Chronic Lymphocytic LeukemiaPhase 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 study testing Nemtabrutinib, Ibrutinib and Acalabrutinib in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Merck Sharp & Dohme LLC at 206 sites in 29 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- What is being tested?
- Nemtabrutinib, Ibrutinib and Acalabrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 206 sitesin 29 countries
- Study dates
- 13 Dec 2023to 7 Sep 2032
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection.
- Has gastrointestinal (GI) dysfunction that may affect drug absorption.
- Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL/SLL.
- Has had acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in the past 12 months before screening.
- Has clinically significant cardiovascular disease.
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- Has hypersensitivity to nemtabrutinib or contraindication to ibrutinib or acalabrutinib, or any of the excipients.
- Has history of severe bleeding disorder.
- Has known additional malignancy that is progressing or has required active treatment within the past 2 years.
- Has received any systemic anticancer therapy for CLL/SLL.
- Is currently being treated with p-glycoprotein (P-gp) substrates with a narrow therapeutic index, cytochrome P450 3A (CYP3A) strong or moderate inducers or CYP3A strong inhibitors.
- Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
- Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration.
- Has active infection requiring systemic therapy, including intravenous (IV) antibiotics during screening.
- Participants who have not adequately recovered from major surgery or have ongoing surgical complications.
Trial locations and contacts
206 sites in 29 countries. Contact the study team or a site near you to ask about taking part.
206 sites in 29 countries
United States49 sites, 46 recruiting
- Recruiting
New York Oncology Hematology, P.C. ( Site 0069)
Albany, New York, 12208
Study Coordinator, 518-262-6696
- Recruiting
Texas Oncology - Central/South Texas ( Site 8008)
Austin, Texas, 78705
Study Coordinator, 512-421-4100
- Active, not recruiting
Alta Bates Summit Medical Center ( Site 0004)
Berkeley, California, 94704
- Recruiting
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0052)
Billings, Montana, 59102
Study Coordinator, 406-238-6685
- Recruiting
Lynn Cancer Center at Boca Raton Regional Hospital ( Site 0063)
Boca Raton, Florida, 33486
Study Coordinator, 561-955-4800
- Recruiting
Saint Alphonsus Regional Medical Center ( Site 0067)
Boise, Idaho, 83706
Study Coordinator, 208-367-3131
- Recruiting
Consultants in Medical Oncology and Hematology (CMOH) ( Site 8002)
Broomall, Pennsylvania, 19008
Study Coordinator, 610-585-6287
- Recruiting
Roswell Park Cancer Institute ( Site 0023)
Buffalo, New York, 14263
Study Coordinator, 716-845-2300
- Recruiting
Carolina Oncology Specialists, PA ( Site 0054)
Charlotte, North Carolina, 28207
Study Coordinator, 704-342-1900
- Recruiting
University of Virginia Cancer Center ( Site 0040)
Charlottesville, Virginia, 22903
Study Coordinator, 434-243-2649
- Recruiting
Tennessee Oncology-Chattanooga ( Site 0045)
Chattanooga, Tennessee, 37404
Study Coordinator, 615-986-4350
- Recruiting
Clermont Oncology Center ( Site 0046)
Clermont, Florida, 34711
Study Coordinator, 386-538-3169
- Recruiting
Saint Joseph Hospital ( Site 0026)
Denver, Colorado, 80218
Study Coordinator, 303-403-6381
- Recruiting
Saint Elizabeth Healthcare ( Site 0041)
Edgewood, Kentucky, 41017
Study Coordinator, 859-301-2000
- Recruiting
Swedish Cancer Institute, Edmonds Campus ( Site 0072)
Edmonds, Washington, 98026
Study Coordinator, 206-215-3100
- Recruiting
Inova Schar Cancer Institute ( Site 0015)
Fairfax, Virginia, 22031
