Chronic Lymphocytic Leukemia Clinical Trial
Study of LOXO-305 Versus Investigator’s Choice (IdelaR or BR) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Summary
This is a study for patients with leukemia-cll/" >chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress.
Full Description
This is a Phase 3 global, randomized, open-label study comparing LOXO-305 (Arm A) to investigator's choice of either idelalisib plus rituximab or bendamustine plus rituximab (Arm B) in CLL/SLL patients who have been treated with at least a covalent BTK inhibitor (BTKi). Patients may have discontinued the prior covalent BTKi due to disease progression (PD) or intolerance. Patients who have received venetoclax are eligible for the study. Eligible patients will be randomized in 1:1 to Arm A and Arm B.
Eligibility Criteria
Inclusion Criteria:
Confirmed diagnosis of CLL/SLL requiring therapy as defined by iwCLL 2018 criteria.
Previously treated with a covalent BTK inhibitor.
Eastern Cooperative Oncology Group (ECOG) 0-2.
Absolute neutrophil count ≥ 0.75 × 10^9/L without granulocyte-colony-stimulating factor support, or ≥ 0.50 × 10^9/L in patients with documented bone marrow involvement considered to impair hematopoiesis. Granulocyte-colony-stimulating factor support is permitted in patients with documented bone marrow involvement.
Hemoglobin ≥ 8 g/dL or ≥ 6 g/dL in patients with documented bone marrow involvement considered to impair hematopoiesis. Transfusion support is permitted in patients with bone marrow involvement.
Platelets ≥ 50 × 10^9/L. If an investigator has chosen bendamustine/rituximab as the Arm B treatment, platelets must be ≥ 75 × 10^9/L. Patients may enroll below these thresholds if the Investigator determines the cytopenia is related to bone marrow involvement considered to impair hematopoiesis. Patients with a platelet count < 30 x 10^9/L are excluded.
AST and ALT ≤ 3.0 x upper limit of normal (ULN).
Total bilirubin ≤ 1.5 x ULN.
Estimated creatinine clearance of ≥ 30 mL/min.
Exclusion Criteria:
Known or suspected Richter's transformation at any time preceding enrollment.
Known or suspected history of central nervous system (CNS) involvement by CLL/SLL.
Ongoing drug-induced liver injury.
Active uncontrolled auto-immune cytopenia.
Significant cardiovascular disease.
History of allogeneic or stem cell transplantation (SCT) or chimeric antigen receptor-modified T cells (CAR-T) therapy within the past 60 days.
Active hepatitis B or hepatitis C.
Known active cytomegalovirus (CMV) infection.
Active uncontrolled systemic bacterial, viral, fungal or parasitic infection.
Known Human Immunodeficiency Virus (HIV) infection, regardless of CD4 count.
Clinically significant active malabsorption syndrome or inflammatory bowel disease
Prior exposure to non-covalent (reversible) BTK inhibitor.
Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist.
Current treatment with strong cytochrome P450 (CYP) 3A4 (CYP3A4) inhibitors or inducers.
Vaccination with a live vaccine within 28 days prior to randomization.
Patients with the following hypersensitivity:
Known hypersensitivity, including anaphylaxis, to any component or excipient of LOXO-305. For patients planned to receive idelalisib, known hypersensitivity, including anaphylaxis, to any component or excipient of idelalisib. For patients planned to receive bendamustine, known hypersensitivity, including anaphylaxis, to any component or excipient of bendamustine.
Prior significant hypersensitivity to rituximab.
