NCT05624554Active, not recruitingPhase 3
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)
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
Source: ClinicalTrials.gov · Last updated 16 Mar 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 14 Nov 2022
- Start date
- 16 Mar 2023
- Primary completion date
- 19 May 2027
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Chronic lymphocytic leukaemia
- NCT number
- NCT05624554
- EU CT number
- 2022-501481-21-00
- EudraCT number
- 2021-006593-23
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 300
- From 16 Mar 2023 to the primary completion date, 19 May 2027
- 97 sites in 21 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has gastrointestinal dysfunction that may affect drug absorption (eg, gastric bypass surgery, gastrectomy)
- Has not adequately recovered from major surgery or has ongoing surgical complications
Other illness
- Has active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years, except basal cell carcinoma of skin, squamous cell carcinoma of skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potential curative therapy
- Has history of severe bleeding disorders
Who the study is looking for
- Confirmed diagnosis of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) and active disease clearly documented to have a need to initiate therapy
- 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
Criteria the registry did not label
- The main inclusion and exclusion criteria include but are not limited to the following:
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (97)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Adelaide Hospital ( Site 1105) Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD ( Site 6404) Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Unknown status |
| Medical Centre Pratia Clinic EOOD ( Site 6406) Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Unknown status |
| Specialized Hospital for Active Treatment of Haematology Diseases ( Site 6403) Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| UMHAT "Prof. Dr. Stoyan Kirkovich"AD-Clinical Hematology ( Site 6400) Coordinator of this site? Confirm its status | Stara Zagora | Bulgaria | Unknown status |
| Multriprofile Hospital for Active Treatment "Hristo Botev" ( Site 6402) Coordinator of this site? Confirm its status | Vratsa | Bulgaria | Unknown status |
| Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1317) Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Hospital Amaral Carvalho-Centro de Pesquisas ( Site 1304) Coordinator of this site? Confirm its status | Jaú | Brazil | Unknown status |
| Instituto Nacional de Câncer - INCA-Divisão de Pesquisa Clínica e Desenvolvimento Tecnológico HC1 ( Site 1319) Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| A. C. Camargo Cancer Center ( Site 1318) Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 1308) Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Hospital Paulistano-Americas Oncologia ( Site 1302) Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Biocenter ( Site 1507) Coordinator of this site? Confirm its status | Concepción | Chile | Unknown status |
| IC La Serena Research ( Site 1506) Coordinator of this site? Confirm its status | La Serena | Chile | Unknown status |
| FALP-UIDO ( Site 1500) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1509) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Clínica Inmunocel ( Site 1511) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| James Lind Centro de Investigacion del Cancer ( Site 1503) Coordinator of this site? Confirm its status | Temuco | Chile | Unknown status |
| Peking University Third Hospital ( Site 1602) Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Hospital of Jilin University-Hematology ( Site 1621) Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Xiangya Hospital Central South University-Hematology department ( Site 1616) Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Hunan Cancer Hospital ( Site 1615) Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Chongqing University Three Gorges Hospital ( Site 1609) Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Chongqing University Cancer Hospital ( Site 1605) Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 1607) Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Sun Yat-sen University Cancer Center ( Site 1608) Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The Affiliated Hospital of Guizhou Medical University ( Site 1625) Coordinator of this site? Confirm its status | Guiyang | China | Unknown status |
| Hainan General Hospital ( Site 1603) Coordinator of this site? Confirm its status | Haikou | China | Unknown status |
| The First Affiliated Hospital, Zhejiang University-Hematology ( Site 1611) Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The First Affiliated Hospital of Nanchang University ( Site 1614) Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Jiangxi Provincial Cancer Hospital ( Site 1628) Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Fudan University Shanghai Cancer Center ( Site 1606) Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The First Affiliated Hospital of Soochow University-hematology department ( Site 1612) Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Shanxi Cancer Hospital ( Site 1629) Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 1604) Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Institute of hematology&blood disease hospital ( Site 1600) Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1618) Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Tongji Hospital Tongji Medical,Science & Technology ( Site 1619) Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Shaanxi provincial people's hospital ( Site 1626) Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| The First Affiliated Hospital of Xi'an Jiaotong University ( Site 1617) Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Henan Cancer Hospital-hematology department ( Site 1613) Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Clini Salud ( Site 1700) Coordinator of this site? Confirm its status | Envigado | Colombia | Unknown status |
| Fundacion Colombiana de Cancerología Clinica Vida ( Site 1707) Coordinator of this site? Confirm its status | Medellín | Colombia | Unknown status |
| Oncologos del Occidente ( Site 1706) Coordinator of this site? Confirm its status | Pereira | Colombia | Unknown status |
| Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1704) Coordinator of this site? Confirm its status | Valledupar | Colombia | Unknown status |
| Aalborg Universitetshospital, Syd ( Site 1901) Coordinator of this site? Confirm its status | Aalborg | Denmark | Unknown status |
| Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 1902) Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
| Odense Universitetshospital ( Site 1900) Coordinator of this site? Confirm its status | Odense C | Denmark | Unknown status |
| Vejle Sygehus ( Site 1903) Coordinator of this site? Confirm its status | Vejle | Denmark | Unknown status |
| CELAN,S.A ( Site 2403) Coordinator of this site? Confirm its status | Guatemala City | Guatemala | Unknown status |
| MEDI-K ( Site 2401) Coordinator of this site? Confirm its status | Guatemala City | Guatemala | Unknown status |
| Oncomedica ( Site 2402) Coordinator of this site? Confirm its status | Guatemala City | Guatemala | Unknown status |
| Queen Mary Hospital ( Site 2500) Coordinator of this site? Confirm its status | Hksar | Hong Kong SAR China | Unknown status |
| Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet ( Site 2608) Coordinator of this site? Confirm its status | Eger | Hungary | Unknown status |
| Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór-Haematológia osztály ( Site 2602) Coordinator of this site? Confirm its status | Nyíregyháza | Hungary | Unknown status |
| Fejér Megyei Szent György Egyetemi Oktató Kórház ( Site 2609) Coordinator of this site? Confirm its status | Székesfehérvár | Hungary | Unknown status |
| Hospital of Lithuanian University of Health Sciences Kauno klinikos-Oncology and Hematology ( Site 3100) Coordinator of this site? Confirm its status | Kaunas | Lithuania | Unknown status |
| Centro de Infusion Superare ( Site 3314) Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Health Pharma Professional Research S.A. de C.V: ( Site 3301) Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Centro de Investigacion Clinica Chapultepec ( Site 3309) Coordinator of this site? Confirm its status | Morelia | Mexico | Unknown status |
| Oaxaca Site Management Organization ( Site 3313) Coordinator of this site? Confirm its status | Oaxaca City | Mexico | Unknown status |
| Hospital Ampang ( Site 3202) Coordinator of this site? Confirm its status | Ampang | Malaysia | Unknown status |
| Hospital Sultanah Aminah ( Site 3203) Coordinator of this site? Confirm its status | Johor Bahru | Malaysia | Unknown status |
| Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 3702) Coordinator of this site? Confirm its status | Gdansk | Poland | Unknown status |
| Pratia Onkologia Katowice ( Site 3705) Coordinator of this site? Confirm its status | Katowice | Poland | Unknown status |
| Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S ( Site 3711) Coordinator of this site? Confirm its status | Kielce | Poland | Unknown status |
| Uniwersytecki Szpital Kliniczny nr 1 w Lublinie ( Site 3710) Coordinator of this site? Confirm its status | Lublin | Poland | Unknown status |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warmi-Oddzial Kliniczny Hematologii ( Site 3704) Coordinator of this site? Confirm its status | Olsztyn | Poland | Unknown status |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( Site 3701) Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Spitalul Clinic Colțea ( Site 4001) Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
| Spitalul Clinic Colțea ( Site 4000) Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
| Institutul Oncologic Cluj ( Site 4002) Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Unknown status |
| National Cancer Centre Singapore ( Site 4200) Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Tan Tock Seng Hospital ( Site 4202) Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 4700) Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| National Cheng Kung University Hospital ( Site 4701) Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| National Taiwan University Hospital ( Site 4704) Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( Site 5106) Coordinator of this site? Confirm its status | Cherkassy | Ukraine | Unknown status |
| Communal non-profit enterprise "Regional clinical hospital o-Hematology Department ( Site 5113) Coordinator of this site? Confirm its status | Ivano-Frankivsk | Ukraine | Unknown status |
| Public Non-Profit Enterprise Kyiv City Clinical Hospital #9 -Hematology department #1 ( Site 5111) Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
| Nonprofit Organization National Cancer Institute ( Site 5103) Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
| SI National Research Center of Radiation Medicine, Hematology, Oncology ( Site 5101) Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
| Institute of Blood Pathology and Transfusion Medicine of National Aсademy of Medical Sciences of Ukr ( Site 5105) Coordinator of this site? Confirm its status | Lviv | Ukraine | Unknown status |
| Clermont Oncology Center ( Site 5224) Coordinator of this site? Confirm its status | Clermont | United States | Unknown status |
| Hattiesburg Clinic Hematology/Oncology ( Site 5216) Coordinator of this site? Confirm its status | Hattiesburg | United States | Unknown status |
| Medical Oncology Associates, PS ( Site 5206) Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| Highlands Oncology Group ( Site 5205) Coordinator of this site? Confirm its status | Springdale | United States | Unknown status |
| Groote Schuur Hospital-Clinical Haematology ( Site 4400) Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Netcare Pretoria East Hospital-Albert Alberts Stem Cell Transplant Centre ( Site 4401) Coordinator of this site? Confirm its status | Centurion | South Africa | Unknown status |
| Wits Clinical Research ( Site 4403) Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| Haemalife ( Site 4407) Coordinator of this site? Confirm its status | Kuilsriver | South Africa | Unknown status |
| Constantiaberg Haematology ( Site 4408) Coordinator of this site? Confirm its status | Plumstead | South Africa | Unknown status |
| Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 4913) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 4906) Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Ege Universitesi Hastanesi ( Site 4902) Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Unknown status |
| Mega Medipol-Hematology ( Site 4904) Coordinator of this site? Confirm its status | Stanbul | Turkey (Türkiye) | Unknown status |
| Namik Kemal University Medical Faculty-Hematology ( Site 4912) Coordinator of this site? Confirm its status | Suleymanpasa | Turkey (Türkiye) | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.