Study Coordinator, 571-472-4724
- Completed
Summit Medical Group Cancer Center ( Site 0007)
Florham Park, New Jersey, 07932
- Recruiting
Florida Cancer Specialists - South ( Site 7001)
Fort Myers, Florida, 33901
Study Coordinator, 239-274-9930
- Recruiting
Parkview Research Center at Parkview Regional Medical Center ( Site 0002)
Fort Wayne, Indiana, 46845
Study Coordinator, 260-266-7100
- Recruiting
The Center for Cancer and Blood Disorders ( Site 0032)
Fort Worth, Texas, 76104
Study Coordinator, 817-759-7013
- Recruiting
Banner MD Anderson Cancer Center ( Site 0059)
Gilbert, Arizona, 85234
Study Coordinator, 480-256-5490
- Recruiting
Lutheran Medical Center ( Site 0027)
Golden, Colorado, 80401
Study Coordinator, 303-403-6381
- Recruiting
Southeastern Medical Oncology Center ( Site 0049)
Goldsboro, North Carolina, 27534
Study Coordinator, 919-587-9088
- Recruiting
Intermountain Health St. Mary's Regional Hospital ( Site 0025)
Grand Junction, Colorado, 81501
Study Coordinator, 970-298-7638
- Recruiting
Corewell Health-Lemmon Holton Cancer Pavilion ( Site 0011)
Grand Rapids, Michigan, 49503
Study Coordinator, 616-267-7566
- Recruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0016)
Hackensack, New Jersey, 07601
Study Coordinator, 551-996-3277
- Recruiting
University of Iowa Health Care. ( Site 0017)
Iowa City, Iowa, 52242
Study Coordinator, 319-356-1616
- Recruiting
Swedish Cancer Institute, Issaquah Campus ( Site 0073)
Issaquah, Washington, 98029
Study Coordinator, 206-215-3100
- Recruiting
MidAmerica Cancer Care, LLC ( Site 0043)
Kansas City, Missouri, 64132
Study Coordinator, 816-974-5050
- Recruiting
Moores Cancer Center ( Site 0003)
La Jolla, California, 92093-0698
Study Coordinator, 858-534-5201
- Recruiting
SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical ( Site 0048)
Madison, Wisconsin, 53715
Study Coordinator, 608-410-2700
- Recruiting
University Hospital and UW Health Clinics ( Site 0006)
Madison, Wisconsin, 53792
Study Coordinator, 608-263-6400
- Recruiting
USA Mitchell Cancer Institute ( Site 0014)
Mobile, Alabama, 36604
Study Coordinator, 251-665-8000
- Recruiting
Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 0031)
Nashville, Tennessee, 37203
Study Coordinator, 615-986-4350
- Recruiting
Eastern CT Hematology & Oncology Associates ( Site 0033)
Norwich, Connecticut, 06360
Study Coordinator, 860-886-8362
- Recruiting
Owensboro Medical Health System ( Site 0066)
Owensboro, Kentucky, 42303
Study Coordinator, 270-688-1938
- Recruiting
Care Access - South Pasadena ( Site 0070)
Pasadena, California, 91105
Study Coordinator, 626-556-9930
- Recruiting
Banner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0051)
Phoenix, Arizona, 85006
Study Coordinator, 480-256-5490
- Completed
Arizona Oncology Associates - NAHOA ( Site 8007)
Prescott, Arizona, 86301
- Recruiting
Virginia Commonwealth University (VCU) Medical Center ( Site 0030)
Richmond, Virginia, 23298
Study Coordinator, 804-628-2072
- Recruiting
Regions Hospital ( Site 0042)
Saint Louis Park, Minnesota, 55416
Study Coordinator, 952-993-3252
- Recruiting
Texas Oncology - San Antonio ( Site 8006)
San Antonio, Texas, 78217
Study Coordinator, 210-419-2608
- Recruiting
Swedish Medical Center-Swedish Cancer Institute ( Site 0071)
Seattle, Washington, 98104
Study Coordinator, 206-215-3100
- Recruiting
Medical Oncology Associates, PS (dba Summit Cancer Centers) ( Site 0010)
Spokane, Washington, 99208
Study Coordinator, 509-462-2273
- Recruiting
Texas Oncology - Northeast Texas ( Site 8012)
Tyler, Texas, 75702
Study Coordinator, 903-579-9800
- Recruiting
University of Iowa Health Care. ( Site 0057)
Waukee, Iowa, 50263
Study Coordinator, 319-356-1616
- Recruiting
Florida Cancer Specialists - East ( Site 7002)
West Palm Beach, Florida, 33401
Study Coordinator, 727-216-1143
