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)

May 26, 2026 updated by: Merck Sharp & Dohme LLC

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • St Leonards, New South Wales, Australia, 2065
        • Completed
        • Royal North Shore Hospital ( Site 2806)
  • Belgium
    • Antwerpen
      • Mechelen, Antwerpen, Belgium, 2800
        • Recruiting
        • AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0205)
        • Contact:
          • Study Coordinator
          • Phone Number: +3215892080
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • UZ Leuven-Hematology ( Site 0200)
        • Contact:
          • Study Coordinator
          • Phone Number: +3216332211
  • Brazil
      • Rio de Janeiro, Brazil, 20230-130
        • Recruiting
        • Instituto Nacional de Câncer - INCA ( Site 2201)
        • Contact:
          • Study Coordinator
          • Phone Number: +2132076585
      • São Paulo, Brazil, 01321-001
        • Recruiting
        • Hospital Paulistano-Americas Oncologia ( Site 2202)
        • Contact:
          • Study Coordinator
          • Phone Number: 55 11 11 3141-1083
    • São Paulo
      • São Paulo, São Paulo, Brazil, 01409-001
        • Recruiting
        • Hospital 9 De Julho ( Site 2206)
        • Contact:
          • Study Coordinator
          • Phone Number: 55 11 3147 9432
  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • Recruiting
        • BC Cancer Kelowna ( Site 0112)
        • Contact:
          • Study Coordinator
          • Phone Number: 250-717-4294
      • Victoria, British Columbia, Canada, V8R 6V5
        • Recruiting
        • BC Cancer Victoria ( Site 0109)
        • Contact:
          • Study Coordinator
          • Phone Number: 250-519-5500
    • Ontario
      • Brampton, Ontario, Canada, L6R 3J7
        • Recruiting
        • William Osler Health System ( Site 0103)
        • Contact:
          • Study Coordinator
          • Phone Number: 905-494-2120
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • The Ottawa Hospital - General Campus ( Site 0102)
        • Contact:
          • Study Coordinator
          • Phone Number: 613-737-8899 x79509
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre ( Site 0106)
        • Contact:
          • Study Coordinator
          • Phone Number: 514-934-1934
      • Rimouski, Quebec, Canada, G5L 5T1
        • Completed
        • Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0100)
  • Chile
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7500921
        • Recruiting
        • FALP-UIDO ( Site 2300)
        • Contact:
          • Study Coordinator
          • Phone Number: 56224205098
      • Santiago, Region M. de Santiago, Chile, 7650568
        • Recruiting
        • Clínica Alemana de Santiago-Unidad de Investigaciones ( Site 2306)
        • Contact:
          • Study Coordinator
          • Phone Number: 56222101111 (6218)
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Recruiting
        • Bradfordhill-Clinical Area ( Site 2310)
        • Contact:
          • Study Coordinator
          • Phone Number: 56229490970
  • China
    • Anhui
      • Hefei, Anhui, China, 230031
        • Recruiting
        • Anhui Provincial Cancer Hospital Clinical Trial Ethics Committee ( Site 2001)
        • Contact:
          • Study Coordinator
          • Phone Number: 0551-65329163
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Recruiting
        • Peking University First Hospital ( Site 2022)
        • Contact:
          • Study Coordinator
          • Phone Number: 010-83575680
      • Beijing, Beijing Municipality, China, 100191
        • Recruiting
        • Peking University Third Hospital-Hematology ( Site 2011)
        • Contact:
          • Study Coordinator
          • Phone Number: 010-82264404
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400030
        • Recruiting
        • Chongqing University Cancer Hospital ( Site 2041)
        • Contact:
          • Study Coordinator
          • Phone Number: 02365079270
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 2006)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 02062786845
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center ( Site 2028)
        • Contact:
          • Study Coordinator
          • Phone Number: 020-87343886
    • Guangxi
      • Liuzhou, Guangxi, China, 545006
        • Recruiting
        • Liuzhou People's Hospital ( Site 2029)
        • Contact:
          • Study Coordinator
          • Phone Number: 0772-3612345
      • Nanning, Guangxi, China, 530200
        • Recruiting
        • Guangxi Medical University Affiliated Tumor Hospital ( Site 2004)
        • Contact:
          • Study Coordinator
          • Phone Number: 0771-5313603
    • Guizhou
      • Guiyang, Guizhou, China, 550004
        • Recruiting
        • The Affiliated Hospital of Guizhou Medical University ( Site 2024)
        • Contact:
          • Study Coordinator
          • Phone Number: 0851-86740793
    • Hainan
      • Haikou, Hainan, China, 570311
        • Recruiting
        • Hainan General Hospital ( Site 2018)
        • Contact:
          • Study Coordinator
          • Phone Number: (0898)68622479
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Henan Cancer Hospital-hematology department ( Site 2025)
        • Contact:
          • Study Coordinator
          • Phone Number: 0371-65587305
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Tongji Hospital Affiliated to Tongji Medical College of HUST ( Site 2016)
        • Contact:
          • Study Coordinator
          • Phone Number: 02783662640
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Ethics Committee of Union Hospital Tongji Medical College Huazhong University of Science and Technol ( Site 2015)
        • Contact:
          • Study Coordinator
          • Phone Number: 02784397521
    • Hunan
      • Changsha, Hunan, China, 410011
        • Recruiting
        • The Second Xiangya Hospital of Central South University ( Site 2010)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 073185292097
      • Changsha, Hunan, China, 410006
        • Recruiting
        • Hunan Cancer Hospital ( Site 2020)
        • Contact:
          • Study Coordinator
          • Phone Number: 0731-89762281
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Jiangsu Province Hospital ( Site 2000)
        • Contact:
          • Study Coordinator
          • Phone Number: 025-68307358
      • Suzhou, Jiangsu, China, 215000
        • Recruiting
        • The First Affliated Hospital of Suzhou University ( Site 2027)
        • Contact:
          • Study Coordinator
          • Phone Number: 0512-67972858
      • Xuzhou, Jiangsu, China, 221006
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical College ( Site 2013)
        • Contact:
          • Study Coordinator
          • Phone Number: 051685802369
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The First Affiliated Hospital of Nanchang University ( Site 2023)
        • Contact:
          • Study Coordinator
          • Phone Number: 0791-88695051
      • Nanchang, Jiangxi, China, 330029
        • Recruiting
        • Jiangxi Provincial Cancer Hospital ( Site 2009)
        • Contact:
          • Study Coordinator
          • Phone Number: 079188329441
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • The First Hospital of Jilin University-Hematology ( Site 2030)
        • Contact:
          • Study Coordinator
          • Phone Number: 0431-81879901
    • Shaanxi
      • Xi'an, Shaanxi, China, 710068
        • Recruiting
        • Shaanxi provincial people's hospital ( Site 2012)
        • Contact:
          • Study Coordinator
          • Phone Number: 029-85251331
    • Shandong
      • Jinan, Shandong, China, 250117
        • Recruiting
        • Shandong Cancer Hospital ( Site 2003)
        • Contact:
          • Study Coordinator
          • Phone Number: 0531-87984777
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
        • Recruiting
        • Shanxi Cancer Hospital ( Site 2033)
        • Contact:
          • Study Coordinator
          • Phone Number: 0351-4651037
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University-Head and Neck Oncology ( Site 2026)
        • Contact:
          • Study Coordinator
          • Phone Number: 02885423278
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 2019)
        • Contact:
          • Study Coordinator
          • Phone Number: 022-23340123-2071
      • Tianjin, Tianjin Municipality, China, 301617
        • Recruiting
        • Institute of hematology&blood disease hospital-Lymphoma ( Site 2005)
        • Contact:
          • Study Coordinator
          • Phone Number: 022-23608110
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830000
        • Recruiting
        • Xinjiang Medical University Cancer Hospital - Urumqi ( Site 2014)
        • Contact:
          • Study Coordinator
          • Phone Number: 0991-7968088
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital ( Site 2017)
        • Contact:
          • Study Coordinator
          • Phone Number: 0571-88122198
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The first Affiliated Hospital, Zhejiang University School of Medicine-Hematology ( Site 2002)
        • Contact:
          • Study Coordinator
          • Phone Number: 057187236114
  • Colombia
