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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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研究单位: [1]Loxo Oncology, Inc. [2],Korea, Republic of,03722 [3]Mayo Clinic Hospital,Phoenix,Arizona,United States,85054 [4]The University of Arizona Cancer Center,Tucson,Arizona,United States,85724 [5]University of California Irvine Medical Center,Orange,California,United States,92868 [6]Scripps Mercy Hospital,San Diego,California,United States,92103 [7]Providence Medical Foundation,Santa Rosa,California,United States,95403 [8]Stamford Hospital,Stamford,Connecticut,United States,06904 [9]Florida Cancer Specialists,Fort Myers,Florida,United States,33916 [10]Cancer Specialists of North Florida -St Augustine,Jacksonville,Florida,United States,32256 [11]Florida Cancer Specialists,Saint Petersburg,Florida,United States,33705 [12]Florida Cancer Specialists,Tallahassee,Florida,United States,32308 [13]Florida Cancer Specialists East,West Palm Beach,Florida,United States,33401 [14]Carle Cancer Center,Urbana,Illinois,United States,61801 [15]Pikeville Medical Center, Inc.,Pikeville,Kentucky,United States,41501 [16]Hematology Oncology Clinic,Baton Rouge,Louisiana,United States,70809 [17]American Oncology Partners of Maryland, PA,Bethesda,Maryland,United States,20817 [18]Mayo Clinic,Rochester,Minnesota,United States,55905 [19]Central Care Cancer Center,Bolivar,Missouri,United States,65613 [20]Research Medical Center,Kansas City,Missouri,United States,63142 [21]Memorial Sloan Kettering Cancer Center,Basking Ridge,New Jersey,United States,07920 [22]John Theurer Cancer Center at Hackensack University Medical Center,Hackensack,New Jersey,United States,07601 [23]Memorial Sloan Kettering Cancer Center,Middletown,New Jersey,United States,07748 [24]Memorial Sloan Kettering Cancer Center,Montvale,New Jersey,United States,07645 [25]Morristown Medical Center,Morristown,New Jersey,United States,07962 [26]Memorial Sloan Kettering Cancer Center,Commack,New York,United States,11725 [27]Memorial Sloan Kettering Cancer Center,Harrison,New York,United States,10604 [28]Memorial Sloan Kettering Cancer Center,New York,New York,United States,10021 [29]Columbia University Medical Center,New York,New York,United States,10032 [30]New York Medical College,New York,New York,United States,10532 [31]Memorial Sloan Kettering Cancer Center,Uniondale,New York,United States,11553 [32]Levine Cancer Institute,Charlotte,North Carolina,United States,28204 [33]Novant Cancer Institute Charlotte,Charlotte,North Carolina,United States,28204 [34]Duke University Medical Center,Durham,North Carolina,United States,27705 [35]The James Cancer Hospital,Columbus,Ohio,United States,43210 [36]Sarah Cannon Research Institute SCRI,Chattanooga,Tennessee,United States,37404 [37]Tennessee Oncology PLLC,Nashville,Tennessee,United States,37203 [38]Houston Methodist Cancer Center,Houston,Texas,United States,77030 [39]University of Texas MD Anderson Cancer Center,Houston,Texas,United States,77030 [40]MultiCare Health System Institute for Research and Innovation,Spokane,Washington,United States,99218 [41]The Richland Hospital,Waukesha,Wisconsin,United States,53188 [42]Border Medical Oncology,Albury,New South Wales,Australia,2640 [43]Royal Adelaide Hospital,Adelaide,South Australia,Australia,5000 [44]Flinders Medical Centre,Adelaide,South Australia,Australia,5042 [45]Royal