- Recruiting
RPCI Oncology, PC- Northtowns ( Site 0061)
Williamsville, New York, 14221
Study Coordinator, 716-634-3340
- Recruiting
Cancer Care Associates Of York ( Site 0005)
York, Pennsylvania, 17403
Study Coordinator, 717-741-9229
China30 sites, 30 recruiting
- Recruiting
Peking University First Hospital ( Site 2022)
Beijing, Beijing Municipality, 100034
Study Coordinator, 010-83575680
- Recruiting
Peking University Third Hospital-Hematology ( Site 2011)
Beijing, Beijing Municipality, 100191
Study Coordinator, 010-82264404
- Recruiting
The First Hospital of Jilin University-Hematology ( Site 2030)
Changchun, Jilin, 130021
Study Coordinator, 0431-81879901
- Recruiting
Hunan Cancer Hospital ( Site 2020)
Changsha, Hunan, 410006
Study Coordinator, 0731-89762281
- Recruiting
The Second Xiangya Hospital of Central South University ( Site 2010)
Changsha, Hunan, 410011
Study Coordinator, +86 073185292097
- Recruiting
West China Hospital, Sichuan University-Head and Neck Oncology ( Site 2026)
Chengdu, Sichuan, 610041
Study Coordinator, 02885423278
- Recruiting
Chongqing University Cancer Hospital ( Site 2041)
Chongqing, Chongqing Municipality, 400030
Study Coordinator, 02365079270
- Recruiting
Sun Yat-sen University Cancer Center ( Site 2028)
Guangzhou, Guangdong, 510060
Study Coordinator, 020-87343886
- Recruiting
Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 2006)
Guangzhou, Guangdong, 510515
Study Coordinator, +86 02062786845
- Recruiting
The Affiliated Hospital of Guizhou Medical University ( Site 2024)
Guiyang, Guizhou, 550004
Study Coordinator, 0851-86740793
- Recruiting
Hainan General Hospital ( Site 2018)
Haikou, Hainan, 570311
Study Coordinator, (0898)68622479
- Recruiting
The first Affiliated Hospital, Zhejiang University School of Medicine-Hematology ( Site 2002)
Hangzhou, Zhejiang, 310003
Study Coordinator, 057187236114
- Recruiting
Zhejiang Cancer Hospital ( Site 2017)
Hangzhou, Zhejiang, 310022
Study Coordinator, 0571-88122198
- Recruiting
Anhui Provincial Cancer Hospital ( Site 2001)
Hefei, Anhui, 230031
Study Coordinator, 0551-65329163
- Recruiting
Shandong Cancer Hospital ( Site 2003)
Jinan, Shandong, 250117
Study Coordinator, 0531-87984777
- Recruiting
Liuzhou People's Hospital ( Site 2029)
Liuzhou, Guangxi, 545006
Study Coordinator, 0772-3612345
- Recruiting
The First Affiliated Hospital of Nanchang University ( Site 2023)
Nanchang, Jiangxi, 330006
Study Coordinator, 0791-88695051
- Recruiting
Jiangxi Provincial Cancer Hospital ( Site 2009)
Nanchang, Jiangxi, 330029
Study Coordinator, 079188329441
- Recruiting
Jiangsu Province Hospital ( Site 2000)
Nanjing, Jiangsu, 210029
Study Coordinator, 025-68307358
- Recruiting
Guangxi Medical University Affiliated Tumor Hospital ( Site 2004)
Nanning, Guangxi, 530200
Study Coordinator, 0771-5313603
- Recruiting
The First Affliated Hospital of Suzhou University ( Site 2027)
Suzhou, Jiangsu, 215000
Study Coordinator, 0512-67972858
- Recruiting
Shanxi Cancer Hospital ( Site 2033)
Taiyuan, Shanxi, 030000
Study Coordinator, 0351-4651037
- Recruiting
Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 2019)
Tianjin, Tianjin Municipality, 300060
Study Coordinator, 022-23340123-2071
- Recruiting
Institute of hematology&blood disease hospital-Lymphoma ( Site 2005)
Tianjin, Tianjin Municipality, 301617
Study Coordinator, 022-23608110
- Recruiting
Xinjiang Medical University Cancer Hospital - Urumqi ( Site 2014)
Ürümqi, Xinjiang, 830000
Study Coordinator, 0991-7968088
- Recruiting
Tongji Hospital Affiliated to Tongji Medical College of HUST ( Site 2016)
Wuhan, Hubei, 430000
Study Coordinator, 02783662640
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 2015)
Wuhan, Hubei, 430058
Study Coordinator, 02784397521
- Recruiting
Shaanxi provincial people's hospital ( Site 2012)
