- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00332202
PRELUDE: Studie om de preventie van terugval bij lymfoom te onderzoeken met behulp van dagelijkse Enzastaurin
6 september 2018 bijgewerkt door: Eli Lilly and Company
Een klinische fase 3-studie om de preventie van terugval bij lymfoom te onderzoeken met behulp van dagelijkse Enzastaurin
Deze klinische onderzoeksstudie is bedoeld om de preventie van terugval te onderzoeken bij patiënten met diffuus grootcellig B-cellymfoom (DLBCL) die dagelijks enzastaurine gebruiken.
Dit is een gerandomiseerde studie die Enzastaurin vergelijkt met Placebo (schijnbehandeling), de kans om Enzastaurin te krijgen is 2 op 1.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
758
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Australian Capital Territory
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Garran, Australian Capital Territory, Australië, 2605
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New South Wales
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Gosford, New South Wales, Australië, 2250
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Northern Territory
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Casuarina, Northern Territory, Australië, 0811
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Queensland
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Woolloongabba, Queensland, Australië, 4102
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Victoria
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Heidelberg, Victoria, Australië, 3084
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Prahran, Victoria, Australië, 3181
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Western Australia
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Nedlands, Western Australia, Australië, 6009
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Brugge, België, 8000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Brussels, België, 1000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Gent, België, 9000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Leuven, België, 3000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Roeselare, België, 8800
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Belo Horizonte, Brazilië, 30380-490
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Campinas, Brazilië, 13083970
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Goiania, Brazilië, 74075040
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Rio De Janeiro, Brazilië, 22260020
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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São Paulo, Brazilië, 01223001
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Toronto, Ontario, Canada, M5G 2M9
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Quebec
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Montreal, Quebec, Canada, H3T 1E2
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Beijing, China, 100083
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Chengdu, China, 610041
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Guang Zhou, China, 510080
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hangzhou, China, 310003
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nanjing, China, 210029
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Shanghai, China, 200032
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Suzhou, China, 215006
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Herlev, Denemarken, 2730
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Odense, Denemarken, 5000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Berlin, Duitsland, 13353
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Chemnitz, Duitsland, 09113
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Erlangen, Duitsland, 91054
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Frankfurt, Duitsland, D-65929
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Giessen, Duitsland, 35392
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hamburg, Duitsland, 20099
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Homburg, Duitsland, 66421
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kassel, Duitsland, 34125
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Mainz, Duitsland, 55131
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Muenchen, Duitsland, 81675
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Helsinki, Finland, 00290
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Avignon, Frankrijk, 84902
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bayonne, Frankrijk, 64109
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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La Roche Sur Yon, Frankrijk, 85925
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Le Mans, Frankrijk, 72000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nantes, Frankrijk, 44202
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nice, Frankrijk, 06202
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nimes, Frankrijk, 30029
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pessac, Frankrijk, 33604
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Rennes, Frankrijk, 35033
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Vandoeuvre Les Nancy, Frankrijk, 54511
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Athens, Griekenland, 11527
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Haidari/Athens, Griekenland, 12462
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Thessaloniki, Griekenland, 54007
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Budapest, Hongarije, 1122
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Miskolc, Hongarije, 3529
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Mumbai, Indië, 400 026
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New Delhi, Indië, 110017
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pune, Indië, 411004
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Secunderabad, Indië, 500003
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Trivandrum, Indië, 695 011
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Aviano, Italië, 33081
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bergamo, Italië, 24128
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bologna, Italië, 40138
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Milano, Italië, 20162
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pisa, Italië, 56100
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Reggio Emilia, Italië, 42100
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Rome, Italië, 00161
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Vicenza, Italië, 36100
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Aichi, Japan, 460-0001
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Fukuoka, Japan, 811-1395
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Gunma, Japan, 371-8511
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Kanagawa, Japan, 259-1193
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kyoto, Japan, 602-8566
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Mie, Japan, 514-8507
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Miyagi, Japan, 980-8574
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nagasaki, Japan, 852-8501
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Okayama, Japan, 710-8602
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Shiga, Japan, 524-8524
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tokyo, Japan, 141
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Daegu, Korea, republiek van, 700-721
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Goyang-Si, Korea, republiek van, 411-764
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Hwasun-Gun, Korea, republiek van, 519-809
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Seoul, Korea, republiek van, 138-736
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Col. Florida, Mexico, 01030
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Guadalajara, Mexico, 44280
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Mexico City, Mexico, 01120
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Monterrey, Mexico, 64710