Hobart Hospital,Hobart,Tasmania,Australia,7000 [46]St. Vincent's Hospital,Fitzroy,Victoria,Australia,3065 [47]Peninsula Private Hospital,Frankston,Victoria,Australia,3199 [48]The Alfred Hospital,Melbourne,Victoria,Australia,3004 [49]Fiona Stanley Hospital,Murdoch,Western Australia,Australia,6150 [50]Sir Charles Gairdner Hospital,Nedlands,Western Australia,Australia,6009 [51]Universitair Ziekenhuis Gent,Gent,Belgium,900 [52]Groupe Jolimont,Haine-Saint-Paul,Belgium,7100 [53]CHU UCL Namur site Godinne,Yvoir,Belgium,5530 [54]Foothills Medical Centre,Calgary,Alberta,Canada,T2N4N2 [55]Cross Cancer Institute,Edmonton,Alberta,Canada,T6G 1Z2 [56]BC Cancer Vancouver,Vancouver,British Columbia,Canada,V5Z4E6 [57]Sunnybrook Research Institute,Toronto,Ontario,Canada,M4N3M5 [58]Peking University First Hospital,Beijing,Beijing,China,100034 [59]Cancer Center of Guangzhou Medical University,Guangzhou,Guangdong,China,510000 [60]Henan Provincial People's Hospital,Zhengzhou,Henan,China,450003 [61]Wu Han Tongji Hospital,Wuhan City,Hubei,China,430030 [62]Wuhan Union Hospital,Wuhan,Hubei,China,430022 [63]Yichang Central People's Hospital,Yichang,Hubei,China,443003 [64]The First Affiliated Hospital Of University Of South China,Hengshan,Hunan,China,421001 [65]Nantong Tumor Hospital,Nantong,Jiangsu,China,226361 [66]Wuxi People's Hospital,Wuxi,Jiangsu,China,214023 [67]Shengjing Hospital of China Medical University,Shenyang,Liaoning,China,110022 [68]Jiangsu Province Hospital,Nanjing,Nanjing,China,210029 [69]The Affiliated Hospital of Qingdao University,Qingdao City,Shandong,China,266555 [70]Shanghai Tongren Hospital,Changning District,Shanghai,China,200050 [71]Tianjin Medical University Cancer Institute and Hospital,Tianjin,Tianjin,China,300060 [72]The First People's Hospital of Yunnan Province,Kunming,Yunnan,China,650034 [73]First Affiliated Hosp of College of Med, Zhejiang University,Hangzhou,Zhejiang,China,310003 [74]Chongqing Cancer Hospital,Chongqing,China,400030 [75]Fakultni nemocnice Brno,Brno,Czechia,62500 [76]Fakultni nemocnice Hradec Kralove,Hradec Kralove,Czechia,500 05 [77]Fakultni nemocnice Kralovske Vinohrady,Praha 10,Czechia,100 34 [78]Vseobecna fakultni nemocnice v Praze,Praha 2,Czechia,12808 [79]Rigshospitalet,Copenhagen,Denmark,2100 [80]Hopital de la Pitie Salpetriere,Paris,Cedex 13,France,75651 [81]CHU de Nantes - Hôtel-Dieu,Nantes,Cedex 1,France,44093 [82]Hôpital de Pontchaillou,Rennes,Cedex 9,France,35033 [83]L'Institut Universitaire du Cancer de Toulouse Oncopole,Toulouse,Cedex 9,France,31100 [84]Centre Hospitalier Lyon Sud,Pierre-Bénite,Cedex,France,69495 [85]Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen,Rouen,Seine-Maritime,France,76038 [86]CHRU De Tours,Tours,Tours Cedex 9,France,37044 [87]Centre Hospitalier du Mans,Le Mans,France,72000 [88]Hopital Saint Eloi,Montpellier Cedex,France,34295 [89]Pole Regionalde Cancérologie(CHU de Poitiers),Politiers,France,86021 [90]Chu De Nancy Hop D'Adultes De Brabois,Vandœuvre-lès-Nancy,France,54500 [91]University Hospital Waterford,Waterford,Ireland,X91 ER8E [92]Rabin Medical Center,Petah-Tikva,HaMerkaz,Israel [93]Bnai Zion Medical Center,Haifa,Israel,3339419 [94]Galilee Medical Center,Naharia,Israel,2210010 [95]Kaplan Medical Center,Reẖovot,Israel,76100 [96]Tel Aviv Sourasky Medical Center,Tel Aviv,Israel,6423906 [97]IRCCS - AOU di Bologna,Bologna,Italy,40138 [98]Azienda Ospedaliera Pugliese