Hope for aggressive lymphoma: targeted drug added to chemo in major trial

NCT ID NCT04529772

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

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether adding the targeted drug acalabrutinib to standard chemotherapy (R-CHOP) helps people with a specific, aggressive type of lymphoma (non-GCB DLBCL) live longer without their cancer getting worse. About 611 adults aged 18 to 75 who have not been treated before are taking part. The study compares the combination against chemotherapy plus a placebo to see if it improves progression-free survival.

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 standard chemotherapy (R-CHOP)
What this could lead to: If successful, this could offer a more effective first-line treatment for a hard-to-treat subtype of lymphoma, potentially delaying or preventing relapse.
What could go wrong: This is a Phase 3 trial, but results are not yet available. Adding acalabrutinib may increase side effects, and it may not improve outcomes over standard therapy alone.

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

611 people

The number who actually took part.

Started

Oct 2020

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

18 to 75 years

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, age ≥18 and ≤75 years * Pathologically confirmed DLBCL, sufficient diagnostic material should be available to forward to a central laboratory for gene expression profiling and pathology review. * No prior treatment for DLBCL * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. * International Prognostic Index (IPI) score of 1 to 5 * Disease Stage II to IV by the Ann Arbor Classification * Adequate organ and marrow function * Agreement to use highly effective forms of contraception during the study and 12 months after the last dose of rituximab Exclusion Criteria: * Evidence of severe or uncontrolled systemic diseases * Known history of a bleeding diathesis (i.e., haemophilia, von Willebrand disease) * History of stroke or intracranial haemorrhage in preceding 6 months. * Known CNS lymphoma or leptomeningeal disease * Known primary mediastinal lymphoma * Known High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements * Prior history of indolent lymphoma or CLL * History of or ongoing confirmed PML * 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 * 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 * Prior anthracycline use ≥150 mg/m2

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Conditions

The condition(s) this trial relates to.

B-cell neoplasm diffuse large B-cell lymphoma diffuse large B-cell lymphoma activated B-cell type lymphatic system disorder lymphoma lymphoproliferative syndrome neoplasm non-Hodgkin lymphoma

