Spots Global Cancer Trial Database for A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
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Trial Identification
Brief Title: A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Official Title: A Phase 3 Open-Label, Randomized Study of Fixed Duration Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab Versus Venetoclax and Rituximab in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-322)
Study ID: NCT04965493
Study Description
Brief Summary: The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. 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
Mayo Clinic Arizona, Phoenix, Arizona, United States
University of Arizona Cancer Center, Tucson, Arizona, United States
University of California Irvine Medical Center, Orange, California, United States
Scripps Mercy Hospital, San Diego, California, United States
Sharp Memorial Hospital, San Diego, California, United States
Providence Medical Foundation, Santa Rosa, California, United States
Hematology Oncology, P.C., Stamford, Connecticut, United States
Florida Cancer Specialists-Broadway, Fort Myers, Florida, United States
Cancer Specialists, LLC, Jacksonville, Florida, United States
Florida Cancer Specialists North, Saint Petersburg, Florida, United States
Florida Cancer Specialists Panhandle, Tallahassee, Florida, United States
Florida Cancer Specialists East, West Palm Beach, Florida, United States
Carle Clinic Association, P.C., Urbana, Illinois, United States
Central Care Cancer Center, Garden City, Kansas, United States
Pikeville Medical Center, Inc., Pikeville, Kentucky, United States
Hematology Oncology Clinic, Baton Rouge, Louisiana, United States
American Oncology Partners of Maryland, PA, Bethesda, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Mayo Clinic- Rochester, Rochester, Minnesota, United States
Central Care Cancer Center, Bolivar, Missouri, United States
Sarah Cannon Research Institute SCRI, Kansas City, Missouri, United States
Memorial Sloan Kettering Cancer Center, Basking Ridge, New Jersey, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center, Middletown, New Jersey, United States
Memorial Sloan Kettering Cancer Center, Montvale, New Jersey, United States
Carol G Simon Cancer Center, Morristown, New Jersey, United States
Memorial Sloan Kettering Cancer Center, Commack, New York, United States
Memorial Sloan Kettering Cancer Center, Harrison, New York, United States
Columbia University Medical Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Westchester Medical College, New York, New York, United States
SUNY Upstate Medical Center, Syracuse, New York, United States
Memorial Sloan Kettering Cancer Center, Uniondale, New York, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Novant Health Cancer Institute - Charlotte, Charlotte, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
The Ohio State University Wexner Medical Center, Columbus, Ohio, United States
Tennessee Oncology, Chattanooga, Tennessee, United States
SCRI - Tennessee Oncology, Nashville, Tennessee, United States
Houston Methodist Hospital Cancer Center, Houston, Texas, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Baylor Scott & White Health, Round Rock, Texas, United States
University Of Virginia, Charlottesville, Virginia, United States
Virginia Commonwealth University (VCU) Massey Cancer Center, Richmond, Virginia, United States
Swedish Cancer Institute, Seattle, Washington, United States
MultiCare Health System Institute for Research and Innovation, Spokane, Washington, United States
UW Cancer Center at ProHealth Care, Waukesha, Wisconsin, United States
Border Medical Oncology, Albury, New South Wales, Australia
Concord Repatriation General Hospital, Concord, New South Wales, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Flinders Medical Centre, Adelaide, South Australia, Australia
Royal Hobart Hospital, Hobart, Tasmania, Australia
St. Vincent's Hospital, Fitzroy, Victoria, Australia
Peninsula Private Hospital, Frankston, Victoria, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
