Non Hodgkin Lymphoma Clinical Trial
Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)
Summary
This is a study for participants with a type of blood cancer called mantle cell lymphoma (MCL). The main purpose is to compare pirtobrutinib (LOXO-305) to other drugs that work in a similar way that have already been approved by the United States Food and Drug Administration (US FDA). Participation could last up to two years, and possibly longer, if the disease does not progress.
Full Description
This is a Phase 3 global, randomized, open-label study comparing pirtobrutinib (Arm A) to investigator's choice of ibrutinib, acalabrutinib or zanubrutinib (Arm B) in MCL patients who have received 1 or more lines of therapy and are BTK inhibitor naïve.
Eligibility Criteria
Inclusion Criteria:
Confirmed MCL diagnosis
Previously treated with at least one prior line of systemic therapy for MCL
Measurable disease per Lugano criteria
Eastern Cooperative Oncology Group (ECOG) 0-2
Absolute neutrophil count ≥ 0.75 × 109/L without granulocyte-colony stimulating factor support within 7 days of screening
Hemoglobin ≥ 8 g/dL not requiring transfusion support or growth factors within 7 days of screening
Platelets ≥ 50 × 109/L not requiring transfusion support or growth factors within 7 days of screening.
AST and ALT ≤ 3.0 x upper limit of normal (ULN)
Total bilirubin ≤ 1.5 x ULN.
Creatinine clearance of ≥ 30 mL/min according to Cockcroft/Gault Formula
Exclusion Criteria:
Prior treatment with an approved or investigational BTK inhibitor
History of bleeding diathesis
History of stroke or intracranial hemorrhage within 6 months of randomization
History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor modified T-cell (CAR-T) therapy within 60 days of randomization
Clinically significant cardiovascular disease
Prolonged QT interval corrected using Fridericia's formula (QTcF) > 470 ms on 2/3 consecutive ECGs, and mean QTcF>470 ms on all 3 ECGs
Known HIV infection or active HBV, HCV, or CMV infections. (Certain participants with controlled HBV infections may still be eligible)
Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption
Ongoing chronic treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers which cannot be stopped within 3-5 half lives of the CYP3A inhibitor therapy prior to start of study drug treatment.
Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist.
Vaccination with live vaccine within 28 days prior to randomization
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There are 179 Locations for this study
Phoenix Arizona, 85016, United States More Info
Principal Investigator
Tucson Arizona, 85711, United States More Info
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Fullerton California, 92835, United States More Info
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Long Beach California, 90805, United States More Info
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Aurora Colorado, 80012, United States More Info
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Newark Delaware, 19713, United States More Info
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Fort Myers Florida, 33901, United States More Info
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Jacksonville Florida, 32224, United States More Info
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Saint Petersburg Florida, 33705, United States More Info
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Tallahassee Florida, 32308, United States More Info
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Tamarac Florida, 33321, United States More Info
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West Palm Beach Florida, 33401, United States More Info
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Lexington Kentucky, 40504, United States More Info
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Paducah Kentucky, 42003, United States More Info
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Baton Rouge Louisiana, 70809, United States More Info
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New Orleans Louisiana, 70112, United States More Info
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Baltimore Maryland, 21201, United States More Info
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Ann Arbor Michigan, 48109, United States More Info
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Detroit Michigan, 48201, United States More Info
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Kansas City Missouri, 64132, United States More Info
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Saint Louis Missouri, 63110, United States More Info
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Omaha Nebraska, 68105, United States More Info
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Las Vegas Nevada, 89169, United States More Info
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Morristown New Jersey, 07960, United States More Info
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New York New York, 10032, United States More Info
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New York New York, 10065, United States More Info
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New York New York, 10532, United States More Info
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Asheville North Carolina, 28806, United States More Info
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Charlotte North Carolina, 28204, United States More Info
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Winston-Salem North Carolina, 27157, United States More Info
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Cincinnati Ohio, 45236, United States More Info
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Eugene Oregon, 97401, United States More Info
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Salem Oregon, 97301, United States More Info
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Pittsburgh Pennsylvania, 15213, United States More Info
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Nashville Tennessee, 37203, United States More Info
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Austin Texas, 78705, United States More Info
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Bedford Texas, 76022, United States More Info
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Houston Texas, 77030, United States More Info
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McAllen Texas, 78503, United States More Info
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McKinney Texas, 75071, United States More Info
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Sherman Texas, 75090, United States More Info
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Tyler Texas, 75702, United States More Info
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Salt Lake City Utah, 84112, United States More Info
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Gainesville Virginia, 20155, United States More Info
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Seattle Washington, 98109, United States More Info
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Madison Wisconsin, 53705, United States More Info
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Milwaukee Wisconsin, 53226, United States More Info
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Kogarah New South Wales, 2217, Australia More Info
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Adelaide South Australia, 5042, Australia More Info
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Hobart Tasmania, 7000, Australia More Info
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Geelong Victoria, 3220, Australia More Info
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Nedlands Western Australia, WA600, Australia More Info
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Perth Western Australia, 6000, Australia More Info
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Auchenflower , 4066, Australia More Info
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Linz Oberösterreich, 4020, Austria More Info
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Salzburg Osterreich, 5020, Austria More Info
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Leuven , 3000, Belgium More Info
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Edmonton Alberta, T6G 1, Canada More Info
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Vancouver British Columbia, V5Z 1, Canada More Info
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Hefei Anhui, 23300, China More Info
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Beijing Beijing, 10003, China More Info
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Beijing Beijing, 10004, China More Info
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Beijing Beijing, 10014, China More Info
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Beijing Beijing, 10019, China More Info
