolling)
Research Site — Porto Alegre, Brazil (enrolling)
Research Site — Halifax, Nova Scotia, Canada (enrolling)
Research Site — Toronto, Ontario, Canada (enrolling)
Research Site — Beijing, China (enrolling)
Research Site — Beijing, China (enrolling)
Research Site — Changchun, China (enrolling)
Research Site — Changsha, China (enrolling)
Research Site — Anchorage, Alaska, United States (enrolling)
Research Site — Garran, Australia (enrolling)
Research Site — Macquarie University, Australia (enrolling)
Research Site — Nedlands, Australia (enrolling)
Research Site — São Paulo, Brazil (enrolling)
Research Site — Winnipeg, Manitoba, Canada (enrolling)
Research Site — Hamilton, Ontario, Canada (enrolling)
Research Site — Oshawa, Ontario, Canada (enrolling)
Research Site — Québec, Quebec, Canada (enrolling)
Research Site — Saint-Jérôme, Quebec, Canada (enrolling)
Research Site — Fuzhou, China (enrolling)

Full record on ClinicalTrials.gov

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