New targeted combo aims to slow mantle cell lymphoma

NCT ID NCT02972840

Disease control Sponsor: Acerta Pharma BV Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests whether adding the targeted drug acalabrutinib to standard chemotherapy (bendamustine and rituximab) helps people with untreated mantle cell lymphoma live longer without their cancer getting worse. About 635 patients aged 65 and older are taking part. The study compares the combination against chemotherapy alone to see if the new approach is more effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: acalabrutinib (a targeted cancer drug) combined with bendamustine and rituximab (chemotherapy and immunotherapy)
What this could lead to: If successful, this combination could become a new standard first-line treatment for mantle cell lymphoma, potentially delaying disease progression.
What could go wrong: This is an advanced phase 3 trial, but adding a targeted drug to chemotherapy may increase side effects. The benefit over standard therapy is not yet proven, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

635 people

The number who actually took part.

Started

Apr 2017

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Men and women, ≥ 65 years of age. * Pathologically confirmed MCL, with documentation of a chromosome translocation t(11;14)(q13;q32) and/or overexpression of cyclin D1 in association with other relevant markers (eg, CD5, CD19, CD20, PAX5) . * MCL requiring treatment and for which no prior systemic anticancer therapies have been received. * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. * Agreement to use highly effective forms of contraception during the study and 6 months after the last dose of bendamustine, or 12 months after the last dose of rituximab, whichever is longest . Exclusion Criteria: * Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of first dose of study drug, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or corrected QT interval (QTc) \> 480 msec (calculated using Friderica's formula: QT/RR0.33) at screening. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study. * Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass. * Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment), or intravenous anti infective treatment within 2 weeks before first dose of study drug. * Concurrent participation in another therapeutic clinical trial.

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Conditions

The condition(s) this trial relates to.

mantle cell lymphoma non-Hodgkin lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lymphoma, mantle cell