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Haidian District Beijing, 10014, China More Info
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Guangzhou Guangdong, 51000, China More Info
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Guangzhou Guangdong, 51006, China More Info
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Guangzhou Guangdong, 51051, China More Info
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Suzhou Jiangsu, 21506, China More Info
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Nanchang Jiangxi, 33000, China More Info
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Shenyang Liaoning, 11000, China More Info
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Chengdu Sichuan, 61004, China More Info
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Tianjin Tianjin, 30006, China More Info
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Urumqi Xinjiang, 83000, China More Info
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Hangzhou Zhejiang, 31002, China More Info
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Shanghai , 20003, China More Info
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Tianjin , 30002, China More Info
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Hradec Kralove , 500 0, Czechia More Info
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Aarhus N Jutland, DK-82, Denmark More Info
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Odense , DK-50, Denmark More Info
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Bordeaux Aquitaine, 33076, France More Info
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Rouen Seine-Maritime, 76038, France More Info
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Tours Tours Cedex 9, 37044, France More Info
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Lille cedex , 59020, France More Info
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Nantes Cedex 1 , 44093, France More Info
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Pessac Cedex , 33600, France More Info
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Pierre Benite Cedex , 69495, France More Info
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Politiers , 86021, France More Info
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Vandœuvre-lès-Nancy , 54500, France More Info
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Saint-Cloud Île-de-France, 92210, France More Info
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Ulm Baden-Württemberg, 89081, Germany More Info
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München Bayern, 81377, Germany More Info
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Mainz , 55131, Germany More Info
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Dublin Dublin 8, D08 N, Ireland More Info
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Tel Aviv , 64239, Israel More Info
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Alessandria AL, 15100, Italy More Info
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Viale Orazio Flacco Bari, 70124, Italy More Info
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Meldola Emilia-Romagna, 47014, Italy More Info
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Milano Lombardia, 20132, Italy More Info
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Rionero in Vulture Potenza, 85028, Italy More Info
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Genova , 16132, Italy More Info
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Messina , 98158, Italy More Info
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Ravenna , 48020, Italy More Info
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Reggio Emilia , 42123, Italy More Info
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Varese , 21100, Italy More Info
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Nagoya Aichi, 467-8, Japan More Info
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Sapporo Hokkaido, 060-8, Japan More Info
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Kobe Hyogo, 650-0, Japan More Info
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Nankoku Kochi, 783-8, Japan More Info
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Sendai-shi Miyagi, 980-8, Japan More Info
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Osaka Sayama-shi Osaka, 589 8, Japan More Info
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Kawagoe Saitama, 350-8, Japan More Info
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Koto Tokyo, 135-8, Japan More Info
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Shinagawa-KU Tokyo, 141-8, Japan More Info
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Kyoto-shi , 602 8, Japan More Info
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Namdong-gu Incheon-gwangyeoksi [Incheon], 21565, Korea, Republic of More Info
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Busan Seogu, 49267, Korea, Republic of More Info
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Seoul Seoul, Korea, 03080, Korea, Republic of More Info
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Seoul Seoul-teukbyeolsi [Seoul], 03722, Korea, Republic of More Info
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Seoul Seoul-teukbyeolsi [Seoul], 05505, Korea, Republic of More Info
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Seoul Seoul-teukbyeolsi [Seoul], 06351, Korea, Republic of More Info
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Seocho-Gu Seoul, 06591, Korea, Republic of More Info
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Busan , 47392, Korea, Republic of More Info
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Den Haag , 2545 , Netherlands More Info
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Rotterdam , 3015 , Netherlands More Info
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Papatoetoe Auckland, 2025, New Zealand More Info
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Lublin Lubelskie, 20-08, Poland More Info
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Gdańsk Pomorskie, 80-21, Poland More Info
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Skórzewo , 60-18, Poland More Info
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Łódź , 93510, Poland More Info
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Omsk Omskaya Oblast', 64401, Russian Federation More Info
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Moscow , 12510, Russian Federation More Info
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Saint Petersburg , 19102, Russian Federation More Info
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Saint-Petersburg , 19702, Russian Federation More Info
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Hospitalet De Llobregat Barcelona, 08908, Spain More Info
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Barcelona , 08035, Spain More Info
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Madrid , 28007, Spain More Info
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Madrid , 28031, Spain More Info
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Madrid , 28040, Spain More Info
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Madrid , 28041, Spain More Info
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Pamplona , 31008, Spain More Info
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Luzern 16 Luzern, 6000, Switzerland More Info
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Bellinzona , CH-65, Switzerland More Info
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Taipei City Taipei, 114, Taiwan More Info
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Chiayi County , 61363, Taiwan More Info
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Kaohsiung , 80756, Taiwan More Info
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Taichung , 40447, Taiwan More Info
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Tainan , 704, Taiwan More Info
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Taipei , 10002, Taiwan More Info
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Taipei , 11217, Taiwan More Info
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Taoyuan City , 333, Taiwan More Info
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Aberdeen Aberdeen City, AB25 , United Kingdom More Info
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Headington Oxford, OX3 7, United Kingdom More Info
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Sutton Surrey, SM2 5, United Kingdom More Info
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Newmarket , CB8 7, United Kingdom More Info
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Nottingham , NG5 1, United Kingdom More Info
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Windsor , SL4 3, United Kingdom More Info
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Wolverhampton , WV10 , United Kingdom More Info
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