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There are 222 Locations for this study
Daphne Alabama, 36526, United States More Info
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Mobile Alabama, 36604, United States More Info
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Glendale Arizona, 85304, United States More Info
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Tucson Arizona, 85711, United States More Info
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Fountain Valley California, 92708, United States More Info
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Los Angeles California, 90027, 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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Boca Raton Florida, 33486, United States More Info
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Jacksonville Florida, 32256, United States More Info
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Tamarac Florida, 33321, United States More Info
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Marietta Georgia, 30060, United States More Info
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Chicago Illinois, 60612, United States More Info
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Niles Illinois, 60714, United States More Info
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Indianapolis Indiana, 46250, United States More Info
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Lafayette Indiana, 47904, United States More Info
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Lexington Kentucky, 40563, United States More Info
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Louisville Kentucky, 40207, United States More Info
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Paducah Kentucky, 42003, 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, 48106, United States More Info
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Grosse Pointe Woods Michigan, 48236, United States More Info
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Saint Paul Minnesota, 55102, United States More Info
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Billings Montana, 59102, United States More Info
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Lincoln Nebraska, 68506, United States More Info
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Brick New Jersey, 08724, United States More Info
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New York New York, 10021, United States More Info
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Rochester New York, 14642, United States More Info
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Westbury New York, 11590, 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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Rock Hill South Carolina, 29732, United States More Info
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Amarillo Texas, 79106, United States More Info
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Austin Texas, 78705, United States More Info
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Dallas Texas, 75230, United States More Info
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Dallas Texas, 75231, United States More Info
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Fort Sam Houston Texas, 78234, United States More Info
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Fort Worth Texas, 76104, United States More Info
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Fort Worth Texas, 76104, United States More Info
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McAllen Texas, 78503, United States More Info
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San Antonio Texas, 78240, United States More Info
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Gainesville Virginia, 20155, United States More Info
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Roanoke Virginia, 24014, United States More Info
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Tacoma Washington, 98405, United States More Info
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Madison Wisconsin, 53705, United States More Info
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Garran Australian Capital Territory, 2605, Australia More Info
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Darlinghurst New South Wales, 2010, Australia More Info
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Kogarah New South Wales, 2217, Australia More Info
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Liverpool New South Wales, NSW21, Australia More Info
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Wentworthville New South Wales, 2145, Australia More Info
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Perth Western Australia, 6000, 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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Sint-Niklaas Oost-Vlaanderen, B-910, Belgium More Info
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Ottignies , 1340, Belgium More Info
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Winnipeg Manitoba, R3E 0, Canada More Info
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Halifax Nova Scotia, B3H 1, Canada More Info
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Newmarket Ontario, L3Y 2, Canada More Info
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Toronto Ontario, M5G 1, Canada More Info
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Beijing Beijing, 10003, China More Info
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Beijing Beijing, 10019, China More Info
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Xicheng District Beijing, 10005, China More Info
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Guangzhou Guangdong, 51000, China More Info
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Guangzhou Guangdong, 51051, China More Info
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Haikou Hainan, 57010, China More Info
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Xuzhou Jiangsu, 22100, China More Info
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Nanchang Jiangxi, 33000, China More Info
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Nanchang Jiangxi, 33000, China More Info
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Tianjin Tianjin, , China More Info
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Ürümqi Xinjiang, 83000, China More Info
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Hangzhou Zhejiang, 31002, China More Info
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Linhai Zhejiang, 31700, China More Info
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Shanghai , 20002, 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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Zagreb , , Croatia More Info
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Hradec Kralove , 500 0, Czechia More Info
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Praha 2 , 12808, Czechia More Info
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Grenoble Cedex 09, 38043, France More Info
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Pierre Benite Cedex, 69495, France More Info
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La Roche-sur-Yon La Roche Sur Yon, 85000, France More Info
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Nîmes Nimes, 30900, 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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Bayonne , 64109, France More Info
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Bordeaux , 33076, France More Info
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Brest cedex , 29609, France More Info
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Lille cedex , 59020, France More Info
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Politiers , 86021, France More Info
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Heidelberg Baden-Württemberg, 69120, Germany More Info
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Ulm Baden-Württemberg, 89081, Germany More Info
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Langenbeckstraße 1 Mainz, D- 55, Germany More Info
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Koelner Platz 1 München, 80804, Germany More Info
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Kiel Schleswig-Holstein, 24105, Germany More Info
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Lübeck Schleswig-Holstein, 23562, Germany More Info
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Berlin , 12203, Germany More Info