Fiona Stanley Hospital, Murdoch, Western Australia, Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
Universitair Ziekenhuis Gent, Gent, , Belgium
Hôpital de Jolimont, Haine-Saint-Paul, , Belgium
CHU UCL Namur, Yvoir, , Belgium
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Foothills Medical Centre, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
BC Cancer Vancouver, Vancouver, British Columbia, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
CIUSSS du Centre Ouest de l'lle de Montreal, Montreal, Quebec, Canada
The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China
Peking University First Hospital, Beijing, Beijing, China
Fujian Cancer Hospital, Fuzhou, Fujian, China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, Guangdong, China
Zhongshan City People's Hospital, Zhongshan, Guangdong, China
Guangxi Medical University Cancer Hospital, Nanning, Guangxi, China
Henan Provincial People's Hospital, Zhengzhou, Henan, China
Tongji Hospital Affiliated to Tongji Medicine University, Wuhan City, Hubei, China
Union Hospital,Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Yichang Central People's Hospital, Yichang, Hubei, China
The Second Xiangya Hospital of Central South University, Changsha, Hunan, China
The First Affiliated Hospital Of University Of South China, Hengshan, Hunan, China
The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, China
Nantong Tumor Hospital, Nantong, Jiangsu, China
Wuxi People's Hospital, Wuxi, Jiangsu, China
Jiangxi Cancer Hospital, Nanchang, Jiangxi, China
Shengjing Hospital of China Medical University, Shenyang, Liaoning, China
Jiangsu Province Hospital, Nanjing, Nanjing, China
The Affiliated Hospital of Qingdao University, Qingdao City, Shandong, China
Shanghai Tongren Hospital, Changning District, Shanghai, China
Ruijin Hospital of Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, China
Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, China
The First People's Hospital of Yunnan Province, Kunming, Yunnan, China
First Affiliated Hosp of College of Med, Zhejiang University, Hangzhou, Zhejiang, China
Chongqing University Cancer Hospital, Chongqing, , 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
Rigshospitalet, Copenhagen, , Denmark
Institut de Cancérologie de Strasbourg Europe - ICANS, Strasbourg Cedex, Bas Rhin, France
Groupe Hospitalier Pitie-Salpetriere, Paris, Cedex 13, France
CHU de Nantes - Hôtel-Dieu, Nantes, Cedex 1, France
CHU Rennes - Hopital Pontchaillou, Rennes, Cedex 9, France
Institut Universitaire du Cancer de Toulouse- IUCT-O, Toulouse, Cedex 9, France
Centre Hospitalier Lyon Sud, Pierre-Bénite, Cedex, France
CHU de Limoges - Hôpital Dupuytren, Limoges, France Cédex, France
Hopital Saint Eloi, Montpellier Cedex 5, Herault, France
Hôpital Saint-Louis, Paris cedex 10, Paris, France
Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen, Rouen, Seine-Maritime, France
CHU Tours - Hôpital Bretonneau, Tours, Tours Cedex 9, France
CHU Poitiers - Hôpital la Milétrie, Politiers, Vienne, France
Centre Hospitalier du Mans, Le Mans, , France
CHU de Nancy - Hôpital de Brabois Adultes, Vandœuvre-lès-Nancy, , France
Muenchen Klinikum Schwabing, Muenchen, Bayern, Germany
Universitaetsmedizin Rostock, Rostock, Mecklenburg Vorpommern, Germany
Universitaetsklinikum Koeln, Koeln, Nordrhein Westfalen, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz, Mainz, Rheinland Pfalz, Germany
Klinikum Chemnitz gGmbH, Chemnitz, Sachsen, Germany
Universitaetsklinikum Leipzig AoeR, Leipzig, Sachsen, Germany
Charité Universitaetsmedizin Berlin - Campus Benjamin Franklin, Berlin, , Germany
Orszagos Onkologiai Intezet, Budapest, , Hungary
Debreceni Egyetem, Debrecen, , Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz, Kaposvar, , Hungary
Mater Misericordiae University Hospital, Dublin, , Ireland
University Hospital Waterford, Waterford, , Ireland
Bnai Zion Medical Center, Haifa, , Israel
Health Corporation of Galilee Medical Center, Naharia, , Israel
Rabin Medical Center-Beilinson Campus, Petah-Tikva, , Israel
Kaplan Medical Center, Reẖovot, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS, Bologna, , Italy
Azienda Ospedaliera di Catanzaro "Pugliese-Ciaccio", Catanzaro, , Italy
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna, Cona, , Italy
Azienda Ospedaliera Santa Croce e Carle, Cuneo, , Italy
Azienda Ospedaliera Universitaria Careggi, Firenze, , Italy
IRCCS Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori "Dino Amadori" - IRST, Meldola, , Italy
Ospedale San Raffaele, Milano, , Italy
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda), Milano, , Italy
A.O.U. Policlinico di Modena, Modena, , Italy
Ospedale Maggiore di Novara, Novara, , Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, Roma, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, , Italy
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, , Italy
Nagoya City University Hospital, Nagoya-shi, Aichi-Ken, Japan
NHO Nagoya Medical Center, Nagoya, Aichi, Japan
Hokkaido University Hospital, Sapporo, Hokkaido, Japan
Kanagawa cancer center, Yokohama, Kanagawa, Japan
Kochi Medical School Hospital, Nankoku, Kochi, Japan
University Hospital, Kyoto Prefectural University of Medicine, Kyoto-shi, Kyoto, Japan
Tohoku University Hospital, Sendai-shi, Miyagi, Japan
Kindai University Hospital, Osaka Sayama-shi, Osaka, Japan
Saitama Medical Center, Kawagoe-shi, Saitama-Ken, Japan
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
Cancer Institute Hospital of JFCR, Koto, Tokyo, Japan
Ome Municipal General Hospital, Ome, Tokyo, Japan
NTT Medical Center Tokyo, Shinagawa-Ku, Tokyo, Japan
University of Fukui Hospital, Fukui, , Japan
Kumamoto University Hospital, Kumamoto, , Japan
Okayama University Hospital, Okayama, , Japan
Severance Hospital, Yonsei University Health System, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
The Catholic University of Korea-Seoul St. Mary's Hospital, Seocho-Gu, Seoul, Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Szpitale Pomorskie spółka z ograniczoną odpowiedzialnością, Gdynia, Pomorskie, Poland
Pratia Onkologia Katowice, Katowice, , Poland
Pratia MCM Krakow, Krakow, , Poland
Instytut Hematologii i Transfuzjologii, Warszawa, , Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Łódź, , Poland
National Cancer Centre Singapore, Singapore, , Singapore
Singapore General Hospital, Singapore, , Singapore
Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain
Complejo Hospitalario de Toledo, Toledo, Castilla La Mancha, Spain
Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Madrid, Spain
Hospital Costa Del Sol, Marbella, Malaga, Spain
Hospital Universitario de La Princesa, Salamanca, Mandrid, Spain
Hospital Universitario Quironsalud Madrid, Madrid, Pozuelo De Alarcón, Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Universitario Infanta Leonor, Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz, Madrid, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Hospital Universitario Virgen del Rocío, Sevilla, , Spain
Hospital Universitari i Politecnic La Fe, Valencia, , Spain
Skane University Hospital, Lund, , Sweden
Karolinska Universitetssjukhuset, Huddinge, Stockholm, , Sweden
Akademiska Sjukhuset, Uppsala, , Sweden
Istituto Oncologico della Svizzera Italiana (IOSI)- Ente Ospedaliero Cantonale (EOC), Bellinzona, Ticino, Switzerland
Luzerner Kantonsspital - Luzern, Luzern, , Switzerland
Chang Gung Memorial Hospital - Linkou, Guei Shan Township, Taoyuan City, Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Derriford Hospital, Plymouth, Devon, United Kingdom
Leicester Royal Infirmary, Leicester, England, United Kingdom
Birmingham Heartlands Hospital, Birmingham, West Midlands, United Kingdom
St James's University Hospital, Leeds, West Yorkshire, United Kingdom
Churchill Hospital, Oxford, , United Kingdom
Royal Marsden Hospital, Surrey, , United Kingdom
Contact Details
Name: James Pauff, MD
Affiliation: Loxo Oncology
Role: STUDY_DIRECTOR
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