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San Luis Potosi, Mexico, 78216
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Toluca, Mexico, 50180
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Lublin, Polen, 20-090
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Olsztyn, Polen, 10-228
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Poznan, Polen, 60-569
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Warsaw, Polen, 02-781
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Wroclaw, Polen, 50-367
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Coimbra, Portugal, 3000-075
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Lisbon, Portugal, 1649-035
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Santa Maria Da Feira, Portugal, 4520-211
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San Juan, Puerto Rico, 00918
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Hospitalet Llobregat, Spanje, 08907
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Madrid, Spanje, 28041
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Oviedo, Spanje, 33006
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Salamanca, Spanje, 37007
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Santander, Spanje, 39008
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Toledo, Spanje, 45004
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Valencia, Spanje, 46009
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Zaragoza, Spanje, 50009
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Changhua, Taiwan, 500
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Chiayi City, Taiwan, 600
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Kaohsiung, Taiwan, 807
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Liouying/Tainan, Taiwan, 736
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Neihu Taipei, Taiwan, 114
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Taichung, Taiwan, 404
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Tainan, Taiwan, 70403
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Taipei, Taiwan, 220
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Brno, Tsjechië, 62500
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Olomouc, Tsjechië, 775 20
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Prague, Tsjechië, 128 08
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London, Verenigd Koninkrijk, SE1 9RT
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Devon
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Plymouth, Devon, Verenigd Koninkrijk, PL6 8DH
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East Sussex
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Brighton, East Sussex, Verenigd Koninkrijk, BN2 5BE
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Kent
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Maidstone, Kent, Verenigd Koninkrijk, ME16 9QQ
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Scotland
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Aberdeen, Scotland, Verenigd Koninkrijk, AB25 2ZN
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Glasgow, Scotland, Verenigd Koninkrijk, G12 0YN
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Alaska
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Anchorage, Alaska, Verenigde Staten, 99508
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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California
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Los Angeles, California, Verenigde Staten, 90095
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Florida
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Orlando, Florida, Verenigde Staten, 32806
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Illinois
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Chicago, Illinois, Verenigde Staten, 60637
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Indiana
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Bloomington, Indiana, Verenigde Staten, 47402
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Indianapolis, Indiana, Verenigde Staten, 46202
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Iowa
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Iowa City, Iowa, Verenigde Staten, 52242
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kentucky
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Lexington, Kentucky, Verenigde Staten, 40536
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02115
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Minnesota
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Robbinsdale, Minnesota, Verenigde Staten, 55422
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Rochester, Minnesota, Verenigde Staten, 55905
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Missouri
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Columbia, Missouri, Verenigde Staten, 65201
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Saint Louis, Missouri, Verenigde Staten, 63131
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North Carolina
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Durham, North Carolina, Verenigde Staten, 27710
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Oklahoma
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Tulsa, Oklahoma, Verenigde Staten, 74136
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Pennsylvania
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Pittsburgh, Pennsylvania, Verenigde Staten, 15232
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Tennessee
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Memphis, Tennessee, Verenigde Staten, 38138
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Texas
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Houston, Texas, Verenigde Staten, 77030
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The Woodlands, Texas, Verenigde Staten, 77380
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Utah
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Salt Lake City, Utah, Verenigde Staten, 84103
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Washington
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Everett, Washington, Verenigde Staten, 98201
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Seattle, Washington, Verenigde Staten, 98104
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Vancouver, Washington, Verenigde Staten, 98686
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wisconsin
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Madison, Wisconsin, Verenigde Staten, 53792
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lund, Zweden, 221 85
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Umea, Zweden, 901 85
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Uppsala, Zweden, 75185
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusiecriteria:
- Klinische diagnose van diffuus grootcellig B-cellymfoom
- Onlangs voltooide R-CHOP-therapie en bereikte remissie
- Internationale Prognostische Index (IPI) score 3,4,5
- Minstens 18 jaar oud
- Akkoord gaan met studievervolgschema
Uitsluitingscriteria:
- Andere therapie dan R-CHOP hebben gekregen voor lymfoom
- Ernstige medische aandoening zoals infectie, tweede kanker, hartziekte
- Bestraling ontvangen voor meer dan één laesie
- Kan geen tabletten slikken
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: EEN
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1125 mg oplaaddosis daarna 500 mg, oraal, dagelijks, tot ziekteprogressie of maximaal 3 jaar
Andere namen:
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Placebo-vergelijker: B
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oraal, dagelijks
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Algehele ziektevrije overleving
Tijdsspanne: Basislijn tot gemeten progressieve ziekte of overlijden door welke oorzaak dan ook (tot 80,30 maanden)
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Totale ziektevrije overlevingstijd (DFS) wordt gedefinieerd als de tijd vanaf de datum van inschrijving voor het onderzoek tot de eerste datum van objectief bepaalde terugkeer van de ziekte (progressieve ziekte) of overlijden door welke oorzaak dan ook.
