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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)
Sponsor: Merck Sharp & Dohme LLC
Summary
Researchers are looking for new ways to treat people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). CLL and SLL are types of blood cancer. Researchers want to know if people who take nemtabrutinib compared to those who take the standard treatments in this study will live longer without their cancer growing, spreading or returning (progression free survival).
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2023-03-16
Completion Date
2031-03-17
Last Updated
2026-03-16
Healthy Volunteers
No
Interventions
Nemtabrutinib
65 mg administered orally daily until disease progression, unacceptable toxicity, or discontinuation criteria met.
Fludarabine
25 mg/m\^2 administered via intravenous (IV) infusion on Days 1, 2, and 3 of each 28-day cycle up to 6 cycles.
Cyclophosphamide
250 mg/m\^2 administered via IV infusion on Days 1, 2, and 3 of each 28-day cycle up to 6 cycles.
Bendamustine
Administered via IV infusion on Days 1 and 2 of each 28-day cycle up to 6 cycles. The first dose is given as 70 to 90 mg/m\^2. Subsequent doses may be escalated up to 90 mg/m\^2, if applicable and as per local guidelines.
Rituximab
Administered as an IV infusion on Day 1 of each 28-day cycle. The initial dose is 375 mg/m\^2 (cycle 1) followed by 500 mg/m\^2 for remaining cycles.
Truxima
Administered as an IV infusion on Day 1 of each 28-day cycle. The initial dose is 375 mg/m\^2 (cycle 1) followed by 500 mg/m\^2 for remaining cycles.
Ruxience
Administered as an IV infusion on Day 1 of each 28-day cycle. The initial dose is 375 mg/m\^2 (cycle 1) followed by 500 mg/m\^2 for remaining cycles.
Riabni
Administered as an IV infusion on Day 1 of each 28-day cycle. The initial dose is 375 mg/m\^2 (cycle 1) followed by 500 mg/m\^2 for remaining cycles.
Locations (97)
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, Paraná, Brazil
Hospital Amaral Carvalho-Centro de Pesquisas ( Site 1304)
Jaú, São Paulo, Brazil
A. C. Camargo Cancer Center ( Site 1318)
São Paulo, São Paulo, Brazil
Instituto Nacional de Câncer - INCA-Divisão de Pesquisa Clínica e Desenvolvimento Tecnológico HC1 ( Site 1319)
Rio de Janeiro, Brazil
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 1308)
São Paulo, Brazil
Hospital Paulistano-Americas Oncologia ( Site 1302)
São Paulo, Brazil
Specialized Hospital for Active Treatment of Haematology Diseases ( Site 6403)
Sofia, Sofia (stolitsa), Bulgaria
University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD ( Site 6404)
Plovdiv, Bulgaria
Medical Centre Pratia Clinic EOOD ( Site 6406)
Plovdiv, Bulgaria
UMHAT "Prof. Dr. Stoyan Kirkovich"AD-Clinical Hematology ( Site 6400)
Stara Zagora, Bulgaria
Multriprofile Hospital for Active Treatment "Hristo Botev" ( Site 6402)
Vratsa, Bulgaria
IC La Serena Research ( Site 1506)
La Serena, Coquimbo Region, 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
James Lind Centro de Investigacion del Cancer ( Site 1503)
Temuco, Región de la Araucanía, Chile
Biocenter ( Site 1507)
Concepción, Región del Biobío, Chile
Peking University Third Hospital ( Site 1602)
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital ( Site 1605)
Chongqing, Chongqing Municipality, China
Chongqing University Three Gorges Hospital ( Site 1609)
Chongqing, Chongqing Municipality, 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 Municipality, China
Shanxi Cancer Hospital ( Site 1629)
Taiyuan, Shanxi, China
Institute of hematology&blood disease hospital ( Site 1600)
Tianjin, Tianjin Municipality, China
Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 1604)
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University-Hematology ( Site 1611)
Hangzhou, Zhejiang, China
Clini Salud ( Site 1700)
Envigado, Antioquia, Colombia
Fundacion Colombiana de Cancerología Clinica Vida ( Site 1707)
Medellín, Antioquia, Colombia
Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1704)
Valledupar, Cesar Department, Colombia
Oncologos del Occidente ( Site 1706)
Pereira, Risaralda Department, Colombia
Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 1902)
Aarhus, Central Jutland, Denmark
Aalborg Universitetshospital, Syd ( Site 1901)
Aalborg, North Denmark, Denmark
Odense Universitetshospital ( Site 1900)
Odense C, Region Syddanmark, Denmark
Vejle Sygehus ( Site 1903)
Vejle, Region Syddanmark, Denmark
MEDI-K ( Site 2401)
Guatemala City, Guatemala
CELAN,S.A ( Site 2403)
Guatemala City, Guatemala
Oncomedica ( Site 2402)
Guatemala City, Guatemala
Queen Mary Hospital ( Site 2500)
Hksar, Hong Kong
Fejér Megyei Szent György Egyetemi Oktató Kórház ( Site 2609)
Székesfehérvár, Fejér, Hungary
Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet ( Site 2608)
Eger, Heves County, Hungary
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór-Haematológia osztály ( Site 2602)
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
Hospital of Lithuanian University of Health Sciences Kauno klinikos-Oncology and Hematology ( Site 3100)
Kaunas, Kaunas County, Lithuania
Hospital Sultanah Aminah ( Site 3203)
Johor Bahru, Johor, Malaysia
Hospital Ampang ( Site 3202)
Ampang, Selangor, Malaysia
Centro de Infusion Superare ( Site 3314)
Mexico City, Mexico City, Mexico
Health Pharma Professional Research S.A. de C.V: ( Site 3301)
Mexico City, Mexico City, Mexico
Centro de Investigacion Clinica Chapultepec ( Site 3309)
Morelia, Michoacán, Mexico
Oaxaca Site Management Organization ( Site 3313)
Oaxaca City, Mexico
Uniwersytecki Szpital Kliniczny nr 1 w Lublinie ( Site 3710)
Lublin, Lublin Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( Site 3701)
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 3702)
Gdansk, Pomeranian Voivodeship, Poland
Pratia Onkologia Katowice ( Site 3705)
Katowice, Silesian Voivodeship, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warmi-Oddzial Kliniczny Hematologii ( Site 3704)
Olsztyn, Warmian-Masurian Voivodeship, Poland
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S ( Site 3711)
Kielce, Świętokrzyskie Voivodeship, Poland
Spitalul Clinic Colțea ( Site 4000)
Bucharest, București, Romania
Spitalul Clinic Colțea ( Site 4001)
Bucharest, București, Romania
Institutul Oncologic Cluj ( Site 4002)
Cluj-Napoca, 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 City, 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 (Türkiye)
Namik Kemal University Medical Faculty-Hematology ( Site 4912)
Suleymanpasa, Tekirdas, Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 4913)
Ankara, Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 4906)
Istanbul, Turkey (Türkiye)
Ege Universitesi Hastanesi ( Site 4902)
Izmir, Turkey (Türkiye)
MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( Site 5106)
Cherkassy, Cherkasy Oblast, Ukraine
Communal non-profit enterprise "Regional clinical hospital o-Hematology Department ( Site 5113)
Ivano-Frankivsk, Ivano-Frankivsk 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 ( Site 5105)
Lviv, Lviv Oblast, Ukraine
SI National Research Center of Radiation Medicine, Hematology, Oncology ( Site 5101)
Kyiv, Ukraine
Public Non-Profit Enterprise Kyiv City Clinical Hospital #9 -Hematology department #1 ( Site 5111)
Kyiv, Ukraine