Xi'an, Shaanxi, 710068
Study Coordinator, 029-85251331
- Recruiting
The Affiliated Hospital of Xuzhou Medical College ( Site 2013)
Xuzhou, Jiangsu, 221006
Study Coordinator, 051685802369
- Recruiting
Henan Cancer Hospital-hematology department ( Site 2025)
Zhengzhou, Henan, 450008
Study Coordinator, 0371-65587305
Japan14 sites
- Active, not recruiting
Chiba Cancer Center ( Site 1905)
Chiba, 260-8717
- Completed
Kyushu University Hospital ( Site 1914)
Fukuoka, 812-8582
- Active, not recruiting
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital ( Site 1913)
Hiroshima, 730-8619
- Active, not recruiting
Shimane University Hospital ( Site 1911)
Izumo, Shimane, 693-8501
- Active, not recruiting
Kobe City Medical Center General Hospital ( Site 1910)
Kobe, Hyōgo, 650-0047
- Active, not recruiting
Cancer Institute Hospital of JFCR ( Site 1906)
Koto, Tokyo, 135-8550
- Active, not recruiting
Gunma University Hospital ( Site 1903)
Maebashi, Gunma, 371-8511
- Active, not recruiting
Nagoya University Hospital ( Site 1907)
Nagoya, Aichi-ken, 466-8560
- Active, not recruiting
Okayama University Hospital ( Site 1912)
Okayama, 700-8558
- Active, not recruiting
Japanese Red Cross Osaka Hospital ( Site 1908)
Osaka, 543-8555
- Active, not recruiting
Kindai University Hospital ( Site 1909)
Sakai, Osaka, 590-0197
- Active, not recruiting
Hokkaido University Hospital ( Site 1900)
Sapporo, Hokkaido, 060-8648
- Active, not recruiting
Tohoku University Hospital ( Site 1901)
Sendai, Miyagi, 980-8574
- Active, not recruiting
Yamagata University Hospital ( Site 1902)
Yamagata, 990-9585
United Kingdom10 sites, 7 recruiting
- Recruiting
Barnet Hospital ( Site 3005)
Barnet, EN5 3DJ
Study Coordinator, 0208 216 4755
- Completed
Southmead Hospital ( Site 3010)
Bristol, Bristol, City of, BS10 5NB
- Recruiting
GenesisCare - Bristol ( Site 3011)
Bristol, South Gloucestershire, BS32 4SY
Study Coordinator, +441173421121
- Completed
Royal Lancaster Infirmary ( Site 3012)
Lancaster, Lancashire, LA1 4RP
- Recruiting
St James's University Hospital ( Site 3004)
Leeds, LS9 7TF
Study Coordinator, +441132432799
- Recruiting
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3006)
London, London, City of, EC1A 7BE
Study Coordinator, +442073777000
- Recruiting
GenesisCare - Cambridge ( Site 3001)
Newmarket, Suffolk, CB8 7XN
Study Coordinator, 01223 907622
- Completed
City Hospital, Nottingham University Hospitals NHS Trust ( Site 3003)
Nottingham, NG5 1PB
- Recruiting
The Churchill Hospital ( Site 3007)
Oxford, Oxfordshire, OX3 7LE
Study Coordinator, 441865235886
- Recruiting
GenesisCare - Windsor ( Site 3002)
Windsor, Windsor And Maidenhead, SL4 3HD
Study Coordinator, 447989474250
Turkey (Türkiye)9 sites, 8 recruiting
- Recruiting
Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 1401)
Ankara, 06100
Study Coordinator, +90312 310 33 33
- Recruiting
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1407)
Ankara, 06800
Study Coordinator, +90 312 552 60 00
- Recruiting
Antalya Egitim ve Arastırma Hastanesi ( Site 1409)
Antalya, 7100
Study Coordinator, +90 242 2494400-4143
- Recruiting
Trakya University Medical Faculty Hospital-Hematology ( Site 1403)
Edirne, 22030
Study Coordinator, +905438561362
- Recruiting
Mega Medipol ( Site 1412)
Istanbul, 34214
Study Coordinator, +90 5077078197
- Recruiting
Sisli Florence Nightingale Hastanesi ( Site 1411)
Istanbul, 34381
Study Coordinator, +90444 04 36
- Completed
Marmara Universitesi Pendik Egitim Arastirma Hastanesi ( Site 1408)
Istanbul, 34899
- Recruiting
Ege Universitesi Hastanesi ( Site 1404)
Izmir, 35100
Study Coordinator, +905325566128
- Recruiting
Ondokuz Mays Üniversitesi ( Site 1410)
Samsun, 55280
Study Coordinator, +903624576041
Poland8 sites, 7 recruiting
- Recruiting
Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 1011)
Gdansk, Pomeranian Voivodeship, 80-214
Study Coordinator, +48 58 584 43 57
- Recruiting
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1000)
Gliwice, Silesian Voivodeship, 44-102
Study Coordinator, +48322788523
- Recruiting
Pratia Onkologia Katowice ( Site 1009)
Katowice, Silesian Voivodeship, 40-519
Study Coordinator, +48501714019
- Recruiting
Pratia MCM Krakow ( Site 1007)
Krakow, Lesser Poland Voivodeship, 30-727
Study Coordinator, 0048602338290
- Recruiting
Uniwersytecki Szpital Kliniczny nr 1 w Lublinie-Oddział Hematoonkologii-Transplantacji Szpiku i Chem ( Site 1006)
Lublin, Lublin Voivodeship, 20-081
Study Coordinator, +48 81 534 54 68
- Recruiting
Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA w Olsztynie-Oddzial Kliniczny Hematologii ( Site 1005)
Olsztyn, Warmian-Masurian Voivodeship, 10-228
Study Coordinator, 48895398133
- Completed
Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku-Oddział Hematologii i Transplantacji ( Site 1013)
Słupsk, Pomeranian Voivodeship, 76-200
- Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site 1004)
Warsaw, Masovian Voivodeship, 02-781
Study Coordinator, +48225462223
Israel7 sites, 7 recruiting
- Recruiting
Rambam Health Care Campus-Hematology and Bone Marrow Transplantation ( Site 1503)
Haifa, 3109601
Study Coordinator, 04-7771514
- Recruiting
Bnai Zion Medical Center ( Site 1505)
Haifa, 3339419
Study Coordinator, 972506268114
- Recruiting
Hadassah Medical Center-Hemato-Oncology ( Site 1500)
Jerusalem, 9112001
Study Coordinator, 972-56-9101736
- Recruiting
Galilee Medical Center ( Site 1507)
Nahariya, 2201202
Study Coordinator, +97249107260
- Recruiting
Rabin Medical Center ( Site 1504)
Petah Tikva, 4941492
Study Coordinator, 972-54-2200162
- Recruiting
Sheba Medical Center-Hemato Oncology ( Site 1501)
Ramat Gan, 5265601
Study Coordinator, +972-35308401
- Recruiting
Yitzhak Shamir Medical Center. ( Site 1506)
Ẕerifin, 7033001
Study Coordinator, 972-8-9542443
Spain7 sites, 7 recruiting
- Recruiting
HOSPITAL CLÍNIC DE BARCELONA ( Site 1202)
Barcelona, Catalonia, 08036
Study Coordinator, +34 619085109
- Recruiting
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1206)
Barcelona, 08035
Study Coordinator, +34 934893806
- Recruiting
Institut Català d'Oncologia - L'Hospitalet-Haematology Department ( Site 1207)
L'Hospitalet Del Llobregat, Barcelona, 08908
Study Coordinator, + 34 932607750
- Recruiting
HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 1208)
Majadahonda, Madrid, Comunidad de, 28222
Study Coordinator, +34 911917620
- Recruiting
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1209)
Pozuelo de Alarcón, Madrid, 28223
Study Coordinator, +34 914521900
- Recruiting
Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 1201)
Salamanca, 37007
Study Coordinator, 923291100 Ext. 55014
- Recruiting
hospital universitario de canarias ( Site 1205)
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
Study Coordinator, +34922678207
Canada6 sites, 5 recruiting
- Recruiting
William Osler Health System ( Site 0103)
Brampton, Ontario, L6R 3J7
Study Coordinator, 905-494-2120
- Recruiting
BC Cancer Kelowna ( Site 0112)
Kelowna, British Columbia, V1Y 5L3
Study Coordinator, 250-717-4294
- Recruiting
McGill University Health Centre ( Site 0106)
Montreal, Quebec, H4A 3J1
Study Coordinator, 514-934-1934
- Recruiting
The Ottawa Hospital - General Campus ( Site 0102)
Ottawa, Ontario, K1H 8L6
Study Coordinator, 613-737-8899 x79509
- Completed
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0100)
Rimouski, Quebec, G5L 5T1
- Recruiting
BC Cancer Victoria ( Site 0109)
Victoria, British Columbia, V8R 6V5
Study Coordinator, 250-519-5500
Germany6 sites, 6 recruiting
- Recruiting
Onkologische Schwerpunktpraxis Kurfuerstendamm ( Site 0600)