Contacts and locations

Locations

Research Site

Tucson, Arizona, 85719, United States
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Downey, California, 90241, United States
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Santa Monica, California, 90404, United States
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New Haven, Connecticut, 06510, United States
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Washington D.C., District of Columbia, 20007, United States
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Tallahassee, Florida, 32308-5304, United States
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West Palm Beach, Florida, 33401, United States
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Marietta, Georgia, 30060, United States
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Westwood, Kansas, 66205, United States
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Louisville, Kentucky, 40207, United States
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Ann Arbor, Michigan, 48109, United States
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Rochester, Minnesota, 55905-0001, United States
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Kansas City, Missouri, 64132, United States
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St Louis, Missouri, 63110, United States
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Hackensack, New Jersey, 07601, United States
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Morristown, New Jersey, 07960, United States
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Hawthorne, New York, 10532, United States
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Lake Success, New York, 11042, United States
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Portland, Oregon, 97239, United States
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Charleston, South Carolina, 29425, United States
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Greenville, South Carolina, 29615, United States
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Chattanooga, Tennessee, 37404, United States
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Nashville, Tennessee, 37203, United States
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Houston, Texas, 77030, United States
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San Antonio, Texas, 78217, United States
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Tyler, Texas, 75702, United States
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Charlottesville, Virginia, 22908, United States
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Fort Belvoir, Virginia, 22060, United States
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Seattle, Washington, 98108, United States
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Seattle, Washington, 98109, United States
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Seattle, Washington, 98122, United States
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Morgantown, West Virginia, 26506, United States
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Buenos Aires, C1114AAP, Argentina
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Buenos Aires, C1426ANZ, Argentina
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Buenos Aires, C1430EGF, Argentina
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Buenos Aires, C1431FWO, Argentina
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Caba, C1118AAT, Argentina
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Córdoba, 5000, Argentina
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Bedford Park, 5042, Australia
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Concord, 2139, Australia
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Frankston, 3199, Australia
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Gosford, 2250, Australia
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Heidelberg, 3084, Australia
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Herston, QLD, 4029, Australia
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Kogarah, NSW 2217, Australia
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Murdoch, 6150, Australia
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Nedlands, 6009, Australia
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Newcastle, 2298, Australia
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Southport, 4215, Australia
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Sydney, NSW 2145, Australia
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Woolloongabba, 4102, Australia
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Antwerp, 2060, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Roeselare, 8900, Belgium
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Sint-Niklaas, 9100, Belgium
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Bela Vista, 01321-001, Brazil
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Curitiba, 81520-060, Brazil
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Porto Alegre, 90035-903, Brazil
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Porto Alegre, RS 90610-000, Brazil
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Rio de Janeiro, 20231-050, Brazil
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Salvador, 41253-190, Brazil
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São Paulo, 01232-010, Brazil
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São Paulo, 05652-9000, Brazil
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São Paulo, 1236030, Brazil
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São Paulo, 5403, Brazil
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So Paulo, 08270-070, Brazil
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Vancouver, British Columbia, V5Z 4E6, Canada
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Oshawa, Ontario, L1G 2B9,, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Edmonton, T6G 1Z2, Canada
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Greenfield Park, J4V 2H1, Canada
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Halifax, NS B3H 2Y9, Canada
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Beijing, 100036, China
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Changchun, 130021, China
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Changsha, 410008, China
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Changsha, 410013, China
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Chongqing, 400037, China
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Dalian, 116023, China
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Gongshu District, 310022, China
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Haidian District, 100191, China
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Harbin, 150081, 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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Qingdao, 266100, China
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Shanghai, China
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Shenyang, China
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Suzhou, 215006, China
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Tianjian, 300020, China
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Tianjin, China
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Wenzhou, 325000, China
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Wuhan, 430030, China
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Wuhan, 430079, China
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Wuhou District, 610041, China
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Xicheng District, 100050, China
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Xuhui District, 200032, China
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Xuzhou, 221000, 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, CZ, Czechia
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Ostrava Poruba, 708 52, Czechia
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Pilsen, 30460, CZ, Czechia
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Prague, 100 34, CZ, Czechia
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Argenteuil, 95100, France
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Bobigny, 93000, France
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Bordeaux, 33076, FR, France
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Le Mans, 72000, FR, France
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Limoges, 87042, France
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Pessac, 33604, France
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Périgueux, 24019, France
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Rennes, 35000, France
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Vienne, 86000, FR, France
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Heidelberg, 69120, DE, Germany
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München, 81377, DE, Germany
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Münster, 48149, Germany
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Nordrhein-Westfalen, 52064, DE, Germany
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Ravensburg, 88212, Germany
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Rheinland-Pfalz, 55131, DE, Germany
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Ulm, 89081, Germany
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Athens, 11525, Greece
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Athens, 11527, GR, Greece
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Athens, 11528, GR, Greece
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Ioannina, 45500, GR, Greece
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Pátrai, 26504, Greece
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Thessaloniki, 54007, GR, Greece
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Thessaloniki, 57010, GR, Greece
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Hong Kong, 999077, Hong Kong
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Pok Fu Lam, Hong Kong
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Budapest, 1085, 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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Pécs, 7624, Hungary
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Szeged, 6725, Hungary
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Haifa, 31096, Israel
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Jerusalem, 9103102, Israel
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Petah Tikva, 494142, Israel
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Tel Aviv, 64239, Israel
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Bologna, 40138, Italy
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Milan, 20132, Italy
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Milan, 20162, Italy
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Palermo, 90146, Italy
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Parma, Italy
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Pavia, 27100, Italy
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Reggio Emilia, 42123, Italy
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Rozzano, 20089, Italy
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Turin, 10126, Italy
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Fukuoka, 811-1395, Japan
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Fukuoka, 812-8582, Japan
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Kobe, 650-0047, Japan
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Kyoto, 602-8026, Japan
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Matsuyama, 791-0280, Japan
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Nagoya, 460-0001, Japan
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Nagoya, 464-8681, Japan
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Osaka, 565-0871, Japan
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Sapporo, 003-0006, Japan
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Sendai, 980-8574, Japan
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Shimane, 693-8501, Japan
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Tokyo, 104-0045, Japan
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Tokyo, 135-8550, Japan
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Yokohama, 241-8515, Japan
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Mexico City, 2990, Mexico
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México, 14080, Mexico
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Monterrey, Mexico
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Querétaro, 76090, Mexico
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Dunedin, 9016, New Zealand
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Grafton, 1023, New Zealand
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Otahuhu, 1640, New Zealand
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Arequipa, 5154, Peru
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Bellavista, Peru
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Lima, 1, Peru
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Lima, 34, Peru
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Chorzów, 41-500, Poland
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Krakow, 30-510, Poland
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Lodz, 93-510, Poland
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Lublin, 20-090, Poland
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Olsztyn, 10-228, Poland
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Warsaw, 02-106, Poland
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Warsaw, 02-776, Poland
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Warsaw, 04-141, Poland
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Woj. Podkarpackie, 36-200, Poland
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Wroclaw, 50-367, Poland
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Brasov, 50012, Romania
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Bucharest, 070131, Romania
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Cluj-Napoca, 400124, Romania
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Iași, 700483, Romania
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Pyatigorsk, 357532, Russia
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Saint Petersburg, 197022, Russia
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Saint Petersburg, 197341, Russia
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Saint Petersburg, Russia
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Syktyvkar, 167029, Russia
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Tula, 300053, Russia
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Busan, 49201, South Korea
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Gyeonggi-do, 13620, South Korea
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Seoul, 3080, South Korea
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Seoul, 3722, South Korea
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Seoul, 5505, South Korea
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Seoul, 6351, South Korea
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Seoul, 6591, South Korea
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Seoul, 7985, South Korea
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Badalona, 8916, Spain
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Barcelona, 08041, Spain
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Barcelona, 8003, Spain
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Barcelona, 8035, Spain
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Barcelona, 8907, Spain
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Madrid, 28007, Spain
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Madrid, 28040, Spain
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Madrid, 28046, Spain
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Majadahonda, 28222, Spain
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Pamplona, 31008, Spain
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Seville, Spain
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Valencia, 46026, Spain
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Kaohsiung City, 833, Taiwan
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Taichung, 40447, Taiwan
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Taipei, 100, Taiwan
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Taoyuan, 333, Taiwan
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Cherkasy, 18009, Ukraine
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Chernihiv, 14029, Ukraine
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Dnipropetrovsk, 49102, Ukraine
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Kiev, 3022, Ukraine
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Lviv, 79044, Ukraine
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Zhytomyr, 10002, Ukraine
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Hanoi, 123, Vietnam
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Hanoi, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Ho Chi Minh City, WARD 7, Vietnam

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