A Phase 3, Randomized Study to Compare Nemtabrutinib Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in Participants With Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BELLWAVE-011)
Status: Recruiting
Location: See all (184) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ The main inclusion criteria include but are not limited to the following:
• Confirmed diagnosis of CLL/SLL and active disease clearly documented to have a need to initiate therapy.
• Has at least 1 marker of disease burden.
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days before randomization.
• Has the ability to swallow and retain oral medication.
• Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV deoxyribonucleic acid (DNA) viral load before randomization.
• Participants with history of hepatitis C virus (HCV) infection are eligible if HCV ribonucleic acid (RNA) viral load is undetectable at screening.
• Participants with human immunodeficiency virus (HIV) who meet ALL eligibility criteria.
Locations
United States
Alabama
USA Mitchell Cancer Institute ( Site 0014)
RECRUITING
Mobile
Arizona
Arizona Oncology Associates - NAHOA ( Site 8007)
RECRUITING
Prescott
California
Alta Bates Summit Medical Center ( Site 0004)
RECRUITING
Berkeley
Moores Cancer Center ( Site 0003)
RECRUITING
La Jolla
Colorado
Saint Joseph Hospital ( Site 0026)
RECRUITING
Denver
Lutheran Medical Center ( Site 0027)
RECRUITING
Golden
Intermountain Health St. Mary's Regional Hospital ( Site 0025)
RECRUITING
Grand Junction
Connecticut
Eastern CT Hematology & Oncology Associates ( Site 0033)
RECRUITING
Norwich
Florida
Clermont Oncology Center ( Site 0046)
RECRUITING
Clermont
Florida Cancer Specialists - South ( Site 7001)
RECRUITING
Fort Myers
Florida Cancer Specialists - East ( Site 7002)
RECRUITING
West Palm Beach
Iowa
University of Iowa-Holden Comprehensive Cancer Center ( Site 0017)
RECRUITING
Iowa City
Indiana
Parkview Research Center at Parkview Regional Medical Center ( Site 0002)
RECRUITING
Fort Wayne
Kentucky
Saint Elizabeth Healthcare ( Site 0041)
RECRUITING
Edgewood
Michigan
Corewell Health-Lemmon Holton Cancer Pavilion ( Site 0011)
RECRUITING
Grand Rapids
Minnesota
Regions Hospital ( Site 0042)
RECRUITING
Saint Louis Park
Missouri
MidAmerica Cancer Care, LLC ( Site 0043)
RECRUITING
Kansas City
North Carolina
Oncology Specialists of Charlotte ( Site 0054)
RECRUITING
Charlotte
Southeastern Medical Oncology Center ( Site 0049)
RECRUITING
Goldsboro
New Jersey
Summit Medical Group Cancer Center ( Site 0007)
COMPLETED
Florham Park
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0016)
RECRUITING
Hackensack
New York
Roswell Park Cancer Institute ( Site 0023)
RECRUITING
Buffalo
Pennsylvania
Consultants in Medical Oncology and Hematology (CMOH) ( Site 8002)
RECRUITING
Broomall
Cancer Care Associates Of York ( Site 0005)
RECRUITING
York
Tennessee
Tennessee Oncology-Chattanooga ( Site 0045)
RECRUITING
Chattanooga
TENNESSEE ONCOLOGY ( Site 0031)
RECRUITING
Nashville
Texas
Texas Oncology - Central/South Texas ( Site 8008)
RECRUITING
Austin
The Center for Cancer and Blood Disorders ( Site 0032)
RECRUITING
Fort Worth
Texas Oncology - San Antonio ( Site 8006)
RECRUITING
San Antonio
Texas Oncology - Northeast Texas ( Site 8012)
RECRUITING
Tyler
Virginia
University of Virginia Cancer Center ( Site 0040)
RECRUITING
Charlottesville
Inova Schar Cancer Institute ( Site 0015)
RECRUITING
Fairfax
Virginia Commonwealth University (VCU) Medical Center ( Site 0030)
RECRUITING
Richmond
Washington
Medical Oncology Associates, PS (dba Summit Cancer Centers) ( Site 0010)
RECRUITING
Spokane
Wisconsin
University Hospital and UW Health Clinics ( Site 0006)
RECRUITING
Madison
Other Locations
Australia
Royal North Shore Hospital ( Site 2806)
COMPLETED
St Leonards
Belgium
UZ Leuven-Hematology ( Site 0200)
