RecruitingPhase 3NCT06136559

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)

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)

Sponsor

Merck Sharp & Dohme LLC

Enrollment

1,200 participants

Start Date

Dec 13, 2023

Study Type

INTERVENTIONAL

Conditions

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (BELLWAVE-011) compares a new BTK inhibitor drug called nemtabrutinib against standard BTK inhibitors (ibrutinib or acalabrutinib) as a first-line treatment for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) — slow-growing blood cancers that start in white blood cells. Nemtabrutinib may have a better safety profile than older BTK drugs. **You may be eligible if...** - You have confirmed CLL or SLL that needs treatment - You have never received systemic therapy for your CLL/SLL before - You are able to swallow pills - Your general health (ECOG score) is 0 to 2 **You may NOT be eligible if...** - You have already received systemic treatment for CLL/SLL - Your cancer has transformed to a more aggressive form (Richter Transformation) - You have significant cardiovascular disease - You have active hepatitis B or C - You have severe GI problems affecting how you absorb medication - You have a history of severe bleeding disorder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNemtabrutinib

Administered orally

DRUGIbrutinib

Administered orally

DRUGAcalabrutinib

Administered orally

Locations(196)

USA Mitchell Cancer Institute ( Site 0014)

Mobile, Alabama, United States

Banner MD Anderson Cancer Center ( Site 0059)

Gilbert, Arizona, United States

Banner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0051)

Phoenix, Arizona, United States

Arizona Oncology Associates - NAHOA ( Site 8007)

Prescott, Arizona, United States

Alta Bates Summit Medical Center ( Site 0004)

Berkeley, California, United States

Moores Cancer Center ( Site 0003)

La Jolla, California, United States

Care Access - South Pasadena ( Site 0070)

Pasadena, California, United States

Saint Joseph Hospital ( Site 0026)

Denver, Colorado, United States

Lutheran Medical Center ( Site 0027)

Golden, Colorado, United States

Intermountain Health St. Mary's Regional Hospital ( Site 0025)

Grand Junction, Colorado, United States

Eastern CT Hematology & Oncology Associates ( Site 0033)

Norwich, Connecticut, United States

Clermont Oncology Center ( Site 0046)

Clermont, Florida, United States

Florida Cancer Specialists - South ( Site 7001)

Fort Myers, Florida, United States

Florida Cancer Specialists - East ( Site 7002)

West Palm Beach, Florida, United States

Parkview Research Center at Parkview Regional Medical Center ( Site 0002)

Fort Wayne, Indiana, United States

University of Iowa Health Care. ( Site 0017)

Waukee, Iowa, United States

University of Iowa Health Care. ( Site 0057)

Waukee, Iowa, United States

Saint Elizabeth Healthcare ( Site 0041)

Edgewood, Kentucky, United States

Corewell Health-Lemmon Holton Cancer Pavilion ( Site 0011)

Grand Rapids, Michigan, United States

Regions Hospital ( Site 0042)

Saint Louis Park, Minnesota, United States

MidAmerica Cancer Care, LLC ( Site 0043)

Kansas City, Missouri, United States

Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0052)

Billings, Montana, United States

Summit Medical Group Cancer Center ( Site 0007)

Florham Park, New Jersey, United States

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0016)

Hackensack, New Jersey, United States

Roswell Park Cancer Institute ( Site 0023)

Buffalo, New York, United States

Carolina Oncology Specialists, PA ( Site 0054)

Charlotte, North Carolina, United States

Southeastern Medical Oncology Center ( Site 0049)

Goldsboro, North Carolina, United States

Consultants in Medical Oncology and Hematology (CMOH) ( Site 8002)

Broomall, Pennsylvania, United States

Cancer Care Associates Of York ( Site 0005)

York, Pennsylvania, United States

Tennessee Oncology-Chattanooga ( Site 0045)

Chattanooga, Tennessee, United States

Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 0031)

