A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)
Start Date
12/13/2023
Completion Date
9/7/2032
Summary
The goal of this study is to evaluate nemtabrutinib compared with investigator's choice of ibrutinib or acalabrutinib in participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have not received any prior therapy. The primary hypotheses are that (1) nemtabrutinib is non-inferior to ibrutinib or acalabrutinib with respect to objective response rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 by blinded independent central review (BICR) and (2) nemtabrutinib is superior to ibrutinib or acalabrutinib with respect to progression free survival (PFS) per iwCLL Criteria 2018 by BICR.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Nemtabrutinib
Ibrutinib
Acalabrutinib
Conditions
Locations
USA Mitchell Cancer Institute ( Site 0014)
Mobile, Alabama 36604
United States
Banner MD Anderson Cancer Center ( Site 0059)
Gilbert, Arizona 85234
United States
Banner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0051)
Phoenix, Arizona 85006
United States
Arizona Oncology Associates - NAHOA ( Site 8007)
Prescott, Arizona 86301
United States
Alta Bates Summit Medical Center ( Site 0004)
Berkeley, California 94704
United States
Moores Cancer Center ( Site 0003)
La Jolla, California 92093-0698
United States
Care Access - South Pasadena ( Site 0070)
Pasadena, California 91105
United States
Saint Joseph Hospital ( Site 0026)
Denver, Colorado 80218
United States
Lutheran Medical Center ( Site 0027)
Golden, Colorado 80401
United States
Intermountain Health St. Mary's Regional Hospital ( Site 0025)
Grand Junction, Colorado 81501
United States
Eastern CT Hematology & Oncology Associates ( Site 0033)
Norwich, Connecticut 06360
United States
Lynn Cancer Center at Boca Raton Regional Hospital ( Site 0063)
Boca Raton, Florida 33486
United States
Clermont Oncology Center ( Site 0046)
Clermont, Florida 34711
United States
Florida Cancer Specialists - South ( Site 7001)
Fort Myers, Florida 33901
United States
Florida Cancer Specialists - East ( Site 7002)
West Palm Beach, Florida 33401
United States
Parkview Research Center at Parkview Regional Medical Center ( Site 0002)
Fort Wayne, Indiana 46845
United States
University of Iowa Health Care. ( Site 0017)
Iowa City, Iowa 52242
United States
University of Iowa Health Care. ( Site 0057)
Waukee, Iowa 50263
United States
Saint Elizabeth Healthcare ( Site 0041)
Edgewood, Kentucky 41017
United States
Owensboro Medical Health System ( Site 0066)
Owensboro, Kentucky 42303
United States
Corewell Health-Lemmon Holton Cancer Pavilion ( Site 0011)
Grand Rapids, Michigan 49503
United States
Regions Hospital ( Site 0042)
Saint Louis Park, Minnesota 55416
United States
MidAmerica Cancer Care, LLC ( Site 0043)
Kansas City, Missouri 64132
United States
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0052)
Billings, Montana 59102
United States
Summit Medical Group Cancer Center ( Site 0007)
Florham Park, New Jersey 07932
United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0016)
Hackensack, New Jersey 07601
United States
New York Oncology Hematology, P.C. ( Site 0069)
Albany, New York 12208
United States
Roswell Park Cancer Institute ( Site 0023)
Buffalo, New York 14263
United States
RPCI Oncology, PC- Northtowns ( Site 0061)
Williamsville, New York 14221
United States
Carolina Oncology Specialists, PA ( Site 0054)
Charlotte, North Carolina 28207
United States
Southeastern Medical Oncology Center ( Site 0049)
Goldsboro, North Carolina 27534
United States
Consultants in Medical Oncology and Hematology (CMOH) ( Site 8002)
