Spots Global Cancer Trial Database for A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
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Trial Identification
Brief Title: A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Official Title: A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Study ID: NCT05023980
Study Description
Brief Summary: The purpose of this study is to compare the efficacy and safety of pirtobrutinib (LOXO-305; Arm A) compared to BR (Arm B) in patients with CLL/SLL who have not been treated. Participation could last up to five years.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
California Research Institute, Los Angeles, California, United States
Innovative Clinical Research Institute, Whittier, California, United States
Oncology-Hematology Associates of West Broward, Tamarac, Florida, United States
Central Maine Medical Center, Lewiston, Maine, United States
Ascension St. John Hospital, Grosse Pointe Woods, Michigan, United States
New Jersey Center for Cancer Research, Brick, New Jersey, United States
Clinical Research Alliance, Inc., Westbury, New York, United States
Liverpool Hospital, Liverpool, New South Wales, Australia
Westmead Hospital, Wentworthville, New South Wales, Australia
Peninsula Private Hospital, Frankston, Victoria, Australia
Uniklinikum Salzburg, Salzburg, , Austria
Klinik Ottakring, Vienna, , Austria
Centro Integrado de Oncologia de Curitiba, Curitiba, Paraná, Brazil
Instituto do Câncer - Hospital São Vicente de Paulo, Passo Fundo, Rio Grande Do Sul, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, Rio Grande Do Sul, Brazil
Centro Gaucho Integrado - Mae de Deus Center, Porto Alegre, Rio Grande Do Sul, Brazil
Hemocentro Unicamp, Campinas, São Paulo, Brazil
Fundação Doutor Amaral Carvalho, Jaú, São Paulo, Brazil
UMHAT "Sveti Georgi" EAD, Plovdiv, , Bulgaria
UMHAT 'Sv. Ivan Rilski', EAD, Sofia, , Bulgaria
"SHATHD" EAD, Sofia, Sofia, , Bulgaria
UMHAT - Prof. Dr. Stoyan Kirkovich" AD, Stara Zagora, , Bulgaria
Anhui Provincial Cancer Hospital, Hefei, Anhui, China
Peking University First Hospital, Beijing, Beijing, China
Peking University Third Hospital, Beijing, Beijing, China
Cancer Center of Guangzhou Medical University, Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, China
Hunan Cancer Hospital, Changsha, Hunan, China
The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
Shengjing Hospital of China Medical University, Shenyany, Liaoning, China
Jiangsu Province Hospital, Nanjing, Nanjing, China
Shanghai Tongren Hospital, Changning District, Shanghai, China
West China Hospital of Sichuan University, Chengdu, Sichuan, China
Institute of hematology&blood disease hospital, Tianjin, Tianjin, China
Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, China
The First People's Hospital of Hangzhou Linping District, Hangzhou, Zhejiang, China
Beijing Hospital, Beijing, , China
Chongqing Cancer Hospital, Chongqing, , China
Hainan General Hospital, Haikou, , China
Henan Cancer Hospital, Zhengzhou, , China
Fakultni nemocnice Brno, Brno, , Czechia
Fakultni nemocnice Hradec Kralove, Hradec Kralove, , Czechia
Fakultni nemocnice Kralovske Vinohrady, Praha 10, , Czechia
Vseobecna fakultni nemocnice v Praze, Praha 2, , Czechia
CHRU De Tours, Tours, Tours Cedex 9, France
CHD Vendee, La Roche-sur-Yon, Vendee, France
Hospitalier Le Mans, Le Mans, , France
Chu Nimes/Institut De Cancerologie Du Gard, Nimes, , France
Semmelweis Egyetem, Budapest, , Hungary
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Budapest, , Hungary
National Institute of Oncology, Budapest, , Hungary
Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum, Debrecen, , Hungary
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz, Nyíregyháza, , Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz, Székesfehérvár, , Hungary
Mater Misericordiae Hospital, Dublin 7, , Ireland
IRCCS - AOU di Bologna, Bologna, BO, Italy
Azienda Ospedaliero Universitaria Pisana, Pisa, PI, Italy
Irccs Crob, Rionero In Vulture, Potenza, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, , Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Brescia, , Italy
Azienda Ospedaliera Universitaria Careggi, Firenze, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, , Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milano, , Italy
ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C, Milano, , Italy
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo), Monza, , Italy
Azienda Ospedale Maggiore Della Carita, Novara, , Italy
Azienda Ospedaliera Vincenzo Cervello, Palermo, , Italy