    • Cesar Department
      • Valledupar, Cesar Department, Colombia, 200001
        • Recruiting
        • Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 2405)
        • Contact:
          • Study Coordinator
          • Phone Number: +57 315 8505190
    • Departamento de Córdoba
      • Montería, Departamento de Córdoba, Colombia, 230002
        • Recruiting
        • IMAT S.A.S ( Site 2401)
        • Contact:
          • Study Coordinator
          • Phone Number: +57 3135342052
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Colombia, 760032
        • Recruiting
        • Fundacion Valle del Lili- CIC-Oncology CIC ( Site 2402)
        • Contact:
          • Study Coordinator
          • Phone Number: +576023319090 - 4022
  • Czechia
      • Hradec Králové, Czechia, 500 05
        • Recruiting
        • Fakultni nemocnice Hradec Kralove-IV. interni hematologicka klinika ( Site 0301)
        • Contact:
          • Study Coordinator
          • Phone Number: +420 777846836
      • Olomouc, Czechia, 779 00
        • Recruiting
        • Fakultni nemocnice Olomouc ( Site 0303)
        • Contact:
          • Study Coordinator
          • Phone Number: +420588443940
      • Prague, Czechia, 128 08
        • Recruiting
        • Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0302)
        • Contact:
          • Study Coordinator
          • Phone Number: +420224962527
  • Denmark
    • North Denmark
      • Aalborg, North Denmark, Denmark, 9000
        • Recruiting
        • Aalborg Universitetshospital, Syd ( Site 0403)
        • Contact:
          • Study Coordinator
          • Phone Number: +45 97660000
    • Region Sjælland
      • Roskilde, Region Sjælland, Denmark, 4000
        • Recruiting
        • Roskilde Sygehus-Department of Hematology ( Site 0402)
        • Contact:
          • Study Coordinator
          • Phone Number: +45 46323200
    • Region Syddanmark
      • Odense C, Region Syddanmark, Denmark, 5000
        • Recruiting
        • Odense Universitetshospital-Department of Hematology ( Site 0401)
        • Contact:
          • Study Coordinator
          • Phone Number: +4566613333
  • Germany
      • Berlin, Germany, 10707
        • Recruiting
        • Onkologische Schwerpunktpraxis Kurfuerstendamm ( Site 0600)
        • Contact:
          • Study Coordinator
          • Phone Number: +4930887742570
    • Baden-Wurttemberg
      • Ulm, Baden-Wurttemberg, Germany, 89081
        • Recruiting
        • Universitaetsklinikum Ulm. ( Site 0601)
        • Contact:
          • Study Coordinator
          • Phone Number: +497315000
    • Bavaria
      • Landshut, Bavaria, Germany, 84036
        • Recruiting
        • VK&K Studien GbR ( Site 0607)
        • Contact:
          • Study Coordinator
          • Phone Number: +4987197403429
    • North Rhine-Westphalia
      • Mönchengladbach, North Rhine-Westphalia, Germany, 41063
        • Recruiting
        • Kliniken Maria Hilf ( Site 0603)
        • Contact:
          • Study Coordinator
          • Phone Number: +4921618922201
    • Rhineland-Palatinate
      • Koblenz, Rhineland-Palatinate, Germany, 56068
        • Recruiting
        • InVO Institut für Versorgungsforschung in der Onkologie ( Site 0606)
        • Contact:
          • Study Coordinator
          • Phone Number: +4926192156930
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Germany, 06120
        • Recruiting
        • Universitätsklinikum Halle ( Site 0604)
        • Contact:
          • Study Coordinator
          • Phone Number: +493455572054
  • Greece
      • Ioannina, Greece, 455 00
        • Recruiting
        • University Hospital of Ioannina ( Site 0702)
        • Contact:
          • Study Coordinator
          • Phone Number: +302651099647
    • Attica
      • Athens, Attica, Greece, 106 76
        • Recruiting
        • Evangelismos General Hospital of Athens ( Site 0700)
        • Contact:
          • Study Coordinator
          • Phone Number: 0030 2132041721
      • Athens, Attica, Greece, 115 26
        • Recruiting
        • General Hospital of Athens "Laiko" ( Site 0704)
        • Contact:
          • Study Coordinator
          • Phone Number: 0030 2132061643
    • East Macedonia and Thrace
      • Alexandroupoli, East Macedonia and Thrace, Greece, 681 00
        • Recruiting
        • University Hospital of Alexandroupolis ( Site 0701)
        • Contact:
          • Study Coordinator
          • Phone Number: 0030 2551353739
  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital ( Site 3300)
        • Contact:
          • Study Coordinator
          • Phone Number: +852 2255 3838
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus-Hematology and Bone Marrow Transplantation ( Site 1503)
        • Contact:
          • Study Coordinator
          • Phone Number: 04-7771514
      • Haifa, Israel, 3339419
        • Recruiting
        • Bnai Zion Medical Center ( Site 1505)
        • Contact:
          • Study Coordinator
          • Phone Number: 972506268114
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center-Hemato-Oncology ( Site 1500)
        • Contact:
          • Study Coordinator
          • Phone Number: 972-56-9101736
      • Nahariya, Israel, 2201202
        • Recruiting
        • Galilee Medical Center ( Site 1507)
        • Contact:
          • Study Coordinator
          • Phone Number: +97249107260
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center ( Site 1504)
        • Contact:
          • Study Coordinator
          • Phone Number: 972-54-2200162
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center-Hemato Oncology ( Site 1501)
        • Contact:
          • Study Coordinator
          • Phone Number: +972-35308401
      • Ẕerifin, Israel, 7033001
        • Recruiting
        • Yitzhak Shamir Medical Center. ( Site 1506)
        • Contact:
          • Study Coordinator
          • Phone Number: 972-8-9542443
  • Japan
      • Chiba, Japan, 260-8717
        • Active, not recruiting
        • Chiba Cancer Center ( Site 1905)
      • Fukuoka, Japan, 812-8582
        • Completed
        • Kyushu University Hospital ( Site 1914)
      • Hiroshima, Japan, 730-8619
        • Active, not recruiting
        • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital ( Site 1913)
      • Okayama, Japan, 700-8558
        • Active, not recruiting
        • Okayama University Hospital ( Site 1912)
      • Osaka, Japan, 543-8555
        • Active, not recruiting
        • Japanese Red Cross Osaka Hospital ( Site 1908)
      • Yamagata, Japan, 990-9585
        • Active, not recruiting
        • Yamagata University Hospital ( Site 1902)
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 466-8560
        • Active, not recruiting
        • Nagoya University Hospital ( Site 1907)
    • Gunma
      • Maebashi, Gunma, Japan, 371-8511
        • Active, not recruiting
        • Gunma University Hospital ( Site 1903)
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Active, not recruiting
        • Hokkaido University Hospital ( Site 1900)
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0047
        • Active, not recruiting
        • Kobe City Medical Center General Hospital ( Site 1910)
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Active, not recruiting
        • Tohoku University Hospital ( Site 1901)
    • Osaka
      • Sakai, Osaka, Japan, 590-0197
        • Active, not recruiting
        • Kindai University Hospital ( Site 1909)
    • Shimane
      • Izumo, Shimane, Japan, 693-8501
        • Active, not recruiting
        • Shimane University Hospital ( Site 1911)
    • Tokyo
      • Koto, Tokyo, Japan, 135-8550
        • Active, not recruiting
        • Cancer Institute Hospital of JFCR ( Site 1906)
  • Malaysia
    • Kuala Lumpur
      • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • University Malaya Medical Centre ( Site 1604)
        • Contact:
          • Study Coordinator
          • Phone Number: +60479492351
    • Pulau Pinang
      • George Town, Pulau Pinang, Malaysia, 10450
        • Recruiting
        • Hospital Pulau Pinang ( Site 1602)
        • Contact:
          • Study Coordinator
          • Phone Number: +6042225767
    • Sabah
      • Kota Kinabalu, Sabah, Malaysia, 88586
        • Recruiting
        • Queen Elizabeth Hospital ( Site 1603)
        • Contact:
          • Study Coordinator
          • Phone Number: +6088517555
  • Mexico
      • Mexico City, Mexico, 3100
        • Recruiting
        • Grupo Médico ASSET ( Site 2611)
        • Contact:
          • Study Coordinator
          • Phone Number: +525516217417
    • Mexico City
      • Mexico City, Mexico City, Mexico, 03100
        • Recruiting
        • Centro de Infusion Superare ( Site 2602)
        • Contact:
          • Study Coordinator
          • Phone Number: 5525020124
      • Mexico City, Mexico City, Mexico, 03100
        • Completed
        • Health Pharma Professional Research S.A. de C.V: ( Site 2608)
  • New Zealand
      • Auckland, New Zealand, 0622
        • Recruiting
        • North Shore Hospital-Department of Haematology ( Site 3200)
        • Contact:
          • Study Coordinator
          • Phone Number: +64 9 486 8930
      • Auckland, New Zealand, 2025
        • Recruiting
        • Aotearoa Clinical Trials ( Site 3201)
        • Contact:
          • Study Coordinator
          • Phone Number: (+64)0800272784