Broomall, Pennsylvania 19008
United States
Cancer Care Associates Of York ( Site 0005)
York, Pennsylvania 17403
United States
Tennessee Oncology-Chattanooga ( Site 0045)
Chattanooga, Tennessee 37404
United States
Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 0031)
Nashville, Tennessee 37203
United States
Texas Oncology - Central/South Texas ( Site 8008)
Austin, Texas 78705
United States
The Center for Cancer and Blood Disorders ( Site 0032)
Fort Worth, Texas 76104
United States
Texas Oncology - San Antonio ( Site 8006)
San Antonio, Texas 78217
United States
Texas Oncology - Northeast Texas ( Site 8012)
Tyler, Texas 75702
United States
University of Virginia Cancer Center ( Site 0040)
Charlottesville, Virginia 22903
United States
Inova Schar Cancer Institute ( Site 0015)
Fairfax, Virginia 22031
United States
Virginia Commonwealth University (VCU) Medical Center ( Site 0030)
Richmond, Virginia 23298
United States
Medical Oncology Associates, PS (dba Summit Cancer Centers) ( Site 0010)
Spokane, Washington 99208
United States
SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical ( Site 0048)
Madison, Wisconsin 53715
United States
University Hospital and UW Health Clinics ( Site 0006)
Madison, Wisconsin 53792
United States
Royal North Shore Hospital ( Site 2806)
St Leonards, New South Wales 2065
Australia
AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0205)
Mechelen, Antwerpen 2800
Belgium
UZ Leuven-Hematology ( Site 0200)
Leuven, Vlaams-Brabant 3000
Belgium
Hospital 9 De Julho ( Site 2206)
São Paulo, São Paulo 01409-001
Brazil
Instituto Nacional de Câncer - INCA ( Site 2201)
Rio de Janeiro, 20230-130
Brazil
Hospital Paulistano-Americas Oncologia ( Site 2202)
São Paulo, 01321-001
Brazil
BC Cancer Kelowna ( Site 0112)
Kelowna, British Columbia V1Y 5L3
Canada
BC Cancer Victoria ( Site 0109)
Victoria, British Columbia V8R 6V5
Canada
William Osler Health System ( Site 0103)
Brampton, Ontario L6R 3J7
Canada
The Ottawa Hospital - General Campus ( Site 0102)
Ottawa, Ontario K1H 8L6
Canada
McGill University Health Centre ( Site 0106)
Montreal, Quebec H4A 3J1
Canada
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0100)
Rimouski, Quebec G5L 5T1
Canada
FALP-UIDO ( Site 2300)
Santiago, Region M. de Santiago 7500921
Chile
Clínica Alemana de Santiago-Unidad de Investigaciones ( Site 2306)
Santiago, Region M. de Santiago 7650568
Chile
Bradfordhill-Clinical Area ( Site 2310)
Santiago, Region M. de Santiago 8420383
Chile
Anhui Provincial Cancer Hospital ( Site 2001)
Hefei, Anhui 230031
China
Peking University First Hospital ( Site 2022)
Beijing, Beijing Municipality 100034
China
Peking University Third Hospital-Hematology ( Site 2011)
Beijing, Beijing Municipality 100191
China
Chongqing University Cancer Hospital ( Site 2041)
Chongqing, Chongqing Municipality 400030
China
Sun Yat-sen University Cancer Center ( Site 2028)
Guangzhou, Guangdong 510060
China
Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 2006)
Guangzhou, Guangdong 510515
China
Liuzhou People's Hospital ( Site 2029)
Liuzhou, Guangxi 545006
China
Guangxi Medical University Affiliated Tumor Hospital ( Site 2004)
Nanning, Guangxi 530200
China
The Affiliated Hospital of Guizhou Medical University ( Site 2024)
Guiyang, Guizhou 550004
China
Hainan General Hospital ( Site 2018)
Haikou, Hainan 570311
China
Henan Cancer Hospital-hematology department ( Site 2025)
Zhengzhou, Henan 450008
China
Tongji Hospital Affiliated to Tongji Medical College of HUST ( Site 2016)
Wuhan, Hubei 430000
China
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 2015)
Wuhan, Hubei 430058
