Spots Global Cancer Trial Database for 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)
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Trial Identification
Brief Title: 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)
Official Title: A Phase 3, Randomized Study to Compare the Efficacy and Safety of Nemtabrutinib Versus Chemoimmunotherapy for Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Without TP53 Aberrations
Study ID: NCT05624554
Study Description
Brief 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 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).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Highlands Oncology Group ( Site 5205), Springdale, Arkansas, United States
Clermont Oncology Center ( Site 5224), Clermont, Florida, United States
Hattiesburg Clinic Hematology/Oncology ( Site 5216), Hattiesburg, Mississippi, United States
Medical Oncology Associates, PS ( Site 5206), Spokane, Washington, United States
Royal Adelaide Hospital ( Site 1105), Adelaide, South Australia, Australia
Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1317), Curitiba, Parana, Brazil
Hospital Amaral Carvalho-Centro de Pesquisas ( Site 1304), Jaú, Sao Paulo, Brazil
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 1308), São Paulo, Sao Paulo, Brazil
A. C. Camargo Cancer Center ( Site 1318), São Paulo, Sao Paulo, Brazil
Instituto Nacional de Câncer - INCA-Divisão de Pesquisa Clínica e Desenvolvimento Tecnológico HC1 (, Rio de Janeiro, , Brazil
Hospital Paulistano-Americas Oncologia ( Site 1302), Sao Paulo, , Brazil
James Lind Centro de Investigación del Cáncer ( Site 1503), Temuco, Araucania, Chile
Biocenter ( Site 1507), Concepción, Biobio, Chile
IC La Serena Research ( Site 1506), La Serena, Coquimbo, Chile
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1509), Santiago, Region M. De Santiago, Chile
FALP-UIDO ( Site 1500), Santiago, Region M. De Santiago, Chile
Clínica Inmunocel ( Site 1511), Santiago, Region M. De Santiago, Chile
Peking University Third Hospital ( Site 1602), Beijing, Beijing, China
Chongqing University Cancer Hospital ( Site 1605), Chongqing, Chongqing, China
Chongqing University Three Gorges Hospital ( Site 1609), Chongqing, Chongqing, China
Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 1607), Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center ( Site 1608), Guangzhou, Guangdong, China
The Affiliated Hospital of Guizhou Medical University ( Site 1625), Guiyang, Guizhou, China
Hainan General Hospital ( Site 1603), Haikou, Hainan, China
Henan Cancer Hospital-hematology department ( Site 1613), Zhengzhou, Henan, China
Tongji Hospital Tongji Medical,Science & Technology ( Site 1619), Wuhan, Hubei, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1618), Wuhan, Hubei, China
Xiangya Hospital Central South University-Hematology department ( Site 1616), Changsha, Hunan, China
Hunan Cancer Hospital ( Site 1615), Changsha, Hunan, China
The First Affiliated Hospital of Soochow University-hematology department ( Site 1612), Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University ( Site 1614), Nanchang, Jiangxi, China
Jiangxi Provincial Cancer Hospital ( Site 1628), Nanchang, Jiangxi, China
The First Hospital of Jilin University-Hematology ( Site 1621), Changchun, Jilin, China
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 1617), Xi'an, Shaanxi, China
Shaanxi provincial people's hospital ( Site 1626), Xi'an, Shaanxi, China
Fudan University Shanghai Cancer Center ( Site 1606), Shanghai, Shanghai, China
Shanxi Cancer Hospital ( Site 1629), Taiyuan, Shanxi, China
Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 1604), Tianjin, Tianjin, China
Institute of hematology&blood disease hospital-Hematology ( Site 1600), Tianjin, Tianjin, China
The First Affiliated Hospital, Zhejiang University-Hematology ( Site 1611), Hangzhou, Zhejiang, China
Clini Salud ( Site 1700), Envigado, Antioquia, Colombia
Fundación Colombiana de Cancerología Clínica Vida ( Site 1707), Medellin, Antioquia, Colombia
Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1704), Valledupar, Cesar, Colombia
Oncologos del Occidente ( Site 1706), Pereira, Risaralda, Colombia
Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 1902), Aarhus, Midtjylland, Denmark
Aalborg Universitetshospital, Syd ( Site 1901), Aalborg, Nordjylland, Denmark
Odense Universitetshospital ( Site 1900), Odense, Syddanmark, Denmark
Vejle Sygehus ( Site 1903), Vejle, Syddanmark, Denmark
CELAN,S.A ( Site 2403), Guatemala, , Guatemala
Oncomedica-Guatemala ( Site 2402), Guatemala, , Guatemala
MEDI-K CAYALA ( Site 2401), Guatemala, , Guatemala
Queen Mary Hospital ( Site 2500), Hksar, , Hong Kong
Fejér Megyei Szent György Egyetemi Oktató Kórház ( Site 2609), Székesfehérvár, Fejer, Hungary
Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet ( Site 2608), Eger, Heves, Hungary
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór-Haematológia osztály ( Site 2602), Nyiregyhaza, Szabolcs-Szatmar-Bereg, Hungary
Hospital Sultanah Aminah ( Site 3203), Johor Bahru, Johor, Malaysia
Hospital Ampang ( Site 3202), Ampang, Selangor, Malaysia
Health Pharma Professional Research S.A. de C.V: ( Site 3301), Ciudad de México, Distrito Federal, Mexico
Centro de Investigacion Clinica Chapultepec ( Site 3309), Morelia, Michoacan, Mexico
Samodzielny Publiczny Szpital Kliniczny nr 1-Department of Haematooncology and Bone Marrow Transpla, Lublin, Lubelskie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( S, Warszawa, Mazowieckie, Poland
Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 3702), Gdansk, Pomorskie, Poland
Pratia Onkologia Katowice ( Site 3705), Katowice, Slaskie, Poland
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S, Kielce, Swietokrzyskie, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warmi-Oddzial Kliniczny Hematologii ( Site 37, Olsztyn, Warminsko-mazurskie, Poland
Spitalul Clinic Colțea ( Site 4000), București, Bucuresti, Romania
Spitalul Clinic Colțea ( Site 4001), București, Bucuresti, Romania
Institutul Oncologic Cluj ( Site 4002), Cluj, , Romania
National Cancer Centre Singapore ( Site 4200), Singapore, Central Singapore, Singapore
Tan Tock Seng Hospital ( Site 4202), Singapore, Central Singapore, Singapore
Netcare Pretoria East Hospital-Albert Alberts Stem Cell Transplant Centre ( Site 4401), Centurion, Gauteng, South Africa
Wits Clinical Research ( Site 4403), Johannesburg, Gauteng, South Africa
Groote Schuur Hospital-Clinical Haematology ( Site 4400), Cape Town, Western Cape, South Africa
Haemalife ( Site 4407), Kuilsriver, Western Cape, South Africa
Constantiaberg Haematology ( Site 4408), Plumstead, Western Cape, South Africa
Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 4700), Kaohsiung, , Taiwan
National Cheng Kung University Hospital ( Site 4701), Tainan, , Taiwan
National Taiwan University Hospital ( Site 4704), Taipei, , Taiwan
Mega Medipol-Hematology ( Site 4904), Stanbul, Istanbul, Turkey
Namik Kemal University Medical Faculty-Hematology ( Site 4912), Suleymanpasa, Tekirdas, Turkey
Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 4913), Ankara, , Turkey
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 4906), Istanbul, , Turkey
Ege Universitesi Hastanesi ( Site 4902), İzmir, , Turkey
MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( S, Cherkassy, Cherkaska Oblast, Ukraine
Communal non-profit enterprise "Regional clinical hospital o-Hematology Department ( Site 5113), Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine
Nonprofit Organization National Cancer Institute ( Site 5103), Kyiv, Kyivska Oblast, Ukraine
Institute of Blood Pathology and Transfusion Medicine of National Aсademy of Medical Sciences of Ukr, Lviv, Lvivska Oblast, Ukraine
National Research Center for Radiation Medicine of National Academy of Medical Sciences of Ukraine (, Kyiv, , Ukraine
Public Non-Profit Enterprise Kyiv City Clinical Hospital #9 -Hematology department #1 ( Site 5111), Kyiv, , Ukraine
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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