DFS werd beoordeeld volgens de aanbevelingen van de International Working Group.
Progressieve ziekte (PD) wordt gedefinieerd als een toename van ≥ 50% vanaf het laagste punt in de som van het product van de diameters (SPD) van een eerder geïdentificeerde abnormale knoop voor gedeeltelijke of non-responders, of het verschijnen van een nieuwe laesie tijdens of bij het einde van de therapie.
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Basislijn tot gemeten progressieve ziekte of overlijden door welke oorzaak dan ook (tot 80,30 maanden)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Ziektevrije overleving na 2 jaar
Tijdsspanne: Basislijn tot 2 jaar
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Ziektevrije overleving na 2 jaar (DFS2) wordt gedefinieerd als het percentage DFS na 2 jaar vanaf de datum van inschrijving in het onderzoek en wordt bepaald aan de hand van de verdeling van de totale DFS-tijden.
Ziektevrije overlevingspercentages na 2 jaar zullen worden geschat met behulp van de Kaplan-Meier-methode.
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Basislijn tot 2 jaar
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Overleven zonder gebeurtenissen
Tijdsspanne: Baseline tot objectieve PD, start van nieuwe therapie of overlijden door welke oorzaak dan ook (tot 76,81 maanden)
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Totale Event-Free Survival (EFS)-tijd wordt gedefinieerd als de tijd vanaf de datum van inschrijving voor het onderzoek tot de eerste datum van objectief bepaalde terugkeer van de ziekte (progressieve ziekte), instelling van een nieuwe kankerbehandeling of overlijden door welke oorzaak dan ook.
Progressieve ziekte (PD) wordt gedefinieerd als een toename van ≥ 50% vanaf het laagste punt in de som van het product van de diameters (SPD) van een eerder geïdentificeerde abnormale knoop voor gedeeltelijke of non-responders, of het verschijnen van een nieuwe laesie tijdens of bij het einde van de therapie.
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Baseline tot objectieve PD, start van nieuwe therapie of overlijden door welke oorzaak dan ook (tot 76,81 maanden)
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Gebeurtenisvrije overleving na 2 jaar
Tijdsspanne: Basislijn tot 2 jaar
|
Voorvalvrije overleving na 2 jaar (EFS2) wordt gedefinieerd als het percentage EFS na 2 jaar vanaf de datum van inschrijving in het onderzoek en wordt bepaald aan de hand van de verdeling van de totale EFS-tijden.
Gebeurtenisvrije overlevingspercentages na 2 jaar zullen worden geschat met behulp van de Kaplan-Meier-methode.
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Basislijn tot 2 jaar
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Algemeen overleven
Tijdsspanne: Basislijn tot datum van overlijden door welke oorzaak dan ook (tot 80,30 maanden)
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Totale overlevingstijd (OS) wordt gedefinieerd als de tijd vanaf de datum van inschrijving voor het onderzoek tot de datum van overlijden door welke oorzaak dan ook.
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Basislijn tot datum van overlijden door welke oorzaak dan ook (tot 80,30 maanden)
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Aantal deelnemers met tijdens de behandeling optredende bijwerkingen
Tijdsspanne: Eerste dosis tot 30 dagen na stopzetting van de studiebehandeling (tot 81,30 maanden)
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Aantal deelnemers met tijdens de behandeling optredende bijwerkingen.
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Eerste dosis tot 30 dagen na stopzetting van de studiebehandeling (tot 81,30 maanden)
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Kwaliteit van leven: verandering ten opzichte van baseline in functionele beoordeling van kankertherapie - Lymphoma (FACT-Lym) Score
Tijdsspanne: Basislijn, maand 2; Basislijn, maand 4; Basislijn, maand 6; Basislijn, maand 12; Basislijn, maand 18; Basislijn, maand 24; Basislijn, maand 36
|
De FACT-Lym beoordeelt de gezondheidsgerelateerde kwaliteit van leven (HRQoL) bij deelnemers met non-Hodgkin-lymfoom.
Het omvat de kankerspecifieke FACT-G (Algemeen) met 27 items, die fysiek, sociaal/gezins-, emotioneel en functioneel welzijn beoordeelt, plus een subschaal met 15 items die zorgen beoordeelt die specifiek zijn voor lymfoom.