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Budapest , 1097, Hungary More Info
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Debrecen , 4032, Hungary More Info
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Nyiregyhaza , 4400, Hungary More Info
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Pecs , 7624, Hungary More Info
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Dublin 8 , D08 N, Ireland More Info
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Tel Aviv , 64239, Israel More Info
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Viale Orazio Flacco Bari, 70124, Italy More Info
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Monza (MB) -Settore E Piano 2, 20900, Italy More Info
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Pisa PI, 56126, Italy More Info
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Rionero In Vulture Potenza, 85028, Italy More Info
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Vicenza Veneto, 36100, Italy More Info
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Alessandria , 15100, Italy More Info
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Bergamo , 24127, Italy More Info
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Brescia , 25123, Italy More Info
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Catania , 95123, Italy More Info
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Catanzaro , 88100, Italy More Info
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Firenze , 50134, Italy More Info
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Genova , 16132, Italy More Info
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Milano , 20162, Italy More Info
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Pavia , 27100, Italy More Info
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Perugia , 06132, Italy More Info
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Ravenna , 48020, Italy More Info
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Roma , 00168, Italy More Info
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Terni , 05100, Italy More Info
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Torino , 10126, Italy More Info
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Trieste , 34125, Italy More Info
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Verona , 37134, Italy More Info
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Nagoya Aichi, 464-8, Japan More Info
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Nagoya Aichi, 467-8, Japan More Info
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Ogaki-shi Gifu, 503-8, 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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Isehara Kanagawa, 259-1, Japan More Info
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Nankoku Kochi, 783-8, Japan More Info
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Sendai-shi Miyagi-Ken, 983-8, 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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Namdong-gu Incheon-gwangyeoksi [Incheon], 21565, Korea, Republic of More Info
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Busan Pusan-Kwangyǒkshi, 49241, 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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Seocho-Gu Seoul, 06591, Korea, Republic of More Info
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Busan , 47392, Korea, Republic of More Info
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Iwaszkiewicza 5 Legnica, 59-22, Poland More Info
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Lublin Lubelskie, 20-08, Poland More Info
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Gdansk Pomorskie, 80-21, Poland More Info
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Gdynia Pomorskie, 81-51, Poland More Info
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Brzozów , 36-20, Poland More Info
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Bydgoszcz , 85-16, Poland More Info
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Katowice , 40519, Poland More Info
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Walbrzych , 58-30, Poland More Info
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Warszawa , 02-77, Poland More Info
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Warszawa , 02-78, Poland More Info
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Wrocław , 50-36, 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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Saint Petersburg , 19102, Russian Federation More Info
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Saint Petersburg , 19702, Russian Federation More Info
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Sochi , 35405, Russian Federation More Info
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Singapore Central Singapore, 25849, Singapore More Info
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Hospitalet De Llobregat Barcelona, 08908, Spain More Info
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Toledo Castilla La Mancha, 45004, Spain More Info
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Santiago de Compostela La Coruna, 15706, Spain More Info
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Madrid Madrid, Comunidad De, 28034, Spain More Info
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Pozuelo De Alarcón Madrid, 28223, Spain More Info
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Madrid Planta Baja, 28007, Spain More Info
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Albacete , 02006, Spain More Info
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Barcelona , 08035, Spain More Info
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Barcelona , 08036, Spain More Info
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Caceres , 10003, Spain More Info
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Madrid , 28031, Spain More Info
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Madrid , 28046, Spain More Info
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Santander , 39008, Spain More Info
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Sevilla , 41013, Spain More Info
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Vitoria , 01005, Spain More Info
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Bellinzona Svizzera, 6500, Switzerland More Info
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Taichung City Taichung, 40447, Taiwan More Info
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Taipei City Taipei, 114, Taiwan More Info
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Taipei City , 11220, Taiwan More Info
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Taoyuan, (r.o.c.) , 33342, Taiwan More Info
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Mamak Ankara, , Turkey More Info
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Faith Istanbul, , Turkey More Info
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Kayseri Melikgazi, 38039, Turkey More Info
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Ankara Yenimahalle, 06560, Turkey More Info
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Izmir , 35330, Turkey More Info
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Aberdeen Aberdeen City, AB25 , United Kingdom More Info
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Truro Cornwall, TR1 3, United Kingdom More Info
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Plymouth Devon, PL6 8, United Kingdom More Info
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Cottingham East Yorkshire, HU16 , United Kingdom More Info
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London Greater London, WC1E , United Kingdom More Info
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Norwich Norfolk, NR4 7, United Kingdom More Info
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Edinburgh Scotland, EH4 2, United Kingdom More Info
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Sutton Surrey, SM2 5, United Kingdom More Info
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Livingston West Lothian, EH54 , United Kingdom More Info
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Leeds , LS9 7, United Kingdom More Info
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Milton Keynes , MK6 5, United Kingdom More Info
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Newmarket , CB8 7, United Kingdom More Info
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