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Brief Title: A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Official Title: A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-314)
Study ID: NCT05254743
Brief Summary: The purpose of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL. Participants may or may not have already had treatment for their cancer. Participation could last up to six years.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Genesis Cancer Center, Hot Springs, Arkansas, United States
Pacific Cancer Medical Center, Inc, Anaheim, California, United States
Alta Bates Summit Medical Center, Berkeley, California, United States
TOI Clinical Research, Cerritos, California, United States
Stanford School of Medicine-Cancer Clinical Trials Office, Palo Alto, California, United States
Eisenhower Army Medical Center, Rancho Mirage, California, United States
Sharp Memorial Hospital, San Diego, California, United States
California Cancer Associates for Research and Excellence, San Marcos, California, United States
Eastern Connecticut Hematology/Oncology Assoc., Norwich, Connecticut, United States
Asclepes Research Centers Florida, Brooksville, Florida, United States
Florida Cancer Specialists, Fort Myers, Florida, United States
Cancer Specialists of North Florida -St Augustine, Jacksonville, Florida, United States
Lakeland Regional Health Systems Inc, Lakeland, Florida, United States
Florida Cancer Specialists, Saint Petersburg, Florida, United States
Florida Cancer Specialists East, West Palm Beach, Florida, United States
Summit Cancer Care, P.C., Savannah, Georgia, United States
Baptist Healthcare System, Inc., Louisville, Kentucky, United States
Hematology Oncology Clinic, Baton Rouge, Louisiana, United States
Tulane Cancer Center Office of Clinical Research, New Orleans, Louisiana, United States
American Oncology Partners of Maryland, PA, Bethesda, Maryland, United States
TidalHealth Peninsula Regional, Inc., Salisbury, Maryland, United States
St. Vincent Frontier Cancer Center, Billings, Montana, United States
Westchester Medical Center, Hawthorne, New York, United States
Novant Cancer Institute Charlotte, Charlotte, North Carolina, United States
The James Cancer Hospital, Columbus, Ohio, United States
Cancer Care Associates of York, York, Pennsylvania, United States
Lifespan Cancer Institute, Providence, Rhode Island, United States
Prisma Health Cancer Institute, Greenville, South Carolina, United States
Sarah Cannon Research Institute SCRI, Chattanooga, Tennessee, United States
Kelsey Research Foundation, Houston, Texas, United States
Houston Methodist Hospital Cancer Center, Houston, Texas, United States
Lumi Research, Kingwood, Texas, United States
Baylor Scott & White Health, Round Rock, Texas, United States
Virginia Cancer Institute, Richmond, Virginia, United States
Summit Cancer Treatment Center, Spokane, Washington, United States
MultiCare Health System Institute for Research and Innovation, Spokane, Washington, United States
Hospital Privado De Comunidad, Mar Del Plata, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires, ABB, Ciudad Autónoma De Buenos Aire, Argentina
Instituto Alexander Fleming, Ciudad Autonoma Buenos Aires, , Argentina
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares, Santa Fe, , Argentina
Sunshine Hospital, St Albans, Victoria, Australia
One Clinical Research, Nedlands, Western Australia, Australia
The Perth Blood Institute, West Perth, , Australia
Ordensklinikum Linz, Linz, Oberösterreich, Austria
Hanusch Krankenhaus, Vienna, , Austria
VITAZ, Sint-Niklaas, Oost-Vlaanderen, Belgium
AZ Delta, Roeselare, West Flanders, Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, , Belgium
Centro Integrado de Oncologia de Curitiba, Curitiba, Paraná, Brazil
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer, Curitiba, Paraná, Brazil