Elk item wordt gescoord op een schaal van 0 (helemaal niet) tot 4 (zeer veel), wat een mogelijke score van 0-168 oplevert, waarbij hogere scores een betere GKvL vertegenwoordigen.
Deze analyse maakte gebruik van een mixed-effect model-analyse van herhaalde metingen (MMRM) van verandering ten opzichte van baseline-aanpassing voor baseline-covariaten.
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Basislijn, maand 2; Basislijn, maand 4; Basislijn, maand 6; Basislijn, maand 12; Basislijn, maand 18; Basislijn, maand 24; Basislijn, maand 36
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Wijziging ten opzichte van baseline in EuroQol-5D (EQ-5D)-score
Tijdsspanne: Basislijn, maand 6; Basislijn, maand 24; Basislijn, maand 33
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Het EQ-5D-instrument is een door deelnemers beoordeelde vragenlijst die wordt gebruikt om de gezondheidsstatus te evalueren.
De EQ-5D beoordeelt vijf dimensies (mobiliteit, zelfzorg, gebruikelijke activiteit, pijn/ongemak en angst/depressie) die deelnemers beoordelen op drie niveaus (geen probleem, enig probleem of extreem probleem), evenals de algemene gezondheidsstatus .
De vijf dimensies kunnen worden gecombineerd met behulp van landspecifieke gewichten om een schatting te maken van de algehele gezondheidsstatusscore.
De mogelijke waarden voor de score variëren van -0,594 (ernstige problemen in alle 5 de dimensies) tot 1 (geen probleem in alle dimensies) op een schaal waarbij 1 staat voor de best mogelijke gezondheidstoestand.
Deze analyse maakte gebruik van een mixed-effect model-analyse van herhaalde metingen (MMRM) van verandering ten opzichte van baseline in de EQ-5D voor de op de bevolking gebaseerde indexscore-aanpassing in het Verenigd Koninkrijk voor baseline-covariaten.
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Basislijn, maand 6; Basislijn, maand 24; Basislijn, maand 33
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Translationeel onderzoek: DFS-deelnemers met diffuus grootcellig B-cellymfoom (DLBCL) B-cellen in het kiemcentrum (GCB) versus B-cellen in het niet-kiemcentrum
Tijdsspanne: Baseline tot 24 maanden (2 jaar)
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Gerapporteerd zijn de DFS voor GCB- en niet-GCB-status.
DLBCL moleculaire subtypen van GCB/niet-GCB met behulp van het algoritme van Hans werden bepaald door eiwitexpressie door middel van immunohistochemie (IHC) kleuring werd gebruikt om moleculaire subtypekarakterisering van GCB en niet-GCB te beoordelen.
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Baseline tot 24 maanden (2 jaar)
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Translationeel onderzoek: DFS van deelnemers met diffuus grootcellig B-cellymfoom (DLBCL) Protein Kinase C-β2 (PKC-β2) expressie
Tijdsspanne: Basislijn tot 94,5 maanden
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Gerapporteerd zijn de DFS op basis van PKC-β2-eiwitexpressie.
Immunohistochemie (IHC)-kleuring werd uitgevoerd om de eiwitexpressie van PKC-β2 in het cytoplasma te beoordelen, gescoord voor het percentage gekleurde tumorcellen, en waarbij 50% positieve kleuring werd gebruikt als grenswaarde voor hoge/lage expressie (hoge expressie: >=50% kleuring, lage expressie: <50% kleuring).
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Basislijn tot 94,5 maanden
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Farmacokinetiek: gemiddelde steady-state concentratie (Cavg,ss) voor totaal analyt
Tijdsspanne: Maand 2, maand 4: Predosis
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Maand 2, maand 4: Predosis
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juni 2006
Primaire voltooiing (Werkelijk)
1 april 2013
Studie voltooiing (Werkelijk)
1 juli 2013
Studieregistratiedata
Eerst ingediend
30 mei 2006
Eerst ingediend dat voldeed aan de QC-criteria
30 mei 2006
Eerst geplaatst (Schatting)
1 juni 2006
Updates van studierecords
Laatste update geplaatst (Werkelijk)
10 september 2018
Laatste update ingediend die voldeed aan QC-criteria
6 september 2018
Laatst geverifieerd
1 september 2018
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 9823
- PRELUDE (Andere identificatie: Eli Lilly and Company)
- H6Q-MC-JCBJ (Andere identificatie: Eli Lilly and Company)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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