China
Hunan Cancer Hospital ( Site 2020)
Changsha, Hunan 410006
China
The Second Xiangya Hospital of Central South University ( Site 2010)
Changsha, Hunan 410011
China
Jiangsu Province Hospital ( Site 2000)
Nanjing, Jiangsu 210029
China
The First Affliated Hospital of Suzhou University ( Site 2027)
Suzhou, Jiangsu 215000
China
The Affiliated Hospital of Xuzhou Medical College ( Site 2013)
Xuzhou, Jiangsu 221006
China
The First Affiliated Hospital of Nanchang University ( Site 2023)
Nanchang, Jiangxi 330006
China
Jiangxi Provincial Cancer Hospital ( Site 2009)
Nanchang, Jiangxi 330029
China
The First Hospital of Jilin University-Hematology ( Site 2030)
Changchun, Jilin 130021
China
Shaanxi provincial people's hospital ( Site 2012)
Xi'an, Shaanxi 710068
China
Shandong Cancer Hospital ( Site 2003)
Jinan, Shandong 250117
China
Shanxi Cancer Hospital ( Site 2033)
Taiyuan, Shanxi 030000
China
West China Hospital, Sichuan University-Head and Neck Oncology ( Site 2026)
Chengdu, Sichuan 610041
China
Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 2019)
Tianjin, Tianjin Municipality 300060
China
Institute of hematology&blood disease hospital-Lymphoma ( Site 2005)
Tianjin, Tianjin Municipality 301617
China
Xinjiang Medical University Cancer Hospital - Urumqi ( Site 2014)
Ürümqi, Xinjiang 830000
China
The first Affiliated Hospital, Zhejiang University School of Medicine-Hematology ( Site 2002)
Hangzhou, Zhejiang 310003
China
Zhejiang Cancer Hospital ( Site 2017)
Hangzhou, Zhejiang 310022
China
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 2405)
Valledupar, Cesar Department 200001
Colombia
IMAT S.A.S ( Site 2401)
Montería, Departamento de Córdoba 230002
Colombia
Fundacion Valle del Lili- CIC-Oncology CIC ( Site 2402)
Cali, Valle del Cauca Department 760032
Colombia
Fakultni nemocnice Hradec Kralove-IV. interni hematologicka klinika ( Site 0301)
Hradec Králové, 500 05
Czechia
Fakultni nemocnice Olomouc ( Site 0303)
Olomouc, 779 00
Czechia
Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0302)
Prague, 128 08
Czechia
Aalborg Universitetshospital, Syd ( Site 0403)
Aalborg, North Denmark 9000
Denmark
Roskilde Sygehus-Department of Hematology ( Site 0402)
Roskilde, Region Sjælland 4000
Denmark
Odense Universitetshospital-Department of Hematology ( Site 0401)
Odense C, Region Syddanmark 5000
Denmark
Universitaetsklinikum Ulm. ( Site 0601)
Ulm, Baden-Wurttemberg 89081
Germany
VK&K Studien GbR ( Site 0607)
Landshut, Bavaria 84036
Germany
Kliniken Maria Hilf ( Site 0603)
Mönchengladbach, North Rhine-Westphalia 41063
Germany
InVO Institut für Versorgungsforschung in der Onkologie ( Site 0606)
Koblenz, Rhineland-Palatinate 56068
Germany
Universitätsklinikum Halle ( Site 0604)
Halle, Saxony-Anhalt 06120
Germany
Onkologische Schwerpunktpraxis Kurfuerstendamm ( Site 0600)
Berlin, 10707
Germany
Evangelismos General Hospital of Athens ( Site 0700)
Athens, Attica 106 76
Greece
General Hospital of Athens "Laiko" ( Site 0704)
Athens, Attica 115 26
Greece
University Hospital of Alexandroupolis ( Site 0701)
Alexandroupoli, East Macedonia and Thrace 681 00
Greece
University Hospital of Ioannina ( Site 0702)
Ioannina, 455 00
Greece
Queen Mary Hospital ( Site 3300)
Hong Kong,
Hong Kong
Rambam Health Care Campus-Hematology and Bone Marrow Transplantation ( Site 1503)
Haifa, 3109601
Israel
Bnai Zion Medical Center ( Site 1505)
Haifa, 3339419
Israel
Hadassah Medical Center-Hemato-Oncology ( Site 1500)
Jerusalem, 9112001
Israel
Galilee Medical Center ( Site 1507)
Nahariya, 2201202
Israel
Rabin Medical Center ( Site 1504)
Petah Tikva, 4941492
Israel
Sheba Medical Center-Hemato Oncology ( Site 1501)
Ramat Gan, 5265601
Israel
Yitzhak Shamir Medical Center. ( Site 1506)
Ẕerifin, 7033001
Israel
Nagoya University Hospital ( Site 1907)
Nagoya, Aichi-ken 466-8560
Japan
Gunma University Hospital ( Site 1903)
Maebashi, Gunma 371-8511
Japan
Hokkaido University Hospital ( Site 1900)
Sapporo, Hokkaido 060-8648
Japan
Kobe City Medical Center General Hospital ( Site 1910)
Kobe, Hyōgo 650-0047
Japan
Tohoku University Hospital ( Site 1901)
Sendai, Miyagi 980-8574
Japan
Kindai University Hospital ( Site 1909)
Sakai, Osaka 590-0197
Japan
Shimane University Hospital ( Site 1911)
Izumo, Shimane 693-8501
Japan
Cancer Institute Hospital of JFCR ( Site 1906)
Koto, Tokyo 135-8550
Japan
Chiba Cancer Center ( Site 1905)
Chiba, 260-8717
Japan
Kyushu University Hospital ( Site 1914)
Fukuoka, 812-8582
Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital ( Site 1913)
Hiroshima, 730-8619
Japan
Okayama University Hospital ( Site 1912)
Okayama, 700-8558
Japan
Japanese Red Cross Osaka Hospital ( Site 1908)
Osaka, 543-8555
Japan
Yamagata University Hospital ( Site 1902)
Yamagata, 990-9585
Japan
University Malaya Medical Centre ( Site 1604)
Lembah Pantai, Kuala Lumpur 59100
Malaysia
Hospital Pulau Pinang ( Site 1602)
George Town, Pulau Pinang 10450
Malaysia
Queen Elizabeth Hospital ( Site 1603)
Kota Kinabalu, Sabah 88586
Malaysia
Centro de Infusion Superare ( Site 2602)
Mexico City, Mexico City 03100
Mexico
Health Pharma Professional Research S.A. de C.V: ( Site 2608)
Mexico City, Mexico City 03100
Mexico
Grupo Médico ASSET ( Site 2611)
Mexico City, 3100
Mexico
Waikato Hospital-Haematology ( Site 3202)
Hamilton, Waikato Region 3240
New Zealand
North Shore Hospital-Department of Haematology ( Site 3200)
Auckland, 0622
New Zealand
Aotearoa Clinical Trials ( Site 3201)
Auckland, 2025
New Zealand
Akershus Universitetssykehus ( Site 0902)
Lørenskog, Akershus 1474
Norway
Sykehuset i Vestfold ( Site 0903)
Tønsberg, Vestfold 3103
Norway
Oslo Universitetssykehus Rikshospitalet-Avdeling for blodsykdommer ( Site 0901)
Oslo, 0372
Norway
Centro Medico Monte Carmelo-Oncology ( Site 2706)
Arequipa, Ariqipa 054
Peru
Clínica Anglo Americana ( Site 2701)
Lima, 15073
Peru
Pratia MCM Krakow ( Site 1007)
Krakow, Lesser Poland Voivodeship 30-727
Poland
Uniwersytecki Szpital Kliniczny nr 1 w Lublinie-Oddział Hematoonkologii-Transplantacji Szpiku i Chem ( Site 1006)
Lublin, Lublin Voivodeship 20-081
Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site 1004)
Warsaw, Masovian Voivodeship 02-781
Poland
Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 1011)
Gdansk, Pomeranian Voivodeship 80-214
Poland
Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku-Oddział Hematologii i Transplantacji ( Site 1013)
Słupsk, Pomeranian Voivodeship 76-200
Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1000)
Gliwice, Silesian Voivodeship 44-102
Poland
Pratia Onkologia Katowice ( Site 1009)
Katowice, Silesian Voivodeship 40-519
Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA w Olsztynie-Oddzial Kliniczny Hematologii ( Site 1005)
Olsztyn, Warmian-Masurian Voivodeship 10-228
Poland
Instituto Português de Oncologia de Lisboa Francisco Gentil ( Site 3103)
Lisbon, Lisbon District 1099-023
Portugal
Champalimaud Foundation ( Site 3102)
Lisbon, Lisbon District 1400-038
Portugal
Unidade Local de Saude Gaia/Espinho - Hospital Eduardo Santos Silva ( Site 3107)
Vila Nova de Gaia, Porto District 4434-502
Portugal
Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 3104)
Lisbon, 1449-005
Portugal
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 3106)
Lisbon, 1649-035
Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 3100)
Porto, 4200-072
Portugal
Wits Clinical Research ( Site 1102)
Johannesburg, Gauteng 1864
South Africa
Netcare Pretoria East Hospital-Alberts Cellular Therapy ( Site 1101)
Pretoria, Gauteng 0181
South Africa
Groote Schuur Hospital-Clinical Haematology ( Site 1100)
Cape Town, Western Cape 7925
South Africa
Haemalife ( Site 1105)
Kuilsriver, Western Cape 7580
South Africa
Constantiaberg Haematology ( Site 1106)
Plumstead, Western Cape 7800
South Africa
Institut Català d'Oncologia - L'Hospitalet-Haematology Department ( Site 1207)
L'Hospitalet Del Llobregat, Barcelona 08908
Spain
HOSPITAL CLÍNIC DE BARCELONA ( Site 1202)
Barcelona, Catalonia 08036
Spain
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1209)
Pozuelo de Alarcón, Madrid 28223
Spain
HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 1208)
Majadahonda, Madrid, Comunidad de 28220
Spain
hospital universitario de canarias ( Site 1205)
San Cristóbal de La Laguna, Santa Cruz De Tenerife 38320
Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1206)
Barcelona, 08035
Spain
Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 1201)
Salamanca, 37007
Spain
Karolinska Universitetssjukhuset Solna ( Site 1302)
Stockholm, Stockholm County 171 64
Sweden
Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 1702)
Kaohsiung City, 833
Taiwan
National Cheng Kung University Hospital ( Site 1700)
Tainan, 704302
Taiwan
National Taiwan University Hospital ( Site 1701)
Taipei, 10048
Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 1703)
Taoyuan, 33305
Taiwan
Faculty of Medicine Siriraj Hospital-Division of Hematology, Department of Medicine ( Site 1801)
Bangkok, Bangkok 10700
Thailand
Chulalongkorn University ( Site 1802)
Pathumwan, Bangkok 10330
Thailand
Naresuan University Hospital ( Site 1804)
Muang, Changwat Phitsanulok 65000
Thailand
Songklanagarind hospital ( Site 1803)
Hat Yai, Changwat Songkhla 90110
Thailand
Maharaj Nakorn Chiang Mai Hospital ( Site 1800)
Muang, Chiang Mai 50200
Thailand
Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 1401)
Ankara, 06100
Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1407)
Ankara, 06800
Turkey (Türkiye)
Antalya Egitim ve Arastırma Hastanesi ( Site 1409)
Antalya, 7100
Turkey (Türkiye)
Trakya University Medical Faculty Hospital-Hematology ( Site 1403)
Edirne, 22030
Turkey (Türkiye)
Mega Medipol ( Site 1412)
Istanbul, 34214
Turkey (Türkiye)
Sisli Florence Nightingale Hastanesi ( Site 1411)
Istanbul, 34381
Turkey (Türkiye)
Marmara Universitesi Pendik Egitim Arastirma Hastanesi ( Site 1408)
Istanbul, 34899
Turkey (Türkiye)
Ege Universitesi Hastanesi ( Site 1404)
Izmir, 35100
Turkey (Türkiye)
Ondokuz Mays Üniversitesi ( Site 1410)
Samsun, 55280
Turkey (Türkiye)
Southmead Hospital ( Site 3010)
Bristol, Bristol, City of BS10 5NB
United Kingdom
Royal Lancaster Infirmary ( Site 3012)
Lancaster, Lancashire LA1 4RP
United Kingdom
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3006)
London, London, City of EC1A 7BE
United Kingdom
The Churchill Hospital ( Site 3007)
Oxford, Oxfordshire OX3 7LE
United Kingdom
GenesisCare - Bristol ( Site 3011)
Bristol, South Gloucestershire BS32 4SY
United Kingdom
GenesisCare - Cambridge ( Site 3001)
Newmarket, Suffolk CB8 7XN
United Kingdom
GenesisCare - Windsor ( Site 3002)
Windsor, Windsor And Maidenhead SL4 3HD
United Kingdom
Barnet Hospital ( Site 3005)
Barnet, EN5 3DJ
United Kingdom
St James's University Hospital ( Site 3004)
Leeds, LS9 7TF
United Kingdom
City Hospital, Nottingham University Hospitals NHS Trust ( Site 3003)
Nottingham, NG5 1PB
United Kingdom