A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312)
NCT ID: NCT04529772
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
611 participants
INTERVENTIONAL
2020-10-08
2027-02-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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acalabrutinib + R-CHOP
Acalabrutinib plus Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP)
acalabrutinib
Investigational Product
Prednisone
Investigational Product
Rituximab
Investigational Product
Cyclophosphamide
Investigational Product
Vincristine
Investigational Product
Doxorubicin
Investigational Product
placebo + R-CHOP
Placebo plus Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP)
placebo
Placebo comparator
Prednisone
Investigational Product
Rituximab
Investigational Product
Cyclophosphamide
Investigational Product
Vincristine
Investigational Product
Doxorubicin
Investigational Product
Interventions
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acalabrutinib
Investigational Product
placebo
Placebo comparator
Prednisone
Investigational Product
Rituximab
Investigational Product
Cyclophosphamide
Investigational Product
Vincristine
Investigational Product
Doxorubicin
Investigational Product
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Acerta Pharma BV
INDUSTRY
Responsible Party
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Locations
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Irvine, California, United States
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Aurora, Colorado, United States
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Norwich, Connecticut, United States
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Fort Myers, Florida, United States
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Orlando, Florida, United States
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St. Petersburg, Florida, United States
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Tallahassee, Florida, United States
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West Palm Beach, Florida, United States
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Fort Wayne, Indiana, United States
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Des Moines, Iowa, United States
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Wichita, Kansas, United States
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Louisville, Kentucky, United States
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Baltimore, Maryland, United States
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Grand Rapids, Michigan, United States
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Minneapolis, Minnesota, United States
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St Louis, Missouri, United States
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Albany, New York, United States
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New York, New York, United States
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New York, New York, United States
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Stony Brook, New York, United States
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Charlotte, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Eugene, Oregon, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Nashville, Tennessee, United States
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Fort Sam Houston, Texas, United States
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Lubbock, Texas, United States
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Salem, Virginia, United States
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Adelaide, , Australia
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Camperdown, , Australia
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Clayton, , Australia
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Darlinghurst, , Australia
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Heidelberg, , Australia
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Hobart, , Australia
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Kogarah, , Australia
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Liverpool, , Australia
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Nedlands, , Australia
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Westmead, , Australia
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Linz, , Austria
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Salzburg, , Austria
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Wels, , Austria
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Antwerp, , Belgium
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Bruges, , Belgium
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La Louvière, , Belgium
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Curitiba, , Brazil
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Florianópolis, , Brazil
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Goiânia, , Brazil
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Passo Fundo, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Ribeirão Preto, , Brazil
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Rio de Janeiro, , Brazil
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São Paulo, , Brazil
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Vancouver, British Columbia, Canada
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Toronto, CA, Canada
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Winnipeg, Manitoba, Canada
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London, Ontario, Canada
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Lévis, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Ottawa, , Canada
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Toronto, , Canada
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Beijing, , China
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Beijing, , China
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Changchun, , China
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Chengdu, , China
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Guangzhou, , China
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Hangzhou, , China
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Hangzhou, , China
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Harbin, , China
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Jinan, , China
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Luoyang, , China
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Nanchang, , China
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Nanning, , China
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Shanghai, , China
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Shanghai, , China
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Shenyang, , China
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Shenyang, , China
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Shijiazhuang, , China
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Suzhou, , China
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Tianjin, , China
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Tianjin, , China
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Wuhan, , China
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Wuhan, , China
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Xiamen, , China
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Zhengzhou, , China
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Brno, , Czechia
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Hradec Králové, , Czechia
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Ostrava - Poruba, , Czechia
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Pilsen, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Brest, , France
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Caen, , France
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Marseille, , France
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Montpellier, , France
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Nantes, , France
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Pessac, , France
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Pierre-Bénite, , France
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Rennes, , France
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Toulouse, , France
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Bamberg, , Germany
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Berlin, , Germany
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Dresden, , Germany
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Homburg, , Germany
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Neumünster, , Germany
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Bangalore, , India
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Delhi, , India
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Kochi, , India
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Mumbai, , India
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Nashik, , India
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Nashik, , India
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Pune, , India
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Afula, , Israel
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Ashdod, , Israel
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Beersheba, , Israel
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Haifa, , Israel
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Haifa, , Israel
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Haifa, , Israel
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Holon, , Israel
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Jerusalem, , Israel
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Jerusalem, , Israel
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Nahariya, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Tel Aviv, , Israel
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Ẕerifin, , Israel
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Bari, , Italy
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Bergamo, , Italy
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Bologna, , Italy
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Florence, , Italy
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Genova, , Italy
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Meldola, , Italy
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Milan, , Italy
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Milan, , Italy
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Novara, , Italy
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Palermo, , Italy
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Pavia, , Italy
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Pisa, , Italy
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Ravenna, , Italy
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Reggio Emilia, , Italy
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Roma, , Italy
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Roma, , Italy
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Siena, , Italy
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Torino, , Italy
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Tricase, , Italy
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Venezia, , Italy
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Chiba, , Japan
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Chūōku, , Japan
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Fukuoka, , Japan
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Itabashi-ku, , Japan
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Kahoku-gun, , Japan
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Kashiwa, , Japan
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Kobe, , Japan
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Kōtoku, , Japan
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Kumamoto, , Japan
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Kyoto, , Japan
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Matsuyama, , Japan
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Nagasaki, , Japan
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Nagoya, , Japan
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Nagoya, , Japan
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Niigata, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Sapporo, , Japan
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Sendai, , Japan
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Shimotsuke-shi, , Japan
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Tsu, , Japan
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Chihuahua City, , Mexico
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Monterrey, , Mexico
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Gdansk, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Braga, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Matosinhos Municipality, , Portugal
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Porto, , Portugal
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Porto, , Portugal
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Vila Nova de Gaia, , Portugal
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Chelyabinsk, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Busan, , South Korea
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Busan, , South Korea
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Goyang-si, , South Korea
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Jeonju, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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Alcalá de Henares, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Gijón, , Spain
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L'Hospitalet de Llobregat, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Palma, , Spain
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Pamplona, , Spain
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Pozuelo de Alarcón, , Spain
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Salamanca, , Spain
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Seville, , Spain
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Valencia, , Spain
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Kaohsiung City, , Taiwan
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Tainan, , Taiwan
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Tainan, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan, , Taiwan
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Balçova, , Turkey (Türkiye)
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Edirne, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Kayseri, , Turkey (Türkiye)
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Mersin, , Turkey (Türkiye)
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Samsun, , Turkey (Türkiye)
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Trabzon, , Turkey (Türkiye)
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Cherkasy, , Ukraine
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Khmelnytskyi, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Lviv, , Ukraine
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Mykolayiv, , Ukraine
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Zaporizhzhia, , Ukraine
Countries
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Other Identifiers
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2019-001755-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D8227C00001
Identifier Type: -
Identifier Source: org_study_id