RECRUITING
Leuven
AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0205)
RECRUITING
Mechelen
Brazil
Instituto Nacional de Câncer - INCA ( Site 2201)
RECRUITING
Rio De Janeiro
Hospital 9 De Julho ( Site 2206)
RECRUITING
São Paulo
Hospital Paulistano-Americas Oncologia ( Site 2202)
RECRUITING
São Paulo
Canada
William Osler Health System ( Site 0103)
RECRUITING
Brampton
BC Cancer Kelowna ( Site 0112)
RECRUITING
Kelowna
McGill University Health Centre ( Site 0106)
RECRUITING
Montreal
The Ottawa Hospital - General Campus ( Site 0102)
RECRUITING
Ottawa
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0100)
COMPLETED
Rimouski
BC Cancer Victoria ( Site 0109)
RECRUITING
Victoria
Chile
Bradfordhill-Clinical Area ( Site 2310)
RECRUITING
Santiago
Clínica Alemana de Santiago-Unidad de Investigaciones ( Site 2306)
RECRUITING
Santiago
FALP-UIDO ( Site 2300)
RECRUITING
Santiago
China
Peking University First Hospital ( Site 2022)
RECRUITING
Beijing
Peking University Third Hospital-Hematology ( Site 2011)
RECRUITING
Beijing
The First Hospital of Jilin University-Hematology ( Site 2030)
RECRUITING
Changchun
Hunan Cancer Hospital ( Site 2020)
RECRUITING
Changsha
The Second Xiangya Hospital of Central South University ( Site 2010)
RECRUITING
Changsha
West China Hospital, Sichuan University-Head and Neck Oncology ( Site 2026)
RECRUITING
Chengdu
Chongqing University Cancer Hospital ( Site 2041)
RECRUITING
Chongqing
Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 2006)
RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center ( Site 2028)
RECRUITING
Guangzhou
The Affiliated Hospital of Guizhou Medical University ( Site 2024)
RECRUITING
Guiyang
Hainan General Hospital ( Site 2018)
RECRUITING
Haikou
The first Affiliated Hospital, Zhejiang University School of Medicine-Hematology ( Site 2002)
RECRUITING
Hangzhou
Zhejiang Cancer Hospital ( Site 2017)
RECRUITING
Hangzhou
Anhui Provincial Cancer Hospital ( Site 2001)
RECRUITING
Hefei
Shandong Cancer Hospital ( Site 2003)
RECRUITING
Jinan
Liuzhou People's Hospital ( Site 2029)
RECRUITING
Liuzhou
Jiangxi Provincial Cancer Hospital ( Site 2009)
RECRUITING
Nanchang
The First Affiliated Hospital of Nanchang University ( Site 2023)
RECRUITING
Nanchang
Jiangsu Province Hospital ( Site 2000)
RECRUITING
Nanjing
Guangxi Medical University Affiliated Tumor Hospital ( Site 2004)
RECRUITING
Nanning
The First Affliated Hospital of Suzhou University ( Site 2027)
RECRUITING
Suzhou
Shanxi Cancer Hospital ( Site 2033)
RECRUITING
Taiyuan
Institute of hematology&blood disease hospital-Lymphoma ( Site 2005)
RECRUITING
Tianjin
Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 2019)
RECRUITING
Tianjin
Xinjiang Medical University Cancer Hospital - Urumqi ( Site 2014)
RECRUITING
Ürümqi
Tongji Hospital Affiliated to Tongji Medical College of HUST ( Site 2016)
RECRUITING
Wuhan
Wuhan Union Hospital ( Site 2015)
RECRUITING
Wuhan
Shaanxi provincial people's hospital ( Site 2012)
RECRUITING
Xi'an
The Affiliated Hospital of Xuzhou Medical College ( Site 2013)
RECRUITING
Xuzhou
Henan Cancer Hospital-hematology department ( Site 2025)
RECRUITING
Zhengzhou
Colombia
IMAT S.A.S ( Site 2401)
RECRUITING
Montería
Fundacion Valle del Lili- CIC-Oncology CIC ( Site 2402)
RECRUITING
Santiago De Cali
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 2405)
RECRUITING
Valledupar
Denmark
Aalborg Universitetshospital, Syd ( Site 0403)
RECRUITING
Aalborg
Odense Universitetshospital-Department of Hematology ( Site 0401)
RECRUITING
Odense C
Roskilde Sygehus-Department of Hematology ( Site 0402)
RECRUITING
Roskilde
Germany
Onkologische Schwerpunktpraxis Kurfuerstendamm ( Site 0600)
RECRUITING
Berlin
Universitätsklinikum Halle ( Site 0604)
RECRUITING
Halle
InVO Institut für Versorgungsforschung in der Onkologie ( Site 0606)
RECRUITING
Koblenz