    • Waikato Region
      • Hamilton, Waikato Region, New Zealand, 3240
        • Recruiting
        • Waikato Hospital-Haematology ( Site 3202)
        • Contact:
          • Study Coordinator
          • Phone Number: +64 7 839 8899
  • Norway
      • Oslo, Norway, 0372
        • Recruiting
        • Oslo Universitetssykehus Rikshospitalet-Avdeling for blodsykdommer ( Site 0901)
        • Contact:
          • Study Coordinator
          • Phone Number: +4791502770
    • Akershus
      • Lørenskog, Akershus, Norway, 1474
        • Recruiting
        • Akershus Universitetssykehus ( Site 0902)
        • Contact:
          • Study Coordinator
          • Phone Number: +4767 96 00 00
    • Vestfold
      • Tønsberg, Vestfold, Norway, 3103
        • Recruiting
        • Sykehuset i Vestfold ( Site 0903)
        • Contact:
          • Study Coordinator
          • Phone Number: +4733342000
  • Peru
      • Lima, Peru, 15073
        • Recruiting
        • Clínica Anglo Americana ( Site 2701)
        • Contact:
          • Study Coordinator
          • Phone Number: +5116168900
    • Ariqipa
      • Arequipa, Ariqipa, Peru, 054
        • Recruiting
        • Centro Medico Monte Carmelo-Oncology ( Site 2706)
        • Contact:
          • Study Coordinator
          • Phone Number: +51980728089
  • Poland
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-727
        • Recruiting
        • Pratia MCM Krakow ( Site 1007)
        • Contact:
          • Study Coordinator
          • Phone Number: 0048602338290
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-081
        • Recruiting
        • Uniwersytecki Szpital Kliniczny nr 1 w Lublinie-Oddział Hematoonkologii-Transplantacji Szpiku i Chem ( Site 1006)
        • Contact:
          • Study Coordinator
          • Phone Number: +48 81 534 54 68
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-781
        • Recruiting
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site 1004)
        • Contact:
          • Study Coordinator
          • Phone Number: +48225462223
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-214
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 1011)
        • Contact:
          • Study Coordinator
          • Phone Number: +48 58 584 43 57
      • Słupsk, Pomeranian Voivodeship, Poland, 76-200
        • Completed
        • Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku-Oddział Hematologii i Transplantacji ( Site 1013)
    • Silesian Voivodeship
      • Gliwice, Silesian Voivodeship, Poland, 44-101
        • Recruiting
        • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1000)
        • Contact:
          • Study Coordinator
          • Phone Number: +48322788523
      • Katowice, Silesian Voivodeship, Poland, 40-519
        • Recruiting
        • Pratia Onkologia Katowice ( Site 1009)
        • Contact:
          • Study Coordinator
          • Phone Number: +48501714019
    • Warmian-Masurian Voivodeship
      • Olsztyn, Warmian-Masurian Voivodeship, Poland, 10-228
        • Recruiting
        • Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA w Olsztynie-Oddzial Kliniczny Hematologii ( Site 1005)
        • Contact:
          • Study Coordinator
          • Phone Number: 48895398133
  • Portugal
      • Lisbon, Portugal, 1449-005
        • Recruiting
        • Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 3104)
        • Contact:
          • Study Coordinator
          • Phone Number: 00351210431703
      • Lisbon, Portugal, 1649-035
        • Recruiting
        • Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 3106)
        • Contact:
          • Study Coordinator
          • Phone Number: +351217805000
      • Porto, Portugal, 4200-072
        • Recruiting
        • Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 3100)
        • Contact:
          • Study Coordinator
          • Phone Number: 00351225084000
    • Lisbon District
      • Lisbon, Lisbon District, Portugal, 1099-023
        • Recruiting
        • Instituto Português de Oncologia de Lisboa Francisco Gentil ( Site 3103)
        • Contact:
          • Study Coordinator
          • Phone Number: 00351217229800
      • Lisbon, Lisbon District, Portugal, 1400-038
        • Recruiting
        • Champalimaud Foundation ( Site 3102)
        • Contact:
          • Study Coordinator
          • Phone Number: 00351210480200
    • Porto District
      • Vila Nova de Gaia, Porto District, Portugal, 4434-502
        • Recruiting
        • Unidade Local de Saude Gaia/Espinho - Hospital Eduardo Santos Silva ( Site 3107)
        • Contact:
          • Study Coordinator
          • Phone Number: 00351227865100
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 1864