As listed by the trial registrant

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

Diffuse large B-cell lymphoma

Contacts and locations

Locations

Research Site

Tucson, Arizona, 85711, United States
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Little Rock, Arkansas, 72205, United States
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Irvine, California, 92618, United States
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Aurora, Colorado, 80012, United States
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Norwich, Connecticut, 06360, United States
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Fort Myers, Florida, 33901, United States
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Orlando, Florida, 32804, United States
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St. Petersburg, Florida, 33705-1449, 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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Fort Wayne, Indiana, 46845, United States
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Des Moines, Iowa, 50309, United States
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Wichita, Kansas, 67214, United States
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Louisville, Kentucky, 40207, United States
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Baltimore, Maryland, 21201, United States
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Grand Rapids, Michigan, 49503, United States
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Minneapolis, Minnesota, 55407, United States
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St Louis, Missouri, 63129, United States
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Albany, New York, 12208, United States
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New York, New York, 10028, United States
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New York, New York, 10065, United States
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Stony Brook, New York, 11795, United States
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Charlotte, North Carolina, 28204, United States
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Winston-Salem, North Carolina, 27103, United States
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Eugene, Oregon, 97401, United States
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Portland, Oregon, 97239, United States
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Philadelphia, Pennsylvania, 19111, United States
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Pittsburgh, Pennsylvania, 15212, United States
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Nashville, Tennessee, 37203, United States
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Fort Sam Houston, Texas, 78234, United States
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Lubbock, Texas, 79410, United States
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Salem, Virginia, 24153, United States
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Camperdown, 2050, Australia
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Darlinghurst, 2010, Australia
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Heidelberg, 3084, Australia
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Hobart, 7000, Australia
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Kogarah, 2217, Australia
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Nedlands, 6009, Australia
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Westmead, 2145, Australia
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Linz, 4021, Austria
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Wels, 4600, Austria
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Antwerp, 2060, Belgium
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Bruges, 8000, Belgium
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Goiânia, 74605-020, Brazil
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Passo Fundo, 99010-260, Brazil
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Porto Alegre, 90110-270, Brazil
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Porto Alegre, 90619-900, Brazil
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Ribeirão Preto, 14051-140, Brazil
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Rio de Janeiro, 22793-080, Brazil
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São Paulo, 01236-030, Brazil
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São Paulo, 01509-900, Brazil
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São Paulo, 04029-000, Brazil
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São Paulo, 08270-070, Brazil
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Vancouver, British Columbia, V5Z 4E6, Canada
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Toronto, CA, M5G 2M9, Canada
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Winnipeg, Manitoba, R3E 0V9, Canada
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London, Ontario, N6A 5W9, Canada
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Lévis, Quebec, G6V 0B8, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H2X 3E4, Canada
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Québec, Quebec, G1J 1Z4, Canada
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Ottawa, K1H 8L6, Canada
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Toronto, M4N 3M5, Canada
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Beijing, 100044, China
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Beijing, 100191, China
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Changchun, 130021, China
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Chengdu, 610041, China
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Guangzhou, 510060, China
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Guangzhou, 510080, China
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Guangzhou, 510120, China
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Hangzhou, 310003, China
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Hangzhou, 310009, China
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Harbin, 150081, China
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Jinan, 250117, China
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Luoyang, 471003, China
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Nanchang, 330006, China
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Nanning, 530021, China
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Shanghai, 200032, China
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Shanghai, China
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Shenyang, 110004, China
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Shenyang, 110042, China
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Shijiazhuang, 050020, China
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Suzhou, 215006, China
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Tianjin, 300020, China
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Tianjin, 300060, China
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Wuhan, 430022, China
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Wuhan, 430030, China
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Xiamen, 361003, 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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Ostrava - Poruba, 708 52, Czechia
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Pilsen, 304 60, Czechia
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Prague, 100 34, Czechia
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Prague, 128 08, Czechia
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Brest, 29609, France
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Caen, 14033, France
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Marseille, 13385, France
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Montpellier, 34295, France
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Nantes, 44093, France
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Pessac, 33604, France
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Pierre-Bénite, 69495, France
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Rennes, 35033, France
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Toulouse, 31100, France
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Bamberg, 96049, Germany
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Berlin, 10967, Germany
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Dresden, 01307, Germany
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Homburg, 66421, Germany
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Neumünster, 24534, Germany
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Bangalore, 560064, India
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Delhi, 110029, India
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Kochi, 682041, India
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Mumbai, 400 012, India
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Nashik, 422004, India
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Nashik, 422009, India
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Pune, 411001, India
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Afula, 18101, Israel
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Ashdod, 7747629, Israel