Ciaccio,Catanzaro,Italy,88100 [99]AOU Arcispedale Sant'Anna,Cona,Italy,44124 [100]Azienda Ospedaliera Universitaria Careggi,Firenze,Italy,50134 [101]Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori,Meldola,Italy,47014 [102]IRCCS Ospedale San Raffaele,Milano,Italy,20132 [103]A.O.U. di Modena,Modena,Italy,41124 [104]Azienda Ospedale Maggiore Della Carita,Novara,Italy,28100 [105]Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore,Roma,Italy,00168 [106]A.O.U. Citta' della Salute e della Scienza di Torino,Torino,Italy,10126 [107]Nagoya Medical Center,Nagoya,Aichi,Japan,460-0001 [108]Nagoya City University Hospital,Nagoya,Aichi,Japan,467-8602 [109]Hokkaido University Hospital,Sapporo,Hokkaido,Japan,060-8648 [110]Kanagawa cancer center,Yokohama,Kanagawa,Japan,241-8515 [111]Kochi Medical School Hospital,Nankoku,Kochi,Japan,783-8505 [112]Kyoto Furitsu Medical University Hospital,Kyoto-shi,Kyoto,Japan,602-8566 [113]Tohoku University Hospital,Sendai-shi,Miyagi,Japan,980-8574 [114]Kindai University Hospital,Osaka Sayama-shi,Osaka,Japan,589 8511 [115]Saitama Medical Center,Kawagoe,Saitama,Japan,350-8550 [116]National Cancer Center Hospital,Chuo-ku,Tokyo,Japan,104-0045 [117]Japanese Foundation for Cancer Research,Koto,Tokyo,Japan,135-8550 [118]NTT Medical Center Tokyo,Shinagawa-Ku,Tokyo,Japan,141-8625 [119]University of Fukui Hospital,Fukui,Japan,9101193 [120]Kumamoto University Hospital,Kumamoto,Japan,860-8556 [121]Okayama University Hospital,Okayama,Japan,700-8558 [122]The Catholic University of Korea-Seoul St. Mary's Hospital,Seocho-Gu,Seoul,Korea, Republic of,06591 [123]Seoul National University Hospital,Seoul,Korea, Republic of,03080 [124]Samsung Medical Center,Seoul,Korea, Republic of,06351 [125]Szpitale Pomorskie Sp. Z o. o.,Gdynia,Pomorskie,Poland,81-519 [126]Pratia Onkologia Katowice,Katowice,Poland,40519 [127]Pratia MCM Krakow,Krakow,Poland,30-510 [128]Wojewódzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii,Łódź,Poland,93510 [129]Singapore General Hospital,Singapore,Singapore,169608 [130]National Cancer Centre Singapore,Singapore,Singapore,169610 [131]Hospital Universitario de Toledo,Toledo,Castilla La Mancha,Spain,45004 [132]Hospital Puerta De Hierro,Majadahonda,Madrid,Spain,28222 [133]Hospital Costa Del Sol,Marbella,Malaga,Spain,29603 [134]Hospital Universitario Quironsalud Madrid,Madrid,Pozuelo De Alarcón,Spain,28223 [135]Hospital Universitari Vall d'Hebron,Barcelona,Spain,8035 [136]Hospital Universitario Fundación Jiménez Díaz,Madrid,Spain,28040 [137]Hospital Universitario Virgen del Rocío,Sevilla,Spain,41013 [138]Hospital Universitari I Politecnic La Fe,Valencia,Spain,46026 [139]Skanes Universitetssjukhus, Hematoloaimottagningen,Lund,Sweden,22185 [140]Kliniska forsknings- och utvecklingsenheten,Uppsala,Sweden,75185 [141]Ospedale Regionale Bellinzona e Valli,Bellinzona,Ticino,Switzerland,6500 [142]Luzerner Kantonsspital,Luzern,Switzerland,6000 [143]Chang Gung Memorial Hospital - Linkou,Guei Shan Township,Taoyuan City,Taiwan,333 [144]National Taiwan University Hospital,Taipei,Taiwan,10002 [145]Derriford Hospital,Plymouth,Devon,United Kingdom,PL6 8DH [146]Leicester Royal Infirmary,Leicester,England,United Kingdom,LE15WW [147]Churchill Hospital,Oxford,United Kingdom,OX3 7LJ

关键词: BTKi Hematologic Disease Lymphoma non-Hodgkin's B-cell

研究目的:
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.

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