A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients
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
Interventions
Surovatamig
R-CHOP
R-CVP
BR
Conditions
Locations
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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
United States
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San Diego, California 92121
United States
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Santa Monica, California 90404
United States
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Aurora, Colorado 80045
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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
United States
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Atlanta, Georgia 30322
United States
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Macon, Georgia 31201
United States
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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
United States
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Des Moines, Iowa 50309
United States
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Iowa City, Iowa 52242
United States
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Lexington, Kentucky 40536
United States
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Louisville, Kentucky 40207
United States
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Baton Rouge, Louisiana 70808
United States
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Baltimore, Maryland 21201
United States
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Bethesda, Maryland 20817
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Columbia, Maryland 21044
United States
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Boston, Massachusetts 02114
United States
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Boston, Massachusetts 02215
United States
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Ann Arbor, Michigan 48109
United States
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Detroit, Michigan 48201
United States
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Ypsilanti, Michigan 48197
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Saint Paul, Minnesota 55102
United States
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Springfield, Missouri 65807
United States
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Hackensack, New Jersey 07601
United States
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New Brunswick, New Jersey 08901
United States
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Albany, New York 12206
United States
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New Hyde Park, New York 11042
United States
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New York, New York 10016
United States
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New York, New York 10032
United States
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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
United States
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Columbus, Ohio 43210
United States
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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
United States
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Salt Lake City, Utah 84112
United States
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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
Poland
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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