Nashville, Tennessee, United States

Texas Oncology - Central/South Texas ( Site 8008)

Austin, Texas, United States

The Center for Cancer and Blood Disorders ( Site 0032)

Fort Worth, Texas, United States

Texas Oncology - San Antonio ( Site 8006)

San Antonio, Texas, United States

Texas Oncology - Northeast Texas ( Site 8012)

Tyler, Texas, United States

University of Virginia Cancer Center ( Site 0040)

Charlottesville, Virginia, United States

Inova Schar Cancer Institute ( Site 0015)

Fairfax, Virginia, United States

Virginia Commonwealth University (VCU) Medical Center ( Site 0030)

Richmond, Virginia, United States

Medical Oncology Associates, PS (dba Summit Cancer Centers) ( Site 0010)

Spokane, Washington, United States

SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical ( Site 0048)

Madison, Wisconsin, United States

University Hospital and UW Health Clinics ( Site 0006)

Madison, Wisconsin, United States

Royal North Shore Hospital ( Site 2806)

St Leonards, New South Wales, Australia

AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0205)

Mechelen, Antwerpen, Belgium

UZ Leuven-Hematology ( Site 0200)

Leuven, Vlaams-Brabant, Belgium

Hospital 9 De Julho ( Site 2206)

São Paulo, São Paulo, Brazil

Instituto Nacional de Câncer - INCA ( Site 2201)

Rio de Janeiro, Brazil

Hospital Paulistano-Americas Oncologia ( Site 2202)

São Paulo, Brazil

BC Cancer Kelowna ( Site 0112)

Kelowna, British Columbia, Canada

BC Cancer Victoria ( Site 0109)

Victoria, British Columbia, Canada

William Osler Health System ( Site 0103)

Brampton, Ontario, Canada

The Ottawa Hospital - General Campus ( Site 0102)

Ottawa, Ontario, Canada

McGill University Health Centre ( Site 0106)

Montreal, Quebec, Canada

Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0100)

Rimouski, Quebec, Canada

FALP-UIDO ( Site 2300)

Santiago, Region M. de Santiago, Chile

Clínica Alemana de Santiago-Unidad de Investigaciones ( Site 2306)

Santiago, Region M. de Santiago, Chile

Bradfordhill-Clinical Area ( Site 2310)

Santiago, Region M. de Santiago, Chile

Anhui Provincial Cancer Hospital ( Site 2001)

Hefei, Anhui, China

Peking University First Hospital ( Site 2022)

Beijing, Beijing Municipality, China

Peking University Third Hospital-Hematology ( Site 2011)

Beijing, Beijing Municipality, China

Chongqing University Cancer Hospital ( Site 2041)

Chongqing, Chongqing Municipality, China

Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 2006)

Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center ( Site 2028)

Guangzhou, Guangdong, China

Liuzhou People's Hospital ( Site 2029)

Liuzhou, Guangxi, China

Guangxi Medical University Affiliated Tumor Hospital ( Site 2004)

Nanning, Guangxi, China

The Affiliated Hospital of Guizhou Medical University ( Site 2024)

Guiyang, Guizhou, China

Hainan General Hospital ( Site 2018)

Haikou, Hainan, China

Wuhan Union Hospital ( Site 2015)

Wuhan, Hebei, China

Henan Cancer Hospital-hematology department ( Site 2025)

Zhengzhou, Henan, China

Tongji Hospital Affiliated to Tongji Medical College of HUST ( Site 2016)

Wuhan, Hubei, China

Hunan Cancer Hospital ( Site 2020)

Changsha, Hunan, China

The Second Xiangya Hospital of Central South University ( Site 2010)

Changsha, Hunan, China

Jiangsu Province Hospital ( Site 2000)

Nanjing, Jiangsu, China

The First Affliated Hospital of Suzhou University ( Site 2027)

Suzhou, Jiangsu, China

The Affiliated Hospital of Xuzhou Medical College ( Site 2013)

Xuzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University ( Site 2023)

Nanchang, Jiangxi, China

Jiangxi Provincial Cancer Hospital ( Site 2009)

Nanchang, Jiangxi, China

The First Hospital of Jilin University-Hematology ( Site 2030)

Changchun, Jilin, China

Shaanxi provincial people's hospital ( Site 2012)

Xi'an, Shaanxi, China

Shandong Cancer Hospital ( Site 2003)

Jinan, Shandong, China

Shanxi Cancer Hospital ( Site 2033)

Taiyuan, Shanxi, China

West China Hospital, Sichuan University-Head and Neck Oncology ( Site 2026)

Chengdu, Sichuan, China

Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 2019)

Tianjin, Tianjin Municipality, China

Institute of hematology&blood disease hospital-Lymphoma ( Site 2005)

Tianjin, Tianjin Municipality, China

Xinjiang Medical University Cancer Hospital - Urumqi ( Site 2014)

Ürümqi, Xinjiang, China

The first Affiliated Hospital, Zhejiang University School of Medicine-Hematology ( Site 2002)

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital ( Site 2017)

Hangzhou, Zhejiang, China

Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 2405)

Valledupar, Cesar Department, Colombia

IMAT S.A.S ( Site 2401)

Montería, Departamento de Córdoba, Colombia

Fundacion Valle del Lili- CIC-Oncology CIC ( Site 2402)

Cali, Valle del Cauca Department, Colombia

Fakultni nemocnice Hradec Kralove-IV. interni hematologicka klinika ( Site 0301)

Hradec Králové, Czechia

Fakultni nemocnice Olomouc ( Site 0303)

Olomouc, Czechia

Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0302)

Prague, Czechia

Aalborg Universitetshospital, Syd ( Site 0403)

Aalborg, North Denmark, Denmark

Roskilde Sygehus-Department of Hematology ( Site 0402)

Roskilde, Region Sjælland, Denmark

Odense Universitetshospital-Department of Hematology ( Site 0401)

Odense C, Region Syddanmark, Denmark

Universitaetsklinikum Ulm. ( Site 0601)

Ulm, Baden-Wurttemberg, Germany

VK&K Studien GbR ( Site 0607)

Landshut, Bavaria, Germany

Kliniken Maria Hilf ( Site 0603)

Mönchengladbach, North Rhine-Westphalia, Germany

InVO Institut für Versorgungsforschung in der Onkologie ( Site 0606)

Koblenz, Rhineland-Palatinate, Germany

Universitätsklinikum Halle ( Site 0604)

Halle, Saxony-Anhalt, Germany

Onkologische Schwerpunktpraxis Kurfuerstendamm ( Site 0600)

Berlin, Germany

Evangelismos General Hospital of Athens ( Site 0700)

Athens, Attica, Greece

General Hospital of Athens "Laiko" ( Site 0704)

Athens, Attica, Greece

University Hospital of Alexandroupolis ( Site 0701)

Alexandroupoli, East Macedonia and Thrace, Greece

University Hospital of Ioannina ( Site 0702)

Ioannina, Greece

Queen Mary Hospital ( Site 3300)

Hong Kong, Hong Kong

Rambam Health Care Campus-Hematology and Bone Marrow Transplantation ( Site 1503)

Haifa, Israel

Bnai Zion Medical Center ( Site 1505)

Haifa, Israel

Hadassah Medical Center-Hemato-Oncology ( Site 1500)

Jerusalem, Israel

Galilee Medical Center ( Site 1507)

Nahariya, Israel

Rabin Medical Center ( Site 1504)

Petah Tikva, Israel

Sheba Medical Center-Hemato Oncology ( Site 1501)

Ramat Gan, Israel

Yitzhak Shamir Medical Center. ( Site 1506)

Ẕerifin, Israel

Nagoya University Hospital ( Site 1907)

Nagoya, Aichi-ken, Japan

Gunma University Hospital ( Site 1903)

Maebashi, Gunma, Japan

Hokkaido University Hospital ( Site 1900)

Sapporo, Hokkaido, Japan

Kobe City Medical Center General Hospital ( Site 1910)

Kobe, Hyōgo, Japan

Tohoku University Hospital ( Site 1901)

Sendai, Miyagi, Japan

Kindai University Hospital ( Site 1909)

Sakai, Osaka, Japan

Shimane University Hospital ( Site 1911)

Izumo, Shimane, Japan

Cancer Institute Hospital of JFCR ( Site 1906)

Koto, Tokyo, Japan

Chiba Cancer Center ( Site 1905)

Chiba, Japan

Kyushu University Hospital ( Site 1914)

Fukuoka, Japan

Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital ( Site 1913)

Hiroshima, Japan

Okayama University Hospital ( Site 1912)

Okayama, Japan

Japanese Red Cross Osaka Hospital ( Site 1908)

Osaka, Japan

Yamagata University Hospital ( Site 1902)

Yamagata, Japan

University Malaya Medical Centre ( Site 1604)

Lembah Pantai, Kuala Lumpur, Malaysia

Hospital Pulau Pinang ( Site 1602)

George Town, Pulau Pinang, Malaysia

Queen Elizabeth Hospital ( Site 1603)

Kota Kinabalu, Sabah, Malaysia

Centro de Infusion Superare ( Site 2602)

Mexico City, Mexico City, Mexico

Health Pharma Professional Research S.A. de C.V: ( Site 2608)

Mexico City, Mexico City, Mexico

Grupo Médico ASSET ( Site 2611)

Mexico City, Mexico

Waikato Hospital-Haematology ( Site 3202)

Hamilton, Waikato Region, New Zealand

North Shore Hospital-Department of Haematology ( Site 3200)

Auckland, New Zealand

Aotearoa Clinical Trials ( Site 3201)

Auckland, New Zealand

Akershus Universitetssykehus ( Site 0902)

Lørenskog, Akershus, Norway

Sykehuset i Vestfold ( Site 0903)

Tønsberg, Vestfold, Norway

Oslo Universitetssykehus Rikshospitalet-Avdeling for blodsykdommer ( Site 0901)

Oslo, Norway

Centro Medico Monte Carmelo-Oncology ( Site 2706)

Arequipa, Ariqipa, Peru

Clínica Anglo Americana ( Site 2701)

Lima, Peru

Pratia MCM Krakow ( Site 1007)

Krakow, Lesser Poland Voivodeship, Poland

Uniwersytecki Szpital Kliniczny nr 1 w Lublinie-Oddział Hematoonkologii-Transplantacji Szpiku i Chem ( Site 1006)

Lublin, Lublin Voivodeship, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site 1004)

Warsaw, Masovian Voivodeship, Poland

Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 1011)

Gdansk, Pomeranian Voivodeship, Poland

Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku-Oddział Hematologii i Transplantacji ( Site 1013)

Słupsk, Pomeranian Voivodeship, Poland

Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1000)

Gliwice, Silesian Voivodeship, Poland

Pratia Onkologia Katowice ( Site 1009)

Katowice, Silesian Voivodeship, Poland

Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA w Olsztynie-Oddzial Kliniczny Hematologii ( Site 1005)

Olsztyn, Warmian-Masurian Voivodeship, Poland

Instituto Português de Oncologia de Lisboa Francisco Gentil ( Site 3103)

Lisbon, Lisbon District, Portugal

Champalimaud Foundation ( Site 3102)

Lisbon, Lisbon District, Portugal

Unidade Local de Saude Gaia/Espinho - Hospital Eduardo Santos Silva ( Site 3107)

Vila Nova de Gaia, Porto District, Portugal

Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 3104)

Lisbon, Portugal

Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 3106)

Lisbon, Portugal

Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 3100)

Porto, Portugal

Wits Clinical Research ( Site 1102)

Johannesburg, Gauteng, South Africa

Netcare Pretoria East Hospital-Alberts Cellular Therapy ( Site 1101)

Pretoria, Gauteng, South Africa

Groote Schuur Hospital-Clinical Haematology ( Site 1100)

Cape Town, Western Cape, South Africa

Haemalife ( Site 1105)

Kuilsriver, Western Cape, South Africa

Constantiaberg Haematology ( Site 1106)

Plumstead, Western Cape, South Africa

Institut Català d'Oncologia - L'Hospitalet-Haematology Department ( Site 1207)

L'Hospitalet Del Llobregat, Barcelona, Spain

HOSPITAL CLÍNIC DE BARCELONA ( Site 1202)

Barcelona, Catalonia, Spain

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1209)

Pozuelo de Alarcón, Madrid, Spain

HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 1208)

Majadahonda, Madrid, Comunidad de, Spain

hospital universitario de canarias ( Site 1205)

San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain

Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1206)

Barcelona, Spain

Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 1201)

Salamanca, Spain

Karolinska Universitetssjukhuset Solna ( Site 1302)

Stockholm, Stockholm County, Sweden

Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 1702)

Kaohsiung City, Taiwan

National Cheng Kung University Hospital ( Site 1700)

Tainan, Taiwan

National Taiwan University Hospital ( Site 1701)

Taipei, Taiwan

Chang Gung Medical Foundation-Linkou Branch ( Site 1703)

Taoyuan, Taiwan

Faculty of Medicine Siriraj Hospital-Division of Hematology, Department of Medicine ( Site 1801)

Bangkok, Bangkok, Thailand

Chulalongkorn University ( Site 1802)

Pathumwan, Bangkok, Thailand

Naresuan University Hospital ( Site 1804)

Muang, Changwat Phitsanulok, Thailand

Songklanagarind hospital ( Site 1803)

Hat Yai, Changwat Songkhla, Thailand

Maharaj Nakorn Chiang Mai Hospital ( Site 1800)

Muang, Chiang Mai, Thailand

Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 1401)

Ankara, Turkey (Türkiye)

Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1407)

Ankara, Turkey (Türkiye)

Antalya Egitim ve Arastırma Hastanesi ( Site 1409)

Antalya, Turkey (Türkiye)

Trakya University Medical Faculty Hospital-Hematology ( Site 1403)

Edirne, Turkey (Türkiye)

Mega Medipol ( Site 1412)

Istanbul, Turkey (Türkiye)

Sisli Florence Nightingale Hastanesi ( Site 1411)

Istanbul, Turkey (Türkiye)

Marmara Universitesi Pendik Egitim Arastirma Hastanesi ( Site 1408)

Istanbul, Turkey (Türkiye)

Ege Universitesi Hastanesi ( Site 1404)

Izmir, Turkey (Türkiye)

Ondokuz Mays Üniversitesi ( Site 1410)

Samsun, Turkey (Türkiye)

Southmead Hospital ( Site 3010)

Bristol, Bristol, City of, United Kingdom

Royal Lancaster Infirmary ( Site 3012)

Lancaster, Lancashire, United Kingdom

St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3006)

London, London, City of, United Kingdom

The Churchill Hospital ( Site 3007)

Oxford, Oxfordshire, United Kingdom

GenesisCare - Bristol ( Site 3011)

Bristol, South Gloucestershire, United Kingdom

GenesisCare - Cambridge ( Site 3001)

Newmarket, Suffolk, United Kingdom

GenesisCare - Windsor ( Site 3002)

Windsor, Windsor And Maidenhead, United Kingdom

Barnet Hospital ( Site 3005)

Barnet, United Kingdom

St James's University Hospital ( Site 3004)

Leeds, United Kingdom

City Hospital, Nottingham University Hospitals NHS Trust ( Site 3003)

Nottingham, United Kingdom

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NCT06136559

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