A Study of Nemtabrutinib vs Chemoimmunotherapy for Participants With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Without TP53 Aberrations (MK-1026-008, BELLWAVE-008)
研究单位：[1]Merck Sharp & Dohme LLC[2]Hattiesburg Clinic Hematology/Oncology ( Site 5216),Hattiesburg,Mississippi,United States,39401[3]Medical Oncology Associates, PS ( Site 5206),Spokane,Washington,United States,99208[4]Royal Adelaide Hospital ( Site 1105),Adelaide,South Australia,Australia,5000[5]Hospital Amaral Carvalho-Centro de Pesquisas ( Site 1304),Jaú,Sao Paulo,Brazil,17210-120[6]ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 1308),São Paulo,Sao Paulo,Brazil,01246-000[7]Hospital Paulistano-Americas Oncologia ( Site 1302),Sao Paulo,Brazil,01321-000[8]James Lind Centro de Investigación del Cáncer ( Site 1503),Temuco,Araucania,Chile,4800827[9]Biocenter ( Site 1507),Concepción,Biobio,Chile,4070196[10]IC La Serena Research ( Site 1506),La Serena,Coquimbo,Chile,1720430[11]Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1509),Santiago,Region M. De Santiago,Chile,7500653[12]FALP-UIDO ( Site 1500),Santiago,Region M. De Santiago,Chile,7500921[13]Peking University Third Hospital ( Site 1602),Beijing,Beijing,China,100091[14]Chongqing University Cancer Hospital ( Site 1605),Chongqing,Chongqing,China,400030[15]Chongqing Three Gorges Central Hospital ( Site 1609),Wanzhou,Chongqing,China,404199[16]Sun Yat-sen University Cancer Center ( Site 1608),Guangzhou,Guangdong,China,510060[17]Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 1607),Guangzhou,Guangdong,China,510515[18]The Affiliated Hospital of Guizhou Medical University ( Site 1625),Guiyang,Guizhou,China,550004[19]Hainan General Hospital ( Site 1603),Haikou,Hainan,China,570311[20]Henan Cancer Hospital-hematology department ( Site 1613),Zhengzhou,Henan,China,450008[21]Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1618),Wuhan,Hubei,China,430022[22]Tongji Hospital Tongji Medical,Science & Technology ( Site 1619),Wuhan,Hubei,China,430030[23]The First Affiliated Hospital of Soochow University-hematology department ( Site 1612),Suzhou,Jiangsu,China,215006[24]The First Affiliated Hospital of Nanchang University ( Site 1614),Nanchang,Jiangxi,China,330006[25]Jiangxi Provincial Cancer Hospital ( Site 1628),Nanchang,Jiangxi,China,330029[26]The First Hospital of Jilin University-Hematology ( Site 1621),Changchun,Jilin,China,130021[27]The First Affiliated Hospital of Xi'an Jiaotong University ( Site 1617),Xi'an,Shaanxi,China,710061[28]Shaanxi provincial people's hospital ( Site 1626),Xi'an,Shaanxi,China,710068[29]Shanxi Cancer Hospital ( Site 1629),Taiyuan,Shanxi,China,030000[30]Institute of hematology&blood disease hospital-Hematology ( Site 1600),Tianjin,Tianjin,China,300020[31]Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 1604),Tianjin,Tianjin,China,300060[32]The First Affiliated Hospital, Zhejiang University-Hematology ( Site 1611),Hangzhou,Zhejiang,China,310003[33]Clini Salud ( Site 1700),Envigado,Antioquia,Colombia,055422[34]Fundación Colombiana de Cancerología Clínica Vida ( Site 1707),Medellin,Antioquia,Colombia,050030[35]Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1704),Valledupar,Cesar,Colombia,200001[36]Oncologos del Occidente ( Site 1706),Pereira,Risaralda,Colombia,660001[37]Aalborg Universitetshospital, Syd ( Site 1901),Aalborg,Nordjylland,Denmark,9000[38]Odense Universitetshospital ( Site 1900),Odense,Syddanmark,Denmark,5000[39]Vejle Sygehus ( Site 1903),Vejle,Syddanmark,Denmark,7100[40]CELAN,S.A ( Site 2403),Guatemala,Guatemala,01010[41]Oncomedica-Guatemala ( Site 2402),Guatemala,Guatemala,01010[42]MEDI-K CAYALA ( Site 2401),Guatemala,Guatemala,01016[43]Queen Mary Hospital ( Site 2500),Hksar,Hong Kong[44]Fejér Megyei Szent György Egyetemi Oktató Kórház ( Site 2609),Székesfehérvár,Fejer,Hungary,8000[45]Markhot Ferenc Oktatokorhaz es Rendelointezet ( Site 2608),Eger,Heves,Hungary,3300[46]Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi
研究目的：
The purpose of this study is to evaluate the efficacy and safety of nemtabrutinib compared to investigator's choice of fludarabine plus cyclophosphamide plus rituximab (FCR) or bendamustine plus rituximab (BR) in participants with previously untreated CLL/SLL without 17p deletion and/or tumor protein (TP) 53 mutation. The primary hypothesis is that nemtabrutinib is superior to FCR/BR with respect to progression-free survival (PFS).