VK&K Studien GbR ( Site 0607)
RECRUITING
Landshut
Kliniken Maria Hilf ( Site 0603)
RECRUITING
Mönchengladbach
Universitaetsklinikum Ulm. ( Site 0601)
RECRUITING
Ulm
Greece
University Hospital of Alexandroupolis ( Site 0701)
RECRUITING
Alexandroupoli
Evangelismos General Hospital of Athens ( Site 0700)
RECRUITING
Athens
General Hospital of Athens Laiko ( Site 0704)
RECRUITING
Athens
University Hospital of Ioannina ( Site 0702)
RECRUITING
Ioannina
Hong Kong Special Administrative Region
Queen Mary Hospital ( Site 3300)
RECRUITING
Hong Kong
Israel
Bnai Zion Medical Center ( Site 1505)
RECRUITING
Haifa
Rambam Health Care Campus-Hematology and Bone Marrow Transplantation ( Site 1503)
RECRUITING
Haifa
Hadassah Medical Center-Hemato-Oncology ( Site 1500)
RECRUITING
Jerusalem
Galilee Medical Center ( Site 1507)
RECRUITING
Nahariya
Rabin Medical Center ( Site 1504)
RECRUITING
Petah Tikva
Sheba Medical Center-Hemato Oncology ( Site 1501)
RECRUITING
Ramat Gan
Yitzhak Shamir Medical Center. ( Site 1506)
RECRUITING
Ẕerifin
Japan
Chiba Cancer Center ( Site 1905)
ACTIVE_NOT_RECRUITING
Chiba
Kyushu University Hospital ( Site 1914)
RECRUITING
Fukuoka
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital ( Site 1913)
ACTIVE_NOT_RECRUITING
Hiroshima
Shimane University Hospital ( Site 1911)
ACTIVE_NOT_RECRUITING
Izumo
Kobe City Medical Center General Hospital ( Site 1910)
ACTIVE_NOT_RECRUITING
Kobe
Cancer Institute Hospital of JFCR ( Site 1906)
ACTIVE_NOT_RECRUITING
Koto
Gunma University Hospital ( Site 1903)
ACTIVE_NOT_RECRUITING
Maebashi
Nagoya University Hospital ( Site 1907)
ACTIVE_NOT_RECRUITING
Nagoya
Okayama University Hospital ( Site 1912)
ACTIVE_NOT_RECRUITING
Okayama
Japanese Red Cross Osaka Hospital ( Site 1908)
ACTIVE_NOT_RECRUITING
Osaka
Hokkaido University Hospital ( Site 1900)
ACTIVE_NOT_RECRUITING
Sapporo
Kindai University Hospital ( Site 1909)
ACTIVE_NOT_RECRUITING
Sayama
Tohoku University Hospital ( Site 1901)
ACTIVE_NOT_RECRUITING
Sendai
Yamagata University Hospital ( Site 1902)
ACTIVE_NOT_RECRUITING
Yamagata
Malaysia
Hospital Pulau Pinang ( Site 1602)
RECRUITING
George Town
Queen Elizabeth Hospital ( Site 1603)
RECRUITING
Kota Kinabalu
University Malaya Medical Centre ( Site 1604)
RECRUITING
Lembah Pantai
Mexico
Centro de Infusion Superare ( Site 2602)
RECRUITING
Mexico City
Health Pharma Professional Research S.A. de C.V: ( Site 2608)
RECRUITING
Mexico City
New Zealand
Aotearoa Clinical Trials ( Site 3201)
RECRUITING
Auckland
North Shore Hospital-Department of Haematology ( Site 3200)
RECRUITING
Auckland
Waikato Hospital-Haematology ( Site 3202)
RECRUITING
Hamilton
Norway
Akershus Universitetssykehus ( Site 0902)
RECRUITING
Lørenskog
Oslo Universitetssykehus Rikshospitalet-Avdeling for blodsykdommer ( Site 0901)
RECRUITING
Oslo
Sykehuset i Vestfold ( Site 0903)
RECRUITING
Tønsberg
Peru
Centro Medico Monte Carmelo-Oncology ( Site 2706)
RECRUITING
Arequipa
Clínica Anglo Americana ( Site 2701)
RECRUITING
Lima
Poland
Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 1011)
RECRUITING
Gdansk
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1000)
RECRUITING
Gliwice
Pratia Onkologia Katowice ( Site 1009)
RECRUITING
Katowice
Pratia MCM Krakow ( Site 1007)
RECRUITING
Krakow
Uniwersytecki Szpital Kliniczny nr 1 w Lublinie-Oddział Hematoonkologii-Transplantacji Szpiku i Chem ( Site 1006)
RECRUITING
Lublin
Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA w Olsztynie-Oddzial Kliniczny Hematologii ( Site 1005)
RECRUITING
Olsztyn
Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku-Oddział Hematologii i Transplantacji ( Site 1013)
RECRUITING
Słupsk
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site 1004)
RECRUITING
Warsaw
Portugal
Champalimaud Foundation ( Site 3102)
RECRUITING
Lisbon
Instituto Português de Oncologia de Lisboa Francisco Gentil ( Site 3103)
RECRUITING
Lisbon
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 3106)
RECRUITING
Lisbon
Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 3104)
RECRUITING
Lisbon
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 3100)
RECRUITING
Porto
Unidade Local de Saude Gaia/Espinho - Hospital Eduardo Santos Silva ( Site 3107)
RECRUITING
Vila Nova De Gaia
South Africa
Groote Schuur Hospital-Clinical Haematology ( Site 1100)
RECRUITING
Cape Town
Wits Clinical Research ( Site 1102)
RECRUITING
Johannesburg
Haemalife ( Site 1105)
RECRUITING
Kuilsriver
Constantiaberg Haematology ( Site 1106)
RECRUITING
Plumstead
Netcare Pretoria East Hospital-Alberts Cellular Therapy ( Site 1101)
RECRUITING
Pretoria
Spain
HOSPITAL CLÍNIC DE BARCELONA ( Site 1202)
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1206)
RECRUITING
Barcelona
Institut Català d'Oncologia - L'Hospitalet-Haematology Department ( Site 1207)
RECRUITING
L'hospitalet Del Llobregat
HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 1208)
RECRUITING
Majadahonda
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1209)
RECRUITING
Pozuelo De Alarcón
Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 1201)
RECRUITING
Salamanca
hospital universitario de canarias ( Site 1205)
RECRUITING
San Cristóbal De La Laguna
Sweden
Karolinska Universitetssjukhuset Solna ( Site 1302)
RECRUITING
Stockholm
Taiwan
Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 1702)
RECRUITING
Kaohsiung City
National Cheng Kung University Hospital ( Site 1700)
RECRUITING
Tainan City
National Taiwan University Hospital ( Site 1701)
RECRUITING
Taipei
Chang Gung Medical Foundation-Linkou Branch ( Site 1703)
RECRUITING
Taoyuan District
Thailand
Chulalongkorn University ( Site 1802)
RECRUITING
Bangkok
Faculty of Medicine Siriraj Hospital-Division of Hematology, Department of Medicine ( Site 1801)
RECRUITING
Bangkok
Songklanagarind hospital ( Site 1803)
RECRUITING
Hat Yai
Maharaj Nakorn Chiang Mai Hospital ( Site 1800)
RECRUITING
Muang
Naresuan University Hospital ( Site 1804)
RECRUITING
Muang
Turkey
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1407)
RECRUITING
Ankara
Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 1401)
RECRUITING
Ankara
Antalya Egitim ve Arastırma Hastanesi ( Site 1409)
RECRUITING
Antalya
Trakya University-Balkan Onkoloji Hastanesi ( Site 1403)
RECRUITING
Edirne
Marmara Universitesi Pendik Egitim Arastirma Hastanesi ( Site 1408)
RECRUITING
Istanbul
Ege Universitesi Hastanesi ( Site 1404)
RECRUITING
Izmir
Ondokuz Mays Üniversitesi ( Site 1410)
RECRUITING
Samsun
United Kingdom
Barnet Hospital ( Site 3005)
RECRUITING
Barnet
GenesisCare - Bristol ( Site 3011)
RECRUITING
Bristol
Southmead Hospital ( Site 3010)
COMPLETED
Bristol
Royal Lancaster Infirmary ( Site 3012)
RECRUITING
Lancaster
St James's University Hospital ( Site 3004)
RECRUITING
Leeds
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3006)
RECRUITING
London
GenesisCare - Cambridge ( Site 3001)
RECRUITING
Newmarket
City Hospital, Nottingham University Hospitals NHS Trust ( Site 3003)
RECRUITING
Nottingham
The Churchill Hospital ( Site 3007)
RECRUITING
Oxford
GenesisCare - Windsor ( Site 3002)
RECRUITING
Windsor
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2023-12-13
Estimated Completion Date: 2032-09-07
Participants
Target number of participants: 1200
Treatments
Experimental: Nemtabrutinib
Participants will receive nemtabrutinib at specified dose until disease progression, unacceptable toxicity or until discontinuation criteria are met.
Active_comparator: Ibrutinib/Acalabrutinib
Participants will receive investigator's choice of ibrutinib or acalabrutinib at specified dose until disease progression, unacceptable toxicity or until discontinuation criteria are met.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC