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)

Last updated: December 19, 2024
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Not Recruiting

Phase

3

Condition

Lymphoma

Leukemia (Pediatric)

Leukemia

Treatment

Ruxience

Fludarabine

Riabni

Clinical Study ID

NCT05624554
1026-008
2022-500164-35-00
2022-501481-21-00
2021-006593-23
MK-1026-008
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

  • Confirmed diagnosis of chronic lymphocytic leukemia (CLL)/ small lymphocyticlymphoma (SLL) and active disease clearly documented to have a need to initiatetherapy

  • Has previously untreated CLL/SLL participants without tumor protein 53 (TP53)aberrations and documented 11q status and immunoglobulin heavy chain gene (IGHV)mutational status

  • The ability to swallow and retain oral medication

Exclusion

Exclusion Criteria:

  • Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

  • Gastrointestinal dysfunction that may affect drug absorption (eg, gastric bypasssurgery, gastrectomy)

  • Known additional malignancy that is progressing or has required active treatmentwithin the past 3 years, except basal cell carcinoma of skin, squamous cellcarcinoma of skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer insitu) that have undergone potential curative therapy

  • History of severe bleeding disorders

  • Not adequately recovered from major surgery or has ongoing surgical complications

Study Design

Total Participants: 300
Treatment Group(s): 8
Primary Treatment: Ruxience
Phase: 3
Study Start date:
March 16, 2023
Estimated Completion Date:
March 17, 2031

Connect with a study center

  • Royal Adelaide Hospital ( Site 1105)

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1317)

    Curitiba, Parana 81520060
    Brazil

    Site Not Available

  • Hospital Amaral Carvalho-Centro de Pesquisas ( Site 1304)

    Jaú, Sao Paulo 17210-120
    Brazil

    Site Not Available

  • A. C. Camargo Cancer Center ( Site 1318)

    São Paulo, Sao Paulo 01509-010
    Brazil

    Site Not Available

  • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 1308)

    São Paulo, Sao Paulo 01246-000
    Brazil

    Active - Recruiting

  • Instituto Nacional de Câncer - INCA-Divisão de Pesquisa Clínica e Desenvolvimento Tecnológico HC1 (

    Rio de Janeiro, 20231-050
    Brazil

    Site Not Available

  • Hospital Paulistano-Americas Oncologia ( Site 1302)

    Sao Paulo, 01321-001
    Brazil

    Site Not Available

  • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 1308)

    Sao Paulo, 01246-000
    Brazil

    Site Not Available

  • Specialized Hospital for Active Treatment of Haematology Diseases ( Site 6403)

    Sofia, Sofia (stolitsa) 1797
    Bulgaria

    Site Not Available

  • Medical Centre Pratia Clinic EOOD ( Site 6406)

    Plovdiv, 4003
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD ( Site 6404)

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • UMHAT "Prof. Dr. Stoyan Kirkovich"AD-Clinical Hematology ( Site 6400)

    Stara Zagora, 6003
    Bulgaria

    Site Not Available

  • Multriprofile Hospital for Active Treatment "Hristo Botev" ( Site 6402)

    Vratsa, 3000
    Bulgaria

    Site Not Available

  • James Lind Centro de Investigacion del Cancer ( Site 1503)

    Temuco, Araucania 4800827
    Chile

    Site Not Available

  • James Lind Centro de Investigación del Cáncer ( Site 1503)

    Temuco, Araucania 4800827
    Chile

    Active - Recruiting

  • Biocenter ( Site 1507)

    Concepcion, Biobio 4070196
    Chile

    Site Not Available

  • Biocenter ( Site 1507)

    Concepción, Biobio 4070196
    Chile

    Site Not Available

  • IC La Serena Research ( Site 1506)

    La Serena, Coquimbo 1700000
    Chile

    Site Not Available

  • IC La Serena Research ( Site 1506)

    La Serena., Coquimbo 1720430
    Chile

    Site Not Available

  • Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1509)

    Santiago, Region M. De Santiago 7500653
    Chile

    Site Not Available

  • Clínica Inmunocel ( Site 1511)

    Santiago, Region M. De Santiago 7580206
    Chile

    Site Not Available

  • FALP-UIDO ( Site 1500)

    Santiago, Region M. De Santiago 7500921
    Chile

    Site Not Available

  • Peking University Third Hospital ( Site 1602)

    Beijing, Beijing 100191
    China

    Site Not Available

  • Chongqing University Cancer Hospital ( Site 1605)

    Chongqing, Chongqing 400030
    China

    Site Not Available

  • Chongqing University Three Gorges Hospital ( Site 1609)

    Chongqing, Chongqing 404199
    China

    Site Not Available

  • Chongqing Three Gorges Central Hospital ( Site 1609)

    Wanzhou, Chongqing 404199
    China

    Active - Recruiting

  • Chongqing University Three Gorges Hospital ( Site 1609)

    Wanzhou, Chongqing 404000
    China

    Site Not Available

  • Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 1607)

    Guangzhou, Guangdong 510515
    China

    Site Not Available

  • Sun Yat-sen University Cancer Center ( Site 1608)

    Guangzhou, Guangdong 510700
    China

    Site Not Available

  • The Affiliated Hospital of Guizhou Medical University ( Site 1625)

    Guiyang, Guizhou 550004
    China

    Site Not Available

  • Hainan General Hospital ( Site 1603)

    Haikou, Hainan 570311
    China

    Site Not Available

  • Henan Cancer Hospital-hematology department ( Site 1613)

    Zhengzhou, Henan 450008
    China

    Site Not Available

  • Tongji Hospital Tongji Medical,Science & Technology ( Site 1619)

    Wuhan, Hubei 430000
    China

    Site Not Available

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1618)

    Wuhan, Hubei 430010
    China

    Site Not Available

  • Hunan Cancer Hospital ( Site 1615)

    Changsha, Hunan 410013
    China

    Site Not Available

  • Xiangya Hospital Central South University-Hematology department ( Site 1616)

    Changsha, Hunan 410008
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University-hematology department ( Site 1612)

    Suzhou, Jiangsu 215006
    China

    Site Not Available

  • Jiangxi Provincial Cancer Hospital ( Site 1628)

    Nanchang, Jiangxi 330029
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University ( Site 1614)

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • The First Hospital of Jilin University-Hematology ( Site 1621)

    Changchun, Jilin 130021
    China

    Site Not Available

  • Shaanxi provincial people's hospital ( Site 1626)

    Xi'an, Shaanxi 710068
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Jiaotong University ( Site 1617)

    Xi'an, Shaanxi 710061
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center ( Site 1606)

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • Shanxi Cancer Hospital ( Site 1629)

    Taiyuan, Shanxi 030013
    China

    Site Not Available

  • Institute of hematology&blood disease hospital ( Site 1600)

    Tianjin, Tianjin 300020
    China

    Site Not Available

  • Institute of hematology&blood disease hospital-Hematology ( Site 1600)

    Tianjin, Tianjin 301636
    China

    Active - Recruiting

  • Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 1604)

    Tianjin, Tianjin 300060
    China

    Site Not Available

  • The First Affiliated Hospital, Zhejiang University-Hematology ( Site 1611)

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

  • Clini Salud ( Site 1700)

    Envigado, Antioquia 055422
    Colombia

    Site Not Available

  • Fundacion Colombiana de Cancerología Clinica Vida ( Site 1707)

    Medellin, Antioquia 050030
    Colombia

    Site Not Available

  • Fundación Colombiana de Cancerología Clínica Vida ( Site 1707)

    Medellin, Antioquia 050030
    Colombia

    Active - Recruiting

  • Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1704)

    Valledupar, Cesar 200001
    Colombia

    Site Not Available

  • Oncologos del Occidente ( Site 1706)

    Pereira, Risaralda 660001
    Colombia

    Site Not Available

  • Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 1902)

    Aarhus, Midtjylland 8200
    Denmark

    Site Not Available

  • Aalborg Universitetshospital, Syd ( Site 1901)

    Aalborg, Nordjylland 9000
    Denmark

    Site Not Available

  • Odense Universitetshospital ( Site 1900)

    Odense, Syddanmark 5000
    Denmark

    Site Not Available

  • Odense Universitetshospital ( Site 1900)

    Odense C, Syddanmark 5000
    Denmark

    Site Not Available

  • Vejle Sygehus ( Site 1903)

    Vejle, Syddanmark 7100
    Denmark

    Site Not Available

  • CELAN,S.A ( Site 2403)

    Guatemala, 01010
    Guatemala

    Site Not Available

  • MEDI-K ( Site 2401)

    Guatemala, 01009
    Guatemala

    Site Not Available

  • MEDI-K CAYALA ( Site 2401)

    Guatemala, 01016
    Guatemala

    Active - Recruiting

  • Oncomedica-Guatemala ( Site 2402)

    Guatemala, 01010
    Guatemala

    Site Not Available

  • Queen Mary Hospital ( Site 2500)

    Hksar,
    Hong Kong

    Site Not Available

  • Prince of Wales Hospital-Department of Medicine & Therapeutics (Haematology) ( Site 2501)

    Shatin, NT
    Hong Kong

    Site Not Available

  • Fejér Megyei Szent György Egyetemi Oktató Kórház ( Site 2609)

    Székesfehérvár, Fejer 8000
    Hungary

    Site Not Available

  • Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet ( Site 2608)

    Eger, Heves 3300
    Hungary

    Site Not Available

  • Markhot Ferenc Oktatokorhaz es Rendelointezet ( Site 2608)

    Eger, Heves 3300
    Hungary

    Active - Recruiting

  • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór-Haematológia osztály ( Site 2602)

    Nyiregyhaza, Szabolcs-Szatmar-Bereg 4400
    Hungary

    Site Not Available

  • Hospital of Lithuanian University of Health Sciences Kauno klinikos-Oncology and Hematology ( Site 3

    Kaunas, Kauno Apskritis 50161
    Lithuania

    Site Not Available

  • Hospital Sultanah Aminah ( Site 3203)

    Johor Bahru, Johor 80100
    Malaysia

    Site Not Available

  • Hospital Ampang ( Site 3202)

    Ampang, Selangor 68000
    Malaysia

    Site Not Available

  • Centro de Infusion Superare ( Site 3314)

    Ciudad de México, Distrito Federal 03100
    Mexico

    Site Not Available

  • Health Pharma Professional Research S.A. de C.V: ( Site 3301)

    Ciudad de México, Distrito Federal 03100
    Mexico

    Site Not Available

  • Centro de Investigacion Clinica Chapultepec ( Site 3309)

    Morelia, Michoacan 58260
    Mexico

    Site Not Available

  • Oaxaca Site Management Organization ( Site 3313)

    Oaxaca, 68000
    Mexico

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny nr 1-Department of Haematooncology and Bone Marrow Transpla

    Lublin, Lubelskie 20-081
    Poland

    Site Not Available

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( S

    Warszawa, Mazowieckie 02-781
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 3702)

    Gdansk, Pomorskie 80-952
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 3702)

    Gdańsk, Pomorskie 80-211
    Poland

    Site Not Available

  • Pratia Onkologia Katowice ( Site 3705)

    Katowice, Slaskie 40-519
    Poland

    Site Not Available

  • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S

    Kielce, Swietokrzyskie 25-734
    Poland

    Site Not Available

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warmi-Oddzial Kliniczny Hematologii ( Site 37

    Olsztyn, Warminsko-mazurskie 10-228
    Poland

    Site Not Available

  • Spitalul Clinic Colțea ( Site 4000)

    București, Bucuresti 030171
    Romania

    Site Not Available

  • Spitalul Clinic Colțea ( Site 4001)

    București, Bucuresti 030171
    Romania

    Site Not Available

  • Institutul Oncologic Cluj ( Site 4002)

    Cluj, 400015
    Romania

    Site Not Available

  • National Cancer Centre Singapore ( Site 4200)

    Singapore, Central Singapore 168583
    Singapore

    Site Not Available

  • Tan Tock Seng Hospital ( Site 4202)

    Singapore, Central Singapore 308433
    Singapore

    Site Not Available

  • Netcare Pretoria East Hospital-Albert Alberts Stem Cell Transplant Centre ( Site 4401)

    Centurion, Gauteng 0181
    South Africa

    Site Not Available

  • Wits Clinical Research ( Site 4403)

    Johannesburg, Gauteng 1864
    South Africa

    Site Not Available

  • Groote Schuur Hospital-Clinical Haematology ( Site 4400)

    Cape Town, Western Cape 7925
    South Africa

    Site Not Available

  • Haemalife ( Site 4407)

    Kuilsriver, Western Cape 7580
    South Africa

    Site Not Available

  • Constantiaberg Haematology ( Site 4408)

    Plumstead, Western Cape 7800
    South Africa

    Site Not Available

  • Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 4700)

    Kaohsiung, 83301
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital ( Site 4701)

    Tainan, 704
    Taiwan

    Site Not Available

  • National Taiwan University Hospital ( Site 4704)

    Taipei, 10002
    Taiwan

    Site Not Available

  • Mega Medipol-Hematology ( Site 4904)

    Stanbul, Istanbul 34214
    Turkey

    Site Not Available

  • Namik Kemal University Medical Faculty-Hematology ( Site 4912)

    Suleymanpasa, Tekirdas 59100
    Turkey

    Site Not Available

  • Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 4913)

    Ankara, 06100
    Turkey

    Site Not Available

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 4906)

    Istanbul, 34722
    Turkey

    Site Not Available

  • Ege Universitesi Hastanesi ( Site 4902)

    İzmir, 35100
    Turkey

    Site Not Available

  • MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( S

    Cherkassy, Cherkaska Oblast 18009
    Ukraine

    Site Not Available

  • Communal non-profit enterprise "Regional clinical hospital o-Hematology Department ( Site 5113)

    Ivano-Frankivsk, Ivano-Frankivska Oblast 76008
    Ukraine

    Site Not Available

  • Nonprofit Organization National Cancer Institute ( Site 5103)

    Kyiv, Kyivska Oblast 03022
    Ukraine

    Site Not Available

  • Institute of Blood Pathology and Transfusion Medicine of National Aсademy of Medical Sciences of Ukr

    Lviv, Lvivska Oblast 79057
    Ukraine

    Site Not Available

  • National Research Center for Radiation Medicine of National Academy of Medical Sciences of Ukraine (

    Kyiv, 03115
    Ukraine

    Site Not Available

  • Public Non-Profit Enterprise Kyiv City Clinical Hospital #9 -Hematology department #1 ( Site 5111)

    Kyiv, 04112
    Ukraine

    Site Not Available

  • Highlands Oncology Group ( Site 5205)

    Springdale, Arkansas 72762
    United States

    Site Not Available

  • Clermont Oncology Center ( Site 5224)

    Clermont, Florida 34711
    United States

    Site Not Available

  • Hattiesburg Clinic Hematology/Oncology ( Site 5216)

    Hattiesburg, Mississippi 39401
    United States

    Site Not Available

  • Medical Oncology Associates, PS ( Site 5206)

    Spokane, Washington 99208
    United States

    Site Not Available

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