Istituto di Ematologia-C.R.E.O. (Centro di Ricerche Emato-Oncologich), Perugia, , Italy
Ospedale Santa Maria delle Croci, Ravenna, , Italy
Fondazione Policlinico Universitario Agostino Gemelli, Roma, , Italy
Azienda Ospedaliera Santa Maria Terni, Terni, , Italy
A.O.U. Citta' della Salute e della Scienza di Torino, Torino, , Italy
Azienda Ospedaliera Card. G. Panico, Tricase (Le), , Italy
Azienda sanitaria integrata università di Trieste, Trieste, , Italy
Nagoya Medical Center, Nagoya, Aichi, Japan
Nagoya City University Hospital, Nagoya, Aichi, Japan
Chiba Cancer Center, Chiba-Shi, Chiba, Japan
Fukui Medical University Hospital, Yoshida-Gun, Fukui, Japan
Our Lady of the Snow St. Mary's Hospital, Kurume-shi, Fukuoka-Ken, Japan
Hospital of University of Occupational and Environmental Health, Kitakyushu-shi, Fukuoka, Japan
NHO Mito Medical Center, Ibaraki-machi, HigaShiibaraki-Gun, Japan
Hokkaido University Hospital, Sapporo, Hokkaido, Japan
Kanagawa cancer center, Yokohama, Kanagawa, Japan
Kochi Medical School Hospital, Nankoku, Kochi, Japan
Tohoku University Hospital, Sendai-shi, Miyagi, Japan
Saitama Medical Center, Kawagoe, Saitama, Japan
Dokkyo Medical University - Koshigaya Hospital, Koshigaya, Saitama, Japan
University of Yamanashi Hospital, Chuo, Yamanshi, Japan
JCHO Kyushu Hospital, Fukoka-ken, , Japan
Kagoshima University Hospital, Kagoshima, , Japan
Okayama University Hospital, Okayama, , Japan
Gachon University Gil Medical Center, Namdong-gu, Incheon-gwangyeoksi [Incheon], Korea, Republic of
Seoul National University Hospital, Seoul, Seoul, Korea, Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Samsung Medical Center, Seoul, Seoul-teukbyeolsi [Seoul], 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
North Shore Hospital, Haematology Research, Takapuna, Auckland, New Zealand
Tauranga Hospital, Tauranga, Bay Of Plenty, New Zealand
Christchurch Hospital, Christchurch, , New Zealand
Middlemore Clinical Trials, Papatoetoe, , New Zealand
Wojewodzki Szpital Specjalistyczny, Iwaszkiewicza 5, Legnica, Poland
Klinika Hematoonkologii i Transplantacji Szpiku SPSK1 Lublin, Lublin, Lubelskie V, Poland
Uniwersyteckie Centrum Kliniczne, Gdańsk, 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, Kraków, , Poland
Centrum Onkologii Ziemi Lubelskiej, Lublin, , Poland
Szpital Wojewodzki w Opolu, Opole, , Poland
Nasz Lekarz Osrodek Badan Klinicznych, Toruń, , Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Cuire - Państwowy Instytut Badawczy, Warsaw, , Poland
Uniwersytecki Szpital Kliniczny Klinika, Wrocław, , Poland
Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga), Braga, , Portugal
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria, Lisboa, , Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE, Porto, , Portugal
Hospital de Sao Joao E.P.E., Porto, , Portugal
Centro Hospitalar de Vila Nova de Gaia, Vila Nova De Gaia, , Portugal
Spitalul Clinic Municipal Filantropia Craiova, Craiova, Dolj, Romania
Spitalul Clinic Colentina, Bucuresti, , Romania
Institutul Clinic Fundeni - Centrul de Hematologie si Transplant Medular, Bucuresti, , Romania
Spitalul Clinic Coltea, Bucuresti, , Romania
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca, Cluj-Napoca, , Romania
Institutului Regional de Oncologie IASI, Iasi, , Romania
Spitalul Clinic Judetean De Urgenta Oradea, Oradea, , Romania
Spitalul Clinic Judetean de Urgenta Targu Mures, Targu Mures, , Romania
Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary", Omsk, Omskaya Oblast, Russian Federation
Regional Oncology Dispensary, Penza, , Russian Federation
Academician I.P. Pavlov First St-Petersburg State Medical University, St-Petersburg, , Russian Federation
Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain
Hospital Universitario HM Sanchinarro, Madrid, Madrid, Comunidad De, Spain
Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Madrid, Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Duran I Reynals, L'Hospitalet De Llobregat, , Spain
Hospital Universitario Fundación Jiménez Díaz, Madrid, , Spain
Hospital Universitario Virgen del Rocío, Sevilla, , Spain
Hospital Universitario Virgen de Valme, Sevilla, , Spain
Chang Bing Show Chwan Memorial Hospital, Changhua, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital - Linkou, Taoyuan City, , Taiwan
Birmingham Heartlands Hospital, Birmingham, England, United Kingdom
New Cross Hospital, Wolverhampton, , United Kingdom
Contact Details
Name: Alex Levy, MD
Affiliation: Loxo Oncology
Role: STUDY_DIRECTOR
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