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NCT06549595PHASE3Recruiting

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

AstraZeneca

Start Date

8/7/2024

Completion Date

11/26/2031

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.

Detailed Description

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

Age Range: 18 years to 130 years

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

Interventions

DRUG

Surovatamig

DRUG

R-CHOP

DRUG

R-CVP

DRUG

BR

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Conditions

Untreated Follicular Lymphoma

Locations

Research Site

Huntsville, Alabama 35805

United States

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Anchorage, Alaska 99508

United States

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Phoenix, Arizona 85054

United States

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Clovis, California 93611

United States

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Los Alamitos, California 90720

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San Diego, California 92121

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Santa Monica, California 90404

United States

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Aurora, Colorado 80045

United States

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New Haven, Connecticut 06510

United States

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Newark, Delaware 19713

United States

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Jacksonville, Florida 32224

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Atlanta, Georgia 30322

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Macon, Georgia 31201

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Evanston, Illinois 60201

United States

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Peoria, Illinois 61615

United States

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Fort Wayne, Indiana 46804

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Des Moines, Iowa 50309

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Iowa City, Iowa 52242

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Lexington, Kentucky 40536

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Louisville, Kentucky 40207

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Baton Rouge, Louisiana 70808

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Baltimore, Maryland 21201

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Bethesda, Maryland 20817

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Columbia, Maryland 21044

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Boston, Massachusetts 02114

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Boston, Massachusetts 02215

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Ann Arbor, Michigan 48109

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Detroit, Michigan 48201

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Ypsilanti, Michigan 48197

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Saint Paul, Minnesota 55102

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Springfield, Missouri 65807

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Hackensack, New Jersey 07601

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New Brunswick, New Jersey 08901

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Albany, New York 12206

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New Hyde Park, New York 11042

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New York, New York 10016

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New York, New York 10032

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New York, New York 10065

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Charlotte, North Carolina 28204

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Winston-Salem, North Carolina 27103

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Blue Ash, Ohio 45242

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Columbus, Ohio 43210

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Eugene, Oregon 97401

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Pittsburgh, Pennsylvania 15232

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Nashville, Tennessee 37203

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Austin, Texas 78705

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Lubbock, Texas 79430

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Shenandoah, Texas 77380

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Tyler, Texas 75702

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Salt Lake City, Utah 84112

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Fairfax, Virginia 22031

United States

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Richmond, Virginia 23219

United States

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Tacoma, Washington 98405

United States

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Madison, Wisconsin 53792

United States

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Milwaukee, Wisconsin 53226

United States

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Clayton, 3168

Australia

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Darlinghurst, 2010

Australia

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Garran, 2605

Australia

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Heidelberg, 3084

Australia

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Macquarie University, 2109

Australia

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Nedlands, 6009

Australia

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Brussels, 1070

Belgium

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Brussels, 1090

Belgium

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Ghent, 9000

Belgium

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Mechelen, 2800

Belgium

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Porto Alegre, 90035-003

Brazil

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São Paulo, 04501-000

Brazil

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São Paulo, 05652-900

Brazil

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Winnipeg, Manitoba R3E 0V9

Canada

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Halifax, Nova Scotia B3H 2Y9

Canada

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Barrie, Ontario L4M 6M2

Canada

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Hamilton, Ontario L8V 5C2

Canada

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Oshawa, Ontario L1G 2B9

Canada

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Toronto, Ontario M5G 1X6

Canada

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Chicoutimi, Quebec G7H 5H6

Canada

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Montreal, Quebec H4J 1C5

Canada

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Québec, Quebec G1J 1Z4

Canada

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Saint-Jérôme, Quebec J7Z 2V4

Canada

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Beijing, 100044

China

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Beijing, 100142

China

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Beijing, 100730

China

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Changchun, 130021

China

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Changsha, 410013

China

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Chengdu, 610078

China

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Chongqing, 400030

China

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Fuzhou, 350001

China

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Guangzhou, 510000

China

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Guangzhou, 510060

China

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Guangzhou, 510100

China

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Hangzhou, 310003

China

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Hangzhou, 310022

China

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Harbin, 150081

China

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Hefei, 230031

China

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Lanzhou, 730000

China

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Nanchang, 330006

China

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Nanchang, 330029

China

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Nanjing, 210029

China

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Nanning, 530021

China

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Shandong, 250117

China

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Shanghai, 200065

China

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Shanghai, 20032

China

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Shenyang, 110001

China

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Shenyang, 110004

China

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Shijiazhuang, 054001

China

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Suzhou, 215006

China

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Tianjin, 300020

China

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Wenzhou, 325000

China

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Wuhan, 430079

China

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Xi'an, 710114

China

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Xiamen, 361003

China

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Zhengzhou, 450000

China

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Zhengzhou, 450008

China

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Brno, 625 00

Czechia

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Hradec Králové, 500 05

Czechia

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Prague, 12808

Czechia

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Aalborg, 9100

Denmark

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Copenhagen, 2100

Denmark

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Odense C, 5000

Denmark

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Roskilde, 4000

Denmark

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Helsinki, 00029

Finland

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Kuopio, 70029

Finland

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Tampere, 33520

Finland

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Berlin, 10967

Germany

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Berlin, 13353

Germany

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Deggendorf, 94469

Germany

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Düsseldorf, 40479

Germany

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Göttingen, 37075

Germany

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Heidelberg, 69120

Germany

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Jena, 07747

Germany

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Karlsruhe, 76133

Germany

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Kiel, 24105

Germany

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Lübeck, 23538

Germany

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Minden, 32429

Germany

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Münster, 48129

Germany

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Würzburg, 97080

Germany

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Hong Kong, 999077

Hong Kong

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Shatin, 00000

Hong Kong

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Budapest, 1088

Hungary

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Budapest, 1122

Hungary

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Debrecen, 4032

Hungary

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Győr, 9024

Hungary

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Kaposvár, 7400

Hungary

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Nyíregyháza, 4400

Hungary

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Pécs, 7624

Hungary

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Szeged, 6725

Hungary

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Delhi, 110029

India

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Delhi, 110085

India

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Gurugram, 122002

India

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Kolkata, 700160

India

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Nashik, 422002

India

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Surat, 396007

India

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Thiruvananthapuram, 695011

India

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Bunkyō City, 113-8677

Japan

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Chiba, 260-8717

Japan

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Chuo-shi, 409-3898

Japan

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Fukuoka, 812-8582

Japan

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Hirakata-shi, 573-1191

Japan

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Kobe, 650-0047

Japan

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Kōtoku, 135-8550

Japan

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Kumamoto, 860-8556

Japan

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Kurashiki-shi, 710-8602

Japan

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Kyoto, 602-8566

Japan

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Minatoku, 105-8470

Japan

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Okayama, 700-8558

Japan

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Osaka, 541-8567

Japan

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Sapporo, 003-0006

Japan

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Sapporo, 060-8638

Japan

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Sunto-gun, 411-8777

Japan

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Toyoake-shi, 470-1192

Japan

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Yamagata, 990-9585

Japan

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Yokohama, 241-8515

Japan

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Gdansk, 80-214

Poland

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Gliwice, 44-102

Poland

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Katowice, 40-519

Poland

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Krakow, 30-727

Poland

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Lublin, 20-081

Poland

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Lublin, 20-090

Poland

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Warsaw, 02-781

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Wroclaw, 50-019

Poland

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Wroclaw, 53-439

Poland

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San Juan, 00918

Puerto Rico

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Busan, 49201

South Korea

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Busan, 49241

South Korea

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Goyang-si, 10408

South Korea

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Jeonnam, 519-763

South Korea

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Seoul, 03080

South Korea

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Seoul, 03722

South Korea

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Seoul, 05505

South Korea

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Seoul, 06351

South Korea

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Seoul, 06591

South Korea

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Barcelona, 08035

Spain

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Barcelona, 8036

Spain

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El Palmar, 30120

Spain

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Girona, 17007

Spain

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Las Palmas de Gran Canaria, 35020

Spain

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Madrid, 28040

Spain

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Madrid, 28041

Spain

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Oviedo, 33011

Spain

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Pamplona, 31008

Spain

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Santander, 39008

Spain

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Falun, 79182

Sweden

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Uppsala, 75185

Sweden

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Changhua, 50006

Taiwan

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Kaohsiung City, 80756

Taiwan

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Kaohsiung City, 833

Taiwan

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Lukang Township, 505029

Taiwan

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Tainan, 704

Taiwan

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Taipei, 106

Taiwan

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Bangkok, 10330

Thailand

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Bangkok, 10700

Thailand

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Chiang Mai, 50200

Thailand

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Khon Kaen, 40002

Thailand

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Ankara, 6200

Turkey (Türkiye)

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Ankara, 6620

Turkey (Türkiye)

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Istanbul, 34010

Turkey (Türkiye)

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Istanbul, 34854

Turkey (Türkiye)

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Izmir, 35340

Turkey (Türkiye)

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London, EC1M6BQ

United Kingdom

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London, SE5 9RS

United Kingdom

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Newcastle upon Tyne, NE7 7DN

United Kingdom

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Norwich, NR4 7UY

United Kingdom

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Nottingham, NG5 1PB

United Kingdom

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Plymouth, PL6 8DH

United Kingdom

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Southampton, SO16 6YD

United Kingdom