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)
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
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.