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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: AstraZeneca • ClinicalTrials.gov ID: NCT06549595

Registry updated: 2026-09-21
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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.

Interventions

  • Surovatamig (Drug)
    a fully human bispecific monoclonal IgG4 antibody
  • R-CHOP (Drug)
    Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
  • R-CVP (Drug)
    Rituximab, Cyclophosphamide, Vincristine and Prednisone
  • BR (Drug)
    Bendamustine, Rituximab

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

Conditions

Untreated Follicular Lymphoma

Locations

  • Research Site — Huntsville, Alabama, United States
  • Research Site — Anchorage, Alaska, United States
  • Research Site — Phoenix, Arizona, United States
  • Research Site — Clovis, California, United States
  • Research Site — Los Alamitos, California, United States
  • Research Site — San Diego, California, United States
  • Research Site — Santa Monica, California, United States
  • Research Site — Aurora, Colorado, United States
  • Research Site — New Haven, Connecticut, United States
  • Research Site — Newark, Delaware, United States
  • Research Site — Jacksonville, Florida, United States
  • Research Site — Atlanta, Georgia, United States
  • Research Site — Macon, Georgia, United States
  • Research Site — Evanston, Illinois, United States
  • Research Site — Peoria, Illinois, United States
  • Research Site — Fort Wayne, Indiana, United States
  • Research Site — Des Moines, Iowa, United States
  • Research Site — Iowa City, Iowa, United States
  • Research Site — Lexington, Kentucky, United States
  • Research Site — Louisville, Kentucky, United States
  • Research Site — Baton Rouge, Louisiana, United States
  • Research Site — Baltimore, Maryland, United States
  • Research Site — Bethesda, Maryland, United States
  • Research Site — Columbia, Maryland, United States
  • Research Site — Boston, Massachusetts, United States
  • Research Site — Boston, Massachusetts, United States
  • 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 — Chesterfield, Missouri, United States
  • Research Site — Springfield, Missouri, United States
  • Research Site — Hackensack, New Jersey, United States
  • Research Site — New Brunswick, New Jersey, 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 — Charlotte, North Carolina, United States
  • Research Site — Wilmington, North Carolina, United States
  • Research Site — Winston-Salem, North Carolina, United States
  • Research Site — Blue Ash, Ohio, United States
  • Research Site — Cincinnati, Ohio, United States
  • Research Site — Columbus, Ohio, United States
  • Research Site — Eugene, Oregon, United States
  • Research Site — Portland, Oregon, United States
  • Research Site — Pittsburgh, Pennsylvania, United States
  • Research Site — Nashville, Tennessee, United States
  • Research Site — Austin, Texas, United States
  • Research Site — Lubbock, Texas, United States
  • Research Site — Shenandoah, Texas, United States
  • Research Site — Tyler, Texas, United States
  • Research Site — Salt Lake City, Utah, United States
  • Research Site — Fairfax, Virginia, United States
  • Research Site — Richmond, Virginia, United States
  • Research Site — Tacoma, Washington, United States
  • Research Site — Madison, Wisconsin, United States
  • Research Site — Milwaukee, Wisconsin, United States
  • Research Site — Clayton, Australia
  • Research Site — Darlinghurst, Australia
  • Research Site — Garran, Australia
  • Research Site — Heidelberg, Australia
  • Research Site — Macquarie University, Australia
  • Research Site — Nedlands, Australia
  • Research Site — Brussels, Belgium
  • Research Site — Brussels, Belgium
  • Research Site — Ghent, Belgium
  • Research Site — Mechelen, Belgium
  • Research Site — Porto Alegre, Brazil
  • Research Site — São Paulo, Brazil
  • Research Site — São Paulo, Brazil
  • 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
  • Research Site — Beijing, China
  • Research Site — Beijing, China
  • Research Site — Beijing, China
  • Research Site — Changchun, China
  • Research Site — Changsha, China
  • Research Site — Chengdu, China
  • Research Site — Chongqing, China
  • Research Site — Fuzhou, China
  • Research Site — Guangzhou, China
  • Research Site — Guangzhou, China
  • Research Site — Guangzhou, China
  • Research Site — Hangzhou, China
  • Research Site — Hangzhou, China
  • Research Site — Harbin, China
  • Research Site — Hefei, China
  • Research Site — Lanzhou, China
  • Research Site — Nanchang, China
  • Research Site — Nanchang, China
  • Research Site — Nanjing, China
  • Research Site — Nanning, China
  • Research Site — Shandong, China
  • Research Site — Shanghai, China
  • Research Site — Shanghai, China
  • Research Site — Shenyang, China
  • Research Site — Shenyang, China
  • Research Site — Shijiazhuang, China
  • Research Site — Suzhou, China
  • Research Site — Tianjin, China
  • Research Site — Wenzhou, China
  • Research Site — Wuhan, China
  • Research Site — Xi'an, China
  • Research Site — Xiamen, China
  • Research Site — Zhengzhou, China
  • Research Site — Zhengzhou, China
  • Research Site — Brno, Czechia
  • Research Site — Hradec Králové, Czechia
  • Research Site — Prague, Czechia
  • Research Site — Aalborg, Denmark
  • Research Site — Copenhagen, Denmark
  • Research Site — Odense C, Denmark
  • Research Site — Roskilde, Denmark
  • Research Site — Helsinki, Finland
  • Research Site — Kuopio, Finland
  • Research Site — Tampere, Finland
  • Research Site — Bayonne, France
  • Research Site — Lille, France
  • Research Site — Montpellier, France
  • Research Site — Saint-Cloud, France
  • Research Site — Vandœuvre-lès-Nancy, France
  • Research Site — Berlin, Germany
  • Research Site — Berlin, Germany
  • Research Site — Deggendorf, Germany
  • Research Site — Düsseldorf, Germany
  • Research Site — Göttingen, Germany
  • Research Site — Hamburg, Germany
  • Research Site — Heidelberg, Germany
  • Research Site — Jena, Germany
  • Research Site — Karlsruhe, Germany
  • Research Site — Kiel, Germany
  • Research Site — Lübeck, Germany
  • Research Site — Magdeburg, Germany
  • Research Site — Minden, Germany
  • Research Site — Münster, Germany
  • Research Site — Regensburgs, Germany
  • Research Site — Würzburg, Germany
  • Research Site — Hong Kong, Hong Kong
  • Research Site — Budapest, Hungary
  • Research Site — Budapest, Hungary
  • Research Site — Debrecen, Hungary
  • Research Site — Győr, Hungary
  • Research Site — Kaposvár, Hungary
  • Research Site — Nyíregyháza, Hungary
  • Research Site — Pécs, Hungary
  • Research Site — Szeged, Hungary
  • Research Site — Delhi, India
  • Research Site — Delhi, India
  • Research Site — Gurugram, India
  • Research Site — Kolkata, India
  • Research Site — Nashik, India
  • Research Site — Surat, India
  • Research Site — Thiruvananthapuram, India
  • Research Site — Bunkyō City, Japan
  • Research Site — Chiba, Japan
  • Research Site — Chuo-shi, Japan
  • Research Site — Fukuoka, Japan
  • Research Site — Hirakata-shi, Japan
  • Research Site — Kobe, Japan
  • Research Site — Kōtoku, Japan
  • Research Site — Kumamoto, Japan
  • Research Site — Kurashiki-shi, Japan
  • Research Site — Kyoto, Japan
  • Research Site — Minatoku, Japan
  • Research Site — Okayama, Japan
  • Research Site — Osaka, Japan
  • Research Site — Sapporo, Japan
  • Research Site — Sapporo, Japan
  • Research Site — Sunto-gun, Japan
  • Research Site — Toyoake-shi, Japan
  • Research Site — Yamagata, Japan
  • Research Site — Yokohama, Japan
  • Research Site — Gdansk, Poland
  • Research Site — Gliwice, Poland
  • Research Site — Katowice, Poland
  • Research Site — Krakow, Poland
  • Research Site — Lublin, Poland
  • Research Site — Lublin, Poland
  • Research Site — Warsaw, Poland
  • Research Site — Wroclaw, Poland
  • Research Site — Wroclaw, Poland
  • Research Site — San Juan, Puerto Rico
  • Research Site — Busan, South Korea
  • Research Site — Busan, South Korea
  • Research Site — Goyang-si, South Korea
  • Research Site — Jeonnam, South Korea
  • Research Site — Seoul, South Korea
  • Research Site — Seoul, South Korea
  • Research Site — Seoul, South Korea
  • Research Site — Seoul, South Korea
  • Research Site — Seoul, South Korea
  • Research Site — Barcelona, Spain
  • Research Site — Barcelona, Spain
  • Research Site — El Palmar, Spain
  • Research Site — Girona, Spain
  • Research Site — Las Palmas de Gran Canaria, Spain
  • Research Site — Madrid, Spain
  • Research Site — Madrid, Spain
  • Research Site — Oviedo, Spain
  • Research Site — Pamplona, Spain
  • Research Site — Santander, Spain
  • Research Site — Falun, Sweden
  • Research Site — Uppsala, Sweden
  • Research Site — Changhua, Taiwan
  • Research Site — Kaohsiung City, Taiwan
  • Research Site — Kaohsiung City, Taiwan
  • Research Site — Lukang Township, Taiwan
  • Research Site — Tainan, Taiwan
  • Research Site — Taipei, Taiwan
  • Research Site — Bangkok, Thailand
  • Research Site — Bangkok, Thailand
  • Research Site — Chiang Mai, Thailand
  • Research Site — Khon Kaen, Thailand
  • Research Site — Ankara, Turkey (Türkiye)
  • Research Site — Ankara, Turkey (Türkiye)
  • Research Site — Istanbul, Turkey (Türkiye)
  • Research Site — Istanbul, Turkey (Türkiye)
  • Research Site — Izmir, Turkey (Türkiye)
  • Research Site — London, United Kingdom
  • Research Site — London, United Kingdom
  • Research Site — Newcastle upon Tyne, United Kingdom
  • Research Site — Norwich, United Kingdom
  • Research Site — Nottingham, United Kingdom
  • Research Site — Plymouth, United Kingdom
  • Research Site — Southampton, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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