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Beersheba, 8410101, Israel
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Haifa, 31048, Israel
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Haifa, 31096, Israel
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Haifa, 34362, Israel
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Holon, 58100, Israel
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Jerusalem, 91031, Israel
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Jerusalem, 91120, Israel
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Nahariya, 22100, Israel
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Petah Tikva, 4941492, Israel
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Ramat Gan, 52621, Israel
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Tel Aviv, 6423906, Israel
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Ẕerifin, 70300, Israel
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Bari, 70124, Italy
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Bergamo, 24127, Italy
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Bologna, 40138, Italy
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Florence, 50134, Italy
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Genova, 16132, Italy
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Meldola, 47014, Italy
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Milan, 20141, Italy
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Milan, 20162, Italy
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Novara, 28100, Italy
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Palermo, 90146, Italy
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Pavia, 27100, Italy
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Pisa, 56126, Italy
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Ravenna, 48121, Italy
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Reggio Emilia, 42123, Italy
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Roma, 00144, Italy
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Roma, 00152, Italy
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Siena, 53100, Italy
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Torino, 10126, Italy
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Tricase, 73039, Italy
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Venezia, 30174, Italy
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Chiba, 260-8717, Japan
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Chūōku, 104-0045, Japan
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Fukuoka, 812-8582, Japan
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Itabashi-ku, 173-8610, Japan
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Kahoku-gun, 920-0293, Japan
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Kashiwa, 277-8577, Japan
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Kobe, 650-0047, Japan
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Kōtoku, 135-8550, Japan
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Kumamoto, 860-0008, Japan
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Kumamoto, 860-8556, Japan
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Kyoto, 602-8026, Japan
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Matsuyama, 791-0280, Japan
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Nagasaki, 852-8501, Japan
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Nagoya, 460-0001, Japan
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Nagoya, 464-8681, Japan
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Nagoya, 466-8560, Japan
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Niigata, 951-8520, Japan
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Okayama, 700-8558, Japan
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Osaka, 545-8586, Japan
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Sapporo, 003-0006, Japan
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Sendai, 980-8574, Japan
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Shimotsuke-shi, 329-0498, Japan
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Tsu, 514-8507, Japan
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Chihuahua City, 31000, Mexico
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Monterrey, 64460, Mexico
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Gdansk, 80-952, Poland
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Krakow, 30-510, Poland
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Lodz, 93-510, Poland
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Lublin, 20-081, Poland
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Warsaw, 02-776, Poland
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Wroclaw, 50-367, Poland
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Braga, 4710, Portugal
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Lisbon, 1400-038, Portugal
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Lisbon, 1649-035, Portugal
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Lisbon, 1998-018, Portugal
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Matosinhos Municipality, 4454-509, Portugal
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Porto, 4099-001, Portugal
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Porto, 4200-319, Portugal
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Vila Nova de Gaia, 4434-502, Portugal
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Chelyabinsk, 454087, Russia
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Moscow, 125284, Russia
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Saint Petersburg, 194291, Russia
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Saint Petersburg, 197022, Russia
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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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Jeonju, 54907, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 06591, South Korea
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Seoul, 5505, South Korea
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Seoul, 6351, South Korea
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Suwon, 16499, South Korea
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Alcalá de Henares, 28805, Spain
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Badalona, 08003, Spain
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Barcelona, 08035, Spain
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Gijón, 33394, Spain
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L'Hospitalet de Llobregat, 08908, Spain
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Madrid, 28007, Spain
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Madrid, 28033, Spain
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Madrid, 28034, Spain
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Madrid, 28040, Spain
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Madrid, 28046, Spain
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Palma, 07198, Spain
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Pamplona, 31008, Spain
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Pozuelo de Alarcón, 28223, Spain
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Salamanca, 37007, Spain
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Seville, 41013, Spain
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Valencia, 46026, Spain
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Kaohsiung City, 833, Taiwan
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Tainan, 70403, Taiwan
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Tainan, 736, Taiwan
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Taipei, 100, Taiwan
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Taipei, 235, Taiwan
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Taipei, Taiwan
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Taoyuan City, Taiwan
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Ankara, 06700, Turkey (Türkiye)
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Ankara, 6200, Turkey (Türkiye)
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Ankara, 6500, Turkey (Türkiye)
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Balçova, 35340, Turkey (Türkiye)
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Edirne, 22030, Turkey (Türkiye)
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Izmir, 35040, Turkey (Türkiye)
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Kayseri, 38030, Turkey (Türkiye)
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Mersin, 33079, Turkey (Türkiye)
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Samsun, 55139, Turkey (Türkiye)
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Trabzon, 61080, Turkey (Türkiye)
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Cherkasy, 18009, Ukraine
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Khmelnytskyi, 29000, Ukraine
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Kyiv, 03022, Ukraine
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Kyiv, 04112, Ukraine
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Lviv, 79044, Ukraine
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Mykolayiv, 54058, Ukraine
Research Site

Zaporizhzhia, 69600, Ukraine

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