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A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients
NCT06549595 · AstraZeneca
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
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)
About this study
The study consists of 2 sequential parts.
1. Safety Run-in - this part will compare dose levels of Surovatamig (AZD0486) in combination with rituximab in order to establish the RP3D.
2. Phase III - The Phase III part will assess the superiority of Surovatamig (AZD0486) at RP3D in combination with rituximab, compared to Investigator's choice between 3 standard chemoimmunotherapy regimens. Phase 3 consists of 3 arms
1. Arm A: treatment with Surovatamig plus rituximab Schedule A
2. Arm B: treatment with Surovatamig plus rituximab Schedule B
3. Arm C (Comparator arm): one of the following standard regimens per Investigator's choice: R-CVP + rituximab maintenance, R-CHOP + rituximab maintenance or B-R + rituximab maintenance
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
Study design
Enrollment target: 1018 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-08-07
Estimated completion: 2031-11-26
Last updated: 2026-07-20
Interventions
Drug: SurovatamigDrug: R-CHOPDrug: R-CVPDrug: BR
Primary outcomes
- • 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 (Up to 10 years)
- • SRI Primary: Determination of the recommended Phase III dose (RP3D) (Up to 1 year)
- • Phase 3 Dual Primary: To demonstrate the superiority of Surovatamig plus rituximab compared to Investigator's choice of SoC chemoimmunotherapy (Up to 10 years)
Sponsor
AstraZeneca · industry
Contacts & investigators
ContactAstraZeneca Clinical Study Information Center · contact · information.center@astrazeneca.com · 1-877-240-9479
InvestigatorChan Cheah, MBBS FRACP FRCPA DMSc · principal_investigator, Sir Charles Gairdner Hospital (SCGH)
All locations (224)
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Huntsville, Alabama, United States
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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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Newark, Delaware, 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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Evanston, Illinois, United States
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Peoria, Illinois, 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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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Columbia, Maryland, United States
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Boston, Massachusetts, 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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Saint Paul, Minnesota, United States
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Springfield, Missouri, United States
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Hackensack, New Jersey, United States
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New Brunswick, New Jersey, United States
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Albany, New York, 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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Charlotte, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Blue Ash, Ohio, United States
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Columbus, Ohio, United States
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Eugene, Oregon, United States
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Pittsburgh, Pennsylvania, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Lubbock, Texas, United States
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Shenandoah, Texas, United States
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Tyler, Texas, United States
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Salt Lake City, Utah, United States
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Fairfax, Virginia, United States
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Richmond, Virginia, United States
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Tacoma, Washington, United States
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Clayton, Australia
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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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Brno, Czechia
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Hradec Králové, Czechia
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Prague, Czechia
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Aalborg, Denmark
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Copenhagen, Denmark
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Odense C, Denmark
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Roskilde, Denmark
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Helsinki, Finland
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Kuopio, Finland
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Tampere, Finland
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Berlin, Germany
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Berlin, Germany
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Deggendorf, Germany
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Düsseldorf, Germany
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Göttingen, Germany
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Heidelberg, Germany
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Jena, Germany
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Karlsruhe, Germany
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Kiel, Germany
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Lübeck, Germany
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Minden, Germany
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Münster, Germany
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Würzburg, Germany
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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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Budapest, Hungary
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Debrecen, Hungary
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Győr, Hungary
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Kaposvár, Hungary
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Nyíregyháza, Hungary
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Pécs, Hungary
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Szeged, 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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Gdansk, Poland
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Gliwice, Poland
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Katowice, Poland
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Krakow, Poland
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Lublin, Poland
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Lublin, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Wroclaw, Poland
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San Juan, Puerto Rico
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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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Ankara, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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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