Berlin, 10707
Study Coordinator, +4930887742570
- Recruiting
Universitätsklinikum Halle ( Site 0604)
Halle, Saxony-Anhalt, 06120
Study Coordinator, +493455572054
- Recruiting
InVO Institut für Versorgungsforschung in der Onkologie ( Site 0606)
Koblenz, Rhineland-Palatinate, 56068
Study Coordinator, +4926192156930
- Recruiting
VK&K Studien GbR ( Site 0607)
Landshut, Bavaria, 84036
Study Coordinator, +4987197403429
- Recruiting
Kliniken Maria Hilf ( Site 0603)
Mönchengladbach, North Rhine-Westphalia, 41063
Study Coordinator, +4921618922201
- Recruiting
Universitaetsklinikum Ulm. ( Site 0601)
Ulm, Baden-Wurttemberg, 89081
Study Coordinator, +497315000
Portugal6 sites, 6 recruiting
- Recruiting
Instituto Português de Oncologia de Lisboa Francisco Gentil ( Site 3103)
Lisbon, Lisbon District, 1099-023
Study Coordinator, 00351217229800
- Recruiting
Champalimaud Foundation ( Site 3102)
Lisbon, Lisbon District, 1400-038
Study Coordinator, 00351210480200
- Recruiting
Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 3104)
Lisbon, 1449-005
Study Coordinator, 00351210431703
- Recruiting
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 3106)
Lisbon, 1649-035
Study Coordinator, +351217805000
- Recruiting
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 3100)
Porto, 4200-072
Study Coordinator, 00351225084000
- Recruiting
Unidade Local de Saude Gaia/Espinho - Hospital Eduardo Santos Silva ( Site 3107)
Vila Nova de Gaia, Porto District, 4434-502
Study Coordinator, 00351227865100
Brazil5 sites, 5 recruiting
- Recruiting
Hospital Erasto Gaertner ( Site 2212)
Curitiba, Paraná, 81520-060
Study Coordinator, +55 (41) 33615195
- Recruiting
Hope - Humanizacao Em Oncologia, Pesquisa E Ensino ( Site 2211)
Ribeirão Preto, São Paulo, 14026-610
Study Coordinator, +55 16 98813-0059
- Recruiting
Instituto Nacional de Câncer - INCA ( Site 2201)
Rio de Janeiro, 20230-130
Study Coordinator, +2132076585
- Recruiting
Hospital 9 De Julho ( Site 2206)
São Paulo, São Paulo, 01409-001
Study Coordinator, 55 11 3147 9432
- Recruiting
Hospital Paulistano-Americas Oncologia ( Site 2202)
São Paulo, 01321-001
Study Coordinator, 55 11 11 3141-1083
South Africa5 sites, 5 recruiting
- Recruiting
Groote Schuur Hospital-Clinical Haematology ( Site 1100)
Cape Town, Western Cape, 7925
Study Coordinator, +27727689024
- Recruiting
Wits Clinical Research ( Site 1102)
Johannesburg, Gauteng, 1864
Study Coordinator, +27119836501
- Recruiting
Haemalife ( Site 1105)
Kuilsriver, Western Cape, 7580
Study Coordinator, +27219006277
- Recruiting
Constantiaberg Haematology ( Site 1106)
Plumstead, Western Cape, 7800
Study Coordinator, 0217992558
- Recruiting
Netcare Pretoria East Hospital-Alberts Cellular Therapy ( Site 1101)
Pretoria, Gauteng, 0181
Study Coordinator, +27 12 993 2555
Thailand5 sites, 5 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital-Division of Hematology, Department of Medicine ( Site 1801)
Bangkok, Bangkok, 10700
Study Coordinator, +6624197767
- Recruiting
Songklanagarind hospital ( Site 1803)
Hat Yai, Changwat Songkhla, 90110
Study Coordinator, 6674451735
- Recruiting
Naresuan University Hospital ( Site 1804)
Muang, Changwat Phitsanulok, 65000
Study Coordinator, +6655965777
- Recruiting
Maharaj Nakorn Chiang Mai Hospital ( Site 1800)
Muang, Chiang Mai, 50200
Study Coordinator, 6653935488
- Recruiting
Chulalongkorn University ( Site 1802)
Pathumwan, Bangkok, 10330
Study Coordinator, +6624197767
Greece4 sites, 4 recruiting
- Recruiting
University Hospital of Alexandroupolis ( Site 0701)
Alexandroupoli, East Macedonia and Thrace, 681 00
Study Coordinator, 0030 2551353739
- Recruiting
Evangelismos General Hospital of Athens ( Site 0700)
Athens, Attica, 106 76
Study Coordinator, 0030 2132041721
- Recruiting
General Hospital of Athens "Laiko" ( Site 0704)
