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) Summary 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 leukemia -cll/" >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).
View Eligibility Criteria Eligibility Criteria The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: Confirmed diagnosis of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) and active disease clearly documented to have a need to initiate therapy Has previously untreated CLL/SLL participants without tumor protein 53 (TP53) aberrations and documented 11q status and immunoglobulin heavy chain gene (IGHV) mutational status The ability to swallow and retain oral medication Exclusion Criteria: Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection Gastrointestinal dysfunction that may affect drug absorption (eg, gastric bypass surgery, gastrectomy) Known additional malignancy that is progressing or has required active treatment within the past 3 years, except basal cell carcinoma of skin, squamous cell carcinoma of skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potential curative therapy History of severe bleeding disorders Not adequately recovered from major surgery or has ongoing surgical complications
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There are 84 Locations for this study
Highlands Oncology Group ( Site 5205) Springdale Arkansas, 72762, United States
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Clermont Oncology Center ( Site 5224) Clermont Florida, 34711, United States
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Hattiesburg Clinic Hematology/Oncology ( Site 5216) Hattiesburg Mississippi, 39401, United States
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Medical Oncology Associates, PS ( Site 5206) Spokane Washington, 99208, United States
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Royal Adelaide Hospital ( Site 1105) Adelaide South Australia, 5000, Australia
Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1317) Curitiba Parana, 81520, Brazil
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Hospital Amaral Carvalho-Centro de Pesquisas ( Site 1304) Jaú Sao Paulo, 17210, Brazil
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ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 1308) São Paulo Sao Paulo, 01246, Brazil
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A. C. Camargo Cancer Center ( Site 1318) São Paulo Sao Paulo, 01509, Brazil
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Instituto Nacional de Câncer - INCA-Divisão de Pesquisa Clínica e Desenvolvimento Tecnológico HC1 ( Rio de Janeiro , 20231, Brazil
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Hospital Paulistano-Americas Oncologia ( Site 1302) Sao Paulo , 01321, Brazil
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James Lind Centro de Investigación del Cáncer ( Site 1503) Temuco Araucania, 48008, Chile
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Biocenter ( Site 1507) Concepción Biobio, 40701, Chile
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IC La Serena Research ( Site 1506) La Serena Coquimbo, 17204, Chile
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Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1509) Santiago Region M. De Santiago, 75006, Chile
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FALP-UIDO ( Site 1500) Santiago Region M. De Santiago, 75009, Chile
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Clínica Inmunocel ( Site 1511) Santiago Region M. De Santiago, 75802, Chile
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Peking University Third Hospital ( Site 1602) Beijing Beijing, 10009, China
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Chongqing University Cancer Hospital ( Site 1605) Chongqing Chongqing, 40003, China
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Chongqing University Three Gorges Hospital ( Site 1609) Chongqing Chongqing, 40400, China
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Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 1607) Guangzhou Guangdong, 51051, China
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Sun Yat-sen University Cancer Center ( Site 1608) Guangzhou Guangdong, 51070, China
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The Affiliated Hospital of Guizhou Medical University ( Site 1625) Guiyang Guizhou, 55000, China
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Hainan General Hospital ( Site 1603) Haikou Hainan, 57031, China
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Henan Cancer Hospital-hematology department ( Site 1613) Zhengzhou Henan, 45000, China
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Tongji Hospital Tongji Medical,Science & Technology ( Site 1619) Wuhan Hubei, 43000, China
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Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1618) Wuhan Hubei, 43001, China
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Xiangya Hospital Central South University-Hematology department ( Site 1616) Changsha Hunan, 41000, China
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Hunan Cancer Hospital ( Site 1615) Changsha Hunan, 41001, China
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The First Affiliated Hospital of Soochow University-hematology department ( Site 1612) Suzhou Jiangsu, 21503, China
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The First Affiliated Hospital of Nanchang University ( Site 1614) Nanchang Jiangxi, 33000, China
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Jiangxi Provincial Cancer Hospital ( Site 1628) Nanchang Jiangxi, 33002, China
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The First Hospital of Jilin University-Hematology ( Site 1621) Changchun Jilin, 13002, China
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The First Affiliated Hospital of Xi'an Jiaotong University ( Site 1617) Xi'an Shaanxi, 71006, China
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Shaanxi provincial people's hospital ( Site 1626) Xi'an Shaanxi, 71006, China
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Fudan University Shanghai Cancer Center ( Site 1606) Shanghai Shanghai, 20003, China
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Shanxi Cancer Hospital ( Site 1629) Taiyuan Shanxi, 03000, China
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Institute of hematology&blood disease hospital ( Site 1600) Tianjin Tianjin, 30002, China
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Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 1604) Tianjin Tianjin, 30006, China
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The First Affiliated Hospital, Zhejiang University-Hematology ( Site 1611) Hangzhou Zhejiang, 31000, China
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Clini Salud ( Site 1700) Envigado Antioquia, 05542, Colombia
Fundación Colombiana de Cancerología Clínica Vida ( Site 1707) Medellin Antioquia, 05003, Colombia
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Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1704) Valledupar Cesar, 20000, Colombia
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Oncologos del Occidente ( Site 1706) Pereira Risaralda, 66000, Colombia
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Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 1902) Aarhus Midtjylland, 8200, Denmark
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Aalborg Universitetshospital, Syd ( Site 1901) Aalborg Nordjylland, 9000, Denmark
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Odense Universitetshospital ( Site 1900) Odense Syddanmark, 5000, Denmark
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Vejle Sygehus ( Site 1903) Vejle Syddanmark, 7100, Denmark
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CELAN,S.A ( Site 2403) Guatemala , 01010, Guatemala
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Oncomedica-Guatemala ( Site 2402) Guatemala , 01010, Guatemala
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MEDI-K CAYALA ( Site 2401) Guatemala , 01016, Guatemala
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Queen Mary Hospital ( Site 2500) Hksar , , Hong Kong
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Fejér Megyei Szent György Egyetemi Oktató Kórház ( Site 2609) Székesfehérvár Fejer, 8000, Hungary
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Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet ( Site 2608) Eger Heves, 3300, Hungary
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Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór-Haematológia osztály ( Site 2602) Nyiregyhaza Szabolcs-Szatmar-Bereg, 4400, Hungary
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Hospital Sultanah Aminah ( Site 3203) Johor Bahru Johor, 80100, Malaysia
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Hospital Ampang ( Site 3202) Ampang Selangor, 68000, Malaysia
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Centro de Infusion Superare ( Site 3314) Ciudad de México Distrito Federal, 03100, Mexico
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Health Pharma Professional Research S.A. de C.V: ( Site 3301) Ciudad de México Distrito Federal, 03100, Mexico
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Centro de Investigacion Clinica Chapultepec ( Site 3309) Morelia Michoacan, 58260, Mexico
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Samodzielny Publiczny Szpital Kliniczny nr 1-Department of Haematooncology and Bone Marrow Transpla Lublin Lubelskie, 20-08, Poland
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Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( S Warszawa Mazowieckie, 02-78, Poland
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Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 3702) Gdansk Pomorskie, 80-95, Poland
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Pratia Onkologia Katowice ( Site 3705) Katowice Slaskie, 40-51, Poland
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Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S Kielce Swietokrzyskie, 25-73, Poland
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Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warmi-Oddzial Kliniczny Hematologii ( Site 37 Olsztyn Warminsko-mazurskie, 10-22, Poland
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Spitalul Clinic Colțea ( Site 4000) București Bucuresti, 03017, Romania
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Spitalul Clinic Colțea ( Site 4001) București Bucuresti, 03017, Romania
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Institutul Oncologic Cluj ( Site 4002) Cluj , 40001, Romania
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National Cancer Centre Singapore ( Site 4200) Singapore Central Singapore, 16858, Singapore
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Tan Tock Seng Hospital ( Site 4202) Singapore Central Singapore, 30843, Singapore
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Netcare Pretoria East Hospital-Albert Alberts Stem Cell Transplant Centre ( Site 4401) Centurion Gauteng, 0181, South Africa
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Wits Clinical Research ( Site 4403) Johannesburg Gauteng, 1864, South Africa
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Groote Schuur Hospital-Clinical Haematology ( Site 4400) Cape Town Western Cape, 7925, South Africa
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Haemalife ( Site 4407) Kuilsriver Western Cape, 7580, South Africa
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Constantiaberg Haematology ( Site 4408) Plumstead Western Cape, 7800, South Africa
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Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 4700) Kaohsiung , 83301, Taiwan
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National Cheng Kung University Hospital ( Site 4701) Tainan , 704, Taiwan
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National Taiwan University Hospital ( Site 4704) Taipei , 10022, Taiwan
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Mega Medipol-Hematology ( Site 4904) Stanbul Istanbul, 34214, Turkey
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Namik Kemal University Medical Faculty-Hematology ( Site 4912) Suleymanpasa Tekirdas, 59100, Turkey
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Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 4913) Ankara , 06100, Turkey
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TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 4906) Istanbul , 34722, Turkey
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Ege Universitesi Hastanesi ( Site 4902) İzmir , 35100, Turkey
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MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( S Cherkassy Cherkaska Oblast, 18009, Ukraine
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Communal non-profit enterprise "Regional clinical hospital o-Hematology Department ( Site 5113) Ivano-Frankivsk Ivano-Frankivska Oblast, 76008, Ukraine
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Nonprofit Organization National Cancer Institute ( Site 5103) Kyiv Kyivska Oblast, 03022, Ukraine
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Institute of Blood Pathology and Transfusion Medicine of National Aсademy of Medical Sciences of Ukr Lviv Lvivska Oblast, 79057, Ukraine
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National Research Center for Radiation Medicine of National Academy of Medical Sciences of Ukraine ( Kyiv , 03115, Ukraine
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Public Non-Profit Enterprise Kyiv City Clinical Hospital #9 -Hematology department #1 ( Site 5111) Kyiv , 04112, Ukraine
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