        • Recruiting
        • Wits Clinical Research ( Site 1102)
        • Contact:
          • Study Coordinator
          • Phone Number: +27119836501
      • Pretoria, Gauteng, South Africa, 0181
        • Recruiting
        • Netcare Pretoria East Hospital-Alberts Cellular Therapy ( Site 1101)
        • Contact:
          • Study Coordinator
          • Phone Number: +27 12 993 2555
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7925
        • Recruiting
        • Groote Schuur Hospital-Clinical Haematology ( Site 1100)
        • Contact:
          • Study Coordinator
          • Phone Number: +27727689024
      • Kuilsriver, Western Cape, South Africa, 7580
        • Recruiting
        • Haemalife ( Site 1105)
        • Contact:
          • Study Coordinator
          • Phone Number: +27219006277
      • Plumstead, Western Cape, South Africa, 7800
        • Recruiting
        • Constantiaberg Haematology ( Site 1106)
        • Contact:
          • Study Coordinator
          • Phone Number: 0217992558
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1206)
        • Contact:
          • Study Coordinator
          • Phone Number: +34 934893806
      • Salamanca, Spain, 37007
        • Recruiting
        • Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 1201)
        • Contact:
          • Study Coordinator
          • Phone Number: 923291100 Ext. 55014
    • Barcelona
      • L'Hospitalet Del Llobregat, Barcelona, Spain, 08908
        • Recruiting
        • Institut Català d'Oncologia - L'Hospitalet-Haematology Department ( Site 1207)
        • Contact:
          • Study Coordinator
          • Phone Number: + 34 932607750
    • Catalonia
      • Barcelona, Catalonia, Spain, 08036
        • Recruiting
        • HOSPITAL CLÍNIC DE BARCELONA ( Site 1202)
        • Contact:
          • Study Coordinator
          • Phone Number: +34 619085109
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • Recruiting
        • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1209)
        • Contact:
          • Study Coordinator
          • Phone Number: +34 914521900
    • Madrid, Comunidad de
      • Majadahonda, Madrid, Comunidad de, Spain, 28220
        • Recruiting
        • HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 1208)
        • Contact:
          • Study Coordinator
          • Phone Number: +34 911917620
    • Santa Cruz De Tenerife
      • San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain, 38320
        • Recruiting
        • hospital universitario de canarias ( Site 1205)
        • Contact:
          • Study Coordinator
          • Phone Number: +34922678207
  • Sweden
    • Stockholm County
      • Stockholm, Stockholm County, Sweden, 171 64
        • Recruiting
        • Karolinska Universitetssjukhuset Solna ( Site 1302)
        • Contact:
          • Study Coordinator
          • Phone Number: +46812370000
  • Taiwan
      • Kaohsiung City, Taiwan, 833
        • Recruiting
        • Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 1702)
        • Contact:
          • Study Coordinator
          • Phone Number: +88677317123
      • Tainan, Taiwan, 704302
        • Recruiting
        • National Cheng Kung University Hospital ( Site 1700)
        • Contact:
          • Study Coordinator
          • Phone Number: +88662752037
      • Taipei, Taiwan, 10048
        • Recruiting
        • National Taiwan University Hospital ( Site 1701)
        • Contact:
          • Study Coordinator
          • Phone Number: +886972652039
      • Taoyuan, Taiwan, 33305
        • Recruiting
        • Chang Gung Medical Foundation-Linkou Branch ( Site 1703)
        • Contact:
          • Study Coordinator
          • Phone Number: +88633281200
  • Thailand
    • Bangkok
      • Bangkok, Bangkok, Thailand, 10700
        • Recruiting
        • Faculty of Medicine Siriraj Hospital-Division of Hematology, Department of Medicine ( Site 1801)
        • Contact:
          • Study Coordinator
          • Phone Number: +6624197767
      • Pathumwan, Bangkok, Thailand, 10330
        • Recruiting
        • Chulalongkorn University ( Site 1802)
        • Contact:
          • Study Coordinator
          • Phone Number: +6624197767
    • Changwat Phitsanulok
      • Muang, Changwat Phitsanulok, Thailand, 65000
        • Recruiting
        • Naresuan University Hospital ( Site 1804)
        • Contact:
          • Study Coordinator
          • Phone Number: +6655965777
    • Changwat Songkhla
      • Hat Yai, Changwat Songkhla, Thailand, 90110
        • Recruiting
        • Songklanagarind hospital ( Site 1803)
        • Contact:
          • Study Coordinator
          • Phone Number: 6