A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312)
ESCALADE
Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Acalabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects ≤75 Years With Previously Untreated Non-GCB DLBCL
2 other identifiers
interventional
611
22 countries
241
Brief Summary
Phase 3 randomized, double-blind, placebo-controlled, study assessing the efficacy and safety of acalabrutinib plus rituximab,cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) vs placebo plus R-CHOP in subjects ≤75 years of age with previously untreated non-germinal center diffuse large B-cell lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2020
Longer than P75 for phase_3
241 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2020
CompletedFirst Posted
Study publicly available on registry
August 28, 2020
CompletedStudy Start
First participant enrolled
October 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 22, 2027
March 31, 2026
March 1, 2026
6.4 years
August 25, 2020
March 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS) per the Lugano Classification for NHL in Arm A compared to Arm B
at every single visit up to 60 months
Secondary Outcomes (3)
Investigator-assessed event-free survival (EFS) for NHL in Arm A compared to Arm B
at every single visit up to 60 months
Overall survival in Arm A compared to Arm B
at every single visit up to 60 months
Percentage of Participants Who Achieved a Complete Response (CR) per 2014 Lugano Classification for NHL
at every single visit up to 60 months
Study Arms (2)
acalabrutinib + R-CHOP
EXPERIMENTALAcalabrutinib plus Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP)
placebo + R-CHOP
PLACEBO COMPARATORPlacebo plus Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Acerta Pharma BVlead
- AstraZenecacollaborator
Study Sites (243)
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, 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
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Zaporizhzhia, 69600, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Participant Care provider Investigator Outcomes assessor
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2020
First Posted
August 28, 2020
Study Start
October 8, 2020
Primary Completion (Estimated)
February 22, 2027
Study Completion (Estimated)
February 22, 2027
Last Updated
March 31, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.