Instituto do Câncer - Hospital São Vicente de Paulo, Passo Fundo, Rio Grande Do Sul, Brazil
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital Mae de Deus, Porto Alegre, Rio Grande Do Sul, Brazil
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu, Botucatu, Sao Paulo, Brazil
Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMP, Campinas, Sao Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto, Sao Jose Rio Preto, Sao Paulo, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos, Barretos, São Paulo, Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFMRP, Ribeirão Preto, São Paulo, Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia, Santo André, São Paulo, Brazil
Hospital Uopeccan - Centro de Pesquisa Clinica, Cascavel, , Brazil
Hospital Beneficência Portuguesa de São Paulo, Sao Paulo, , Brazil
Hospital Santa Marcelina, Sao Paulo, , Brazil
Hospital das Clínicas da Faculdade de Medicina da USP, São Paulo, , Brazil
Cancer Care Manitoba, Winnipeg, Manitoba, Canada
Royal Victoria Regional Health Centre, Barrie, Ontario, Canada
Hopital de L'Enfant Jesus, Québec, , Canada
Sociedad de Investigaciones Médicas Limitada, Temuco, IX Región, Chile
CeCim Biocinetic, Santiago, Región Metropolitana, Chile
Centro de Estudios Clinicos SAGA, Providencia, Santiago, Chile
Centro de Investigaciones Clínicas Viña del Mar (CIC), Viña del Mar, Valparaíso, Chile
Anhui Provincial Hospital, Hefei, Anhui, China
The Second Hospital of Anhui Medical University, Hefei, Anhui, China
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
Southern Medical University Nanfang Hospital, Guangzhou, Guangdong, China
Guangxi Medical University Affiliated Tumor Hospital, Nanning, Guangxi, China
Wu Han Tongji Hospital, Wuhan City, Hubei, China
The 2nd Xiangya Hospital of Central South University, Changsha, Hunan, China
Hunan Cancer Hospital, Changsha, Hunan, China
The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
Jiangxi Provincial Cancer Hospital, Nanchang, Jiangxi, China
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Blood Institute of the Chinese Academy of Medical science, Tianjin, Tianjin, China
Tianjin Medical University General Hospital, Tianjin, Tianjin, China
The Affiliated Cancer Hospital of Xinjiang Medical university, Urumqi, Xinjiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
The Fourth Affiliated Hospital Zhejiang University School of Medicine, Yiwu, Zhejiang, China
Hainan General Hospital, Haikou, , China
First Affiliated Hosp of College of Med, Zhejiang University, Hangzhou, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, , China
Fakultni nemocnice Brno, Brno, , Czechia
Fakultni nemocnice Hradec Kralove, Hradec Kralove, , Czechia
Fakultni Nemocnice Ostrava, Ostrava-Poruba, , Czechia
Fakultni Nemocnice Plzen, Plzen - Lochotin, , Czechia
Fakultni nemocnice Kralovske Vinohrady, Praha 10, , Czechia
Vseobecna fakultni nemocnice v Praze, Praha 2, , Czechia
Hopital de la Pitie Salpetriere, Paris, Cedex 13, France
CHU de Nantes - Hotel Dieu, Nantes, Cedex 1, France
Hôpital de Pontchaillou, Rennes, Cedex 9, France
Centre Hospitalier Lyon Sud, Pierre Benite, Cedex, France
Centre Antoine Lacassagne, Nice, Nice Cedex 2, France
CHRU De Tours, Tours, Tours Cedex 9, France
CHD Vendee, La Roche sur Yon, , France
Centre Hospitalier du Mans, Le Mans, , France
Centre Hospitalier Universitaire (Limoges) (CHU DUPUYTREN 1), Limoges, , France
Centre Henri Becquerel, Rouen Cedex, , France
Universitaetsklinikum Ulm, Ulm, Baden, Germany
Uniklinik Köln, Kerpener, Köln, Germany
GEFOS (Gesellschaft für onkologische Studien) Dortmund mbH, Dortmund, Nordrhein Westfalen, Germany
Gemeinschaftspraxis Haematologie und Onkologie, Dresden, Sachsen Anhalt, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden, Dresden, Sachsen, Germany
Debreceni Egyetem, Debrecen, , Hungary
Markusovszky Egyetemi Oktatokorhaz, Szombathely, , Hungary
Hadassah Medical Center, Jerusalem, , Israel
Rabin Medical Center-Beilinson Campus, Petach-Tikva, , Israel
Chaim Sheba Medical Center, Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST, Meldola, Forlì-Cesena, Italy
A.O.U. Citta' della Salute e della Scienza di Torino, Torino, Otago, Italy
Fondazione del Piemonte per l'Oncologia IRCCS Candiolo, Candiolo, Torino, Italy
Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo, Alessandria, , Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS, Bologna, , Italy
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico, Milano, , Italy
IRCCS Ospedale San Raffaele, Milano, , Italy
IEO Istituto Europeo di Oncologia, Milano, , Italy
Azienda Unita Sanitaria Locale di Reggio Emilia, Reggio Emilia, , Italy
Centro Ricerche Cliniche di Verona s.r.l., Verona, , Italy
Tokai University Hospital- Isehara Campus, Isehara, Kanagawa, Japan
Kumamoto University Hospital, Kumamoto, , Japan
Yamagata University Hospital, Yamagata, , Japan
Seoul National University Hospital, Seoul, Seoul, Korea, Korea, Republic of
The Catholic University of Korea-Seoul St. Mary's Hospital, Seocho-Gu, Seoul, Korea, Republic of
Inje Univ Busan Paik Hospital, Busan, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
P3 Research, Newtown, Wellington, New Zealand
Dunedin Hospital, Dunedin, , New Zealand
Waikato Hospital, Hamilton, , New Zealand
Middlemore Hospital, Otahuhu, , New Zealand
Uniwersyteckie Centrum Kliniczne, Gdansk, Pomorskie, Poland
Centrum Medyczne Pratia Poznan, Skorzewo, Poznan, Poland
KO-MED Centra Kliniczne, Biała Podlaska, , Poland
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w BydgoszczyKlinika Hematologii, Bydgoszcz, , Poland
Pratia Onkologia Katowice, Katowice, , Poland
Pratia MCM Krakow, Krakow, , Poland
Klinika Hematoonkologii i Transplantacji Szpiku, Lublin, , Poland
Szpital Wojewodzki w Opolu, Opole, , Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu Klinika Hematologii, Wrocław, , Poland
Institut Català d'Oncologia de Girona (ICO Girona), Girona, Cataluna, Spain
Hospital Germans Trias i Pujol, Badalona, Catalunya [Cataluña], Spain
Hospital Universitari Vall d'Hebron, Barcelona, Cataluña, Spain
Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Madrid, Comunidad De, Spain
Hospital Costa Del Sol, Marbella, Malaga, Spain
Hospital De Navarra, Pamplona, Navarra, Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Duran i Reynals, L'Hospitalet de Llobregat, , Spain
Hospital De Gran Canaria Dr. Negrin, Las Palmas de Gran Canaria, , Spain
Clinica Universitaria De Navarra, Madrid, , Spain
Hospital Universitario Infanta Leonor, Madrid, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Universitario Marqués de Valdecilla, Santander, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Hospital Universitario Virgen Del Rocio, Sevilla, , Spain
Chang Gung Memorial Hospital - Chiayi, Putz, Chiayi Hsien, Taiwan
Chang Bing Show Chwan Memorial Hospital, Changhua, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
Koo Foundation Sun Yan-Sen Cancer Center, Taipei, , Taiwan
Ankara University Medicine Hospital, Mamak, Ankara, Turkey
9 Eylul University Hospital, Balçova, İzmir, Turkey
Ege University Medical Faculty, Bornova, Izmir, Turkey
Gazi University Faculty of Medicine, Ankara, Yenimahalle, Turkey
Koc University American Hospital, Istanbul, , Turkey
Acıbadem Maslak Hastanesi, Istanbul, , Turkey
Istanbul University Istanbul Medical Faculty, Istanbul, , Turkey
Bristol Haematology and Oncology Centre, Bristol, Bristol, City Of, United Kingdom
Castle Hill Hospital, Hull, East Riding Of Yorkshire, United Kingdom
Leicester Royal Infirmary, Leicester, Leicestershire, United Kingdom
St Bartholomew's Hospital, London, London, City Of, United Kingdom
Singleton Hospital, Swansea, , United Kingdom
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