Athens, Attica, 115 26
Study Coordinator, 0030 2132061643
- Recruiting
University Hospital of Ioannina ( Site 0702)
Ioannina, 455 00
Study Coordinator, +302651099647
Taiwan4 sites, 4 recruiting
- Recruiting
Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 1702)
Kaohsiung City, 833
Study Coordinator, +88677317123
- Recruiting
National Cheng Kung University Hospital ( Site 1700)
Tainan, 704302
Study Coordinator, +88662752037
- Recruiting
National Taiwan University Hospital ( Site 1701)
Taipei, 10048
Study Coordinator, +886972652039
- Recruiting
Chang Gung Medical Foundation-Linkou Branch ( Site 1703)
Taoyuan, 33305
Study Coordinator, +88633281200
Chile3 sites, 3 recruiting
- Recruiting
FALP-UIDO ( Site 2300)
Santiago, Region M. de Santiago, 7500921
Study Coordinator, 56224205098
- Recruiting
Clínica Alemana de Santiago-Unidad de Investigaciones ( Site 2306)
Santiago, Region M. de Santiago, 7650568
Study Coordinator, 56222101111 (6218)
- Recruiting
Bradfordhill-Clinical Area ( Site 2310)
Santiago, Region M. de Santiago, 8420383
Study Coordinator, 56229490970
Colombia3 sites, 3 recruiting
- Recruiting
Fundacion Valle del Lili- CIC-Oncology CIC ( Site 2402)
Cali, Valle del Cauca Department, 760032
Study Coordinator, +576023319090 - 4022
- Recruiting
IMAT S.A.S ( Site 2401)
Montería, Departamento de Córdoba, 230002
Study Coordinator, +57 3135342052
- Recruiting
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 2405)
Valledupar, Cesar Department, 200001
Study Coordinator, +57 315 8505190
Czechia3 sites, 3 recruiting
- Recruiting
Fakultni nemocnice Hradec Kralove-IV. interni hematologicka klinika ( Site 0301)
Hradec Králové, 500 05
Study Coordinator, +420 777846836
- Recruiting
Fakultni nemocnice Olomouc ( Site 0303)
Olomouc, 779 00
Study Coordinator, +420588443940
- Recruiting
Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0302)
Prague, 128 08
Study Coordinator, +420224962527
Denmark3 sites, 3 recruiting
- Recruiting
Aalborg Universitetshospital, Syd ( Site 0403)
Aalborg, North Denmark, 9000
Study Coordinator, +45 97660000
- Recruiting
Sjællands Universitetshospital Køge ( Site 0402)
Koege, Region Sjælland, 4600
Study Coordinator, +4556631500
- Recruiting
Odense Universitetshospital-Department of Hematology ( Site 0401)
Odense C, Region Syddanmark, 5000
Study Coordinator, +4566613333
Malaysia3 sites, 3 recruiting
- Recruiting
Hospital Pulau Pinang ( Site 1602)
George Town, Pulau Pinang, 10450
Study Coordinator, +6042225767
- Recruiting
Queen Elizabeth Hospital ( Site 1603)
Kota Kinabalu, Sabah, 88586
Study Coordinator, +6088517555
- Recruiting
University Malaya Medical Centre ( Site 1604)
Lembah Pantai, Kuala Lumpur, 59100
Study Coordinator, +60479492351
Mexico3 sites, 2 recruiting
- Recruiting
Grupo Médico ASSET SC ( Site 2611)
Benito Juárez, Mexico City, 03100
Study Coordinator, +525516217417
- Recruiting
Centro de Infusion Superare ( Site 2602)
Mexico City, Mexico City, 03100
Study Coordinator, 5525020124
- Completed
Health Pharma Professional Research S.A. de C.V: ( Site 2608)
Mexico City, Mexico City, 03100
New Zealand3 sites, 3 recruiting
- Recruiting
North Shore Hospital-Department of Haematology ( Site 3200)
Auckland, 0622
Study Coordinator, +64 9 486 8930
- Recruiting
Aotearoa Clinical Trials ( Site 3201)
Auckland, 2025
Study Coordinator, (+64)0800272784
- Recruiting
Waikato Hospital-Haematology ( Site 3202)
Hamilton, Waikato Region, 3240
Study Coordinator, +64 7 839 8899
Norway3 sites, 3 recruiting
- Recruiting
Akershus Universitetssykehus ( Site 0902)
Lørenskog, Akershus, 1474
Study Coordinator, +4767 96 00 00
- Recruiting
Oslo Universitetssykehus Rikshospitalet-Avdeling for blodsykdommer ( Site 0901)
Oslo, 0372
Study Coordinator, +4791502770
- Recruiting
Sykehuset i Vestfold ( Site 0903)
Tønsberg, Vestfold, 3103
Study Coordinator, +4733342000
Belgium2 sites, 2 recruiting
- Recruiting
UZ Leuven-Hematology ( Site 0200)
Leuven, Vlaams-Brabant, 3000
Study Coordinator, +3216332211
- Recruiting
AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0205)
Mechelen, Antwerpen, 2800
Study Coordinator, +3215892080
Peru2 sites, 2 recruiting
- Recruiting
Centro Medico Monte Carmelo-Oncology ( Site 2706)
Arequipa, Ariqipa, 054
Study Coordinator, +51980728089
- Recruiting
Clínica Anglo Americana ( Site 2701)
Lima, 15073
Study Coordinator, +5116168900
Australia1 site
- Completed
Royal North Shore Hospital ( Site 2806)
St Leonards, New South Wales, 2065
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital ( Site 3300)
Hong Kong
Study Coordinator, +852 2255 3838
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Universitetssjukhuset Solna ( Site 1302)
Stockholm, Stockholm County, 171 64
Study Coordinator, +46812370000
About this study
Official title: 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)
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.
- Being tested
- Nemtabrutinib, Ibrutinib, Acalabrutinib
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NemtabrutinibDrug
Also called MK-1026, ARQ 531
Administered orally
IbrutinibDrug
Administered orally
AcalabrutinibDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Nemtabrutinib | Experimental | Participants will receive nemtabrutinib at specified dose until disease progression, unacceptable toxicity or until discontinuation criteria are met. Receives: Drug: Nemtabrutinib |
| Ibrutinib/Acalabrutinib | Active comparator | Participants will receive investigator's choice of ibrutinib or acalabrutinib at specified dose until disease progression, unacceptable toxicity or until discontinuation criteria are met. Receives: Drug: Ibrutinib; Drug: Acalabrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) per Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as assessed by Blinded Independent Central Review (BICR)
ORR is defined as the percentage of participants with complete response (CR), complete response with an incomplete recovery of the participant's bone marrow (CRi), nodular partial response (nPR), or partial response (PR), per iwCLL Criteria 2018 as assessed by BICR.
Measured: Up to approximately 44 months
Progression-Free Survival (PFS) per iwCLL Criteria 2018 as assessed by BICR
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PD is evaluated per iwCLL Criteria 2018 as assessed by BICR.
Measured: Up to approximately 104 months
Secondary outcomes (4)
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Measured: Up to approximately 104 months
Duration of Response (DOR) per iwCLL Criteria 2018 as assessed by BICR
For participants who demonstrate a complete response (CR), complete response with an incomplete recovery of the participant's bone marrow (CRi), nodular partial response (nPR), or partial response (PR) per iwCLL Criteria 2018 as assessed by BICR, DOR is defined as the time from the first documented evidence of CR, CRi, nPR, or PR that led to response until disease progression or death due to any cause, whichever occurs first.
Measured: Up to approximately 104 months
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Up to approximately 104 months
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Up to approximately 104 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start13 Dec 2023
- Primary completion7 Sep 2032 (estimated)
- Study completion7 Sep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136559
- Sponsor's protocol ID
- 1026-011
- Other IDs
- 2022-501697-19-00, U1111-1281-7895, MK-1026-011, BELLWAVE-011, jRCT2031230697
- Status last verified
- Oct 2026
- First submitted
- 13 Nov 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf