RecruitingPhase 3NCT06549595

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)

Sponsor

AstraZeneca

Enrollment

1,018 participants

Start Date

Aug 7, 2024

Study Type

INTERVENTIONAL

Conditions

Untreated Follicular Lymphoma

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 130 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug combination — surovatamig (AZD0486) plus rituximab — for people with follicular lymphoma, a slow-growing type of non-Hodgkin's lymphoma (blood cancer), who have never received systemic treatment before. Surovatamig is a new type of immune therapy, and the trial is exploring whether adding it to rituximab (a widely used cancer antibody) improves outcomes. **You may be eligible if...** - You are 18 years of age or older - You have been confirmed to have follicular lymphoma (classic type, per WHO 2022 classification) - You have never received systemic treatment for lymphoma before - Your lymphoma has spread enough to require treatment (meeting specific disease burden criteria) - Your liver, kidney, blood, and heart function are adequate - You are in good physical condition (ECOG 0–2) **You may NOT be eligible if...** - Your lymphoma has transformed into a high-grade or aggressive form - You have had serious heart problems, active infections, or autoimmune conditions - You are pregnant or breastfeeding - You are unable to receive rituximab for medical reasons - You have active central nervous system involvement from lymphoma Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSurovatamig

a fully human bispecific monoclonal IgG4 antibody

DRUGR-CHOP

Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone

DRUGR-CVP

Rituximab, Cyclophosphamide, Vincristine and Prednisone

DRUGBR

Bendamustine, Rituximab

Locations(159)

Research Site

Anchorage, Alaska, United States

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Phoenix, Arizona, United States

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Clovis, California, United States

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Los Alamitos, California, United States

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San Diego, California, United States

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Santa Monica, California, United States

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Aurora, Colorado, United States

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New Haven, Connecticut, United States

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Jacksonville, Florida, United States

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Atlanta, Georgia, United States

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Macon, Georgia, United States

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Fort Wayne, Indiana, United States

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Des Moines, Iowa, United States

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Iowa City, Iowa, United States

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Louisville, Kentucky, United States

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Baltimore, Maryland, United States

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Bethesda, Maryland, United States

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Boston, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Detroit, Michigan, United States

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Ypsilanti, Michigan, United States

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Springfield, Missouri, United States

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New Brunswick, New Jersey, United States

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New Hyde Park, New York, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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Columbus, Ohio, United States

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Pittsburgh, Pennsylvania, United States

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Nashville, Tennessee, United States

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Tacoma, Washington, United States

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Madison, Wisconsin, United States

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Darlinghurst, Australia

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Garran, Australia

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Heidelberg, Australia

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Macquarie University, Australia

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Nedlands, Australia

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Brussels, Belgium

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Brussels, Belgium

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Ghent, Belgium

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Mechelen, Belgium

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Porto Alegre, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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Winnipeg, Manitoba, Canada

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Halifax, Nova Scotia, Canada

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Barrie, Ontario, Canada

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Hamilton, Ontario, Canada

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Oshawa, Ontario, Canada

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Toronto, Ontario, Canada

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Chicoutimi, Quebec, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Saint-Jérôme, Quebec, Canada

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Beijing, China

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Beijing, China

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Beijing, China

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Changchun, China

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Changsha, China

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Chengdu, China

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Chongqing, China

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Fuzhou, China

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Guangzhou, China

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Guangzhou, China

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Guangzhou, China

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Hangzhou, China

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Hangzhou, China

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Harbin, China

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Hefei, China

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Lanzhou, China

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Nanchang, China

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Nanchang, China

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Nanjing, China

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Nanning, China

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Shandong, China

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Shanghai, China

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Shanghai, China

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Shenyang, China

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Shenyang, China

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Shijiazhuang, China

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Suzhou, China

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Tianjin, China

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Wenzhou, China

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Wuhan, China

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Xi'an, China

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Xiamen, China

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Zhengzhou, China

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Zhengzhou, China

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Helsinki, Finland

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Kuopio, Finland

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Tampere, Finland

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Hong Kong, Hong Kong

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Shatin, Hong Kong

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Budapest, Hungary

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Delhi, India

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Delhi, India

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Gurugram, India

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Kolkata, India

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Nashik, India

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Surat, India

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Thiruvananthapuram, India

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Bunkyō City, Japan

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Chiba, Japan

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Chuo-shi, Japan

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Fukuoka, Japan

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Hirakata-shi, Japan

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Kobe, Japan

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Kōtoku, Japan

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Kumamoto, Japan

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Kurashiki-shi, Japan

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Kyoto, Japan

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Minatoku, Japan

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Okayama, Japan

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Osaka, Japan

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Sapporo, Japan

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Sapporo, Japan

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Sunto-gun, Japan

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Toyoake-shi, Japan

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Yamagata, Japan

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Yokohama, Japan

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Gliwice, Poland

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Busan, South Korea

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Busan, South Korea

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Goyang-si, South Korea

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Jeonnam, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Barcelona, Spain

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Barcelona, Spain

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El Palmar, Spain

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Girona, Spain

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Las Palmas de Gran Canaria, Spain

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Madrid, Spain

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Madrid, Spain

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Oviedo, Spain

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Pamplona, Spain

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Santander, Spain

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Falun, Sweden

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Uppsala, Sweden

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Changhua, Taiwan

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Kaohsiung City, Taiwan

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Kaohsiung City, Taiwan

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Lukang Township, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

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Bangkok, Thailand

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Bangkok, Thailand

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Chiang Mai, Thailand

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Khon Kaen, Thailand

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London, United Kingdom

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London, United Kingdom

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Newcastle upon Tyne, United Kingdom

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Norwich, United Kingdom

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Nottingham, United Kingdom

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Plymouth, United Kingdom

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Southampton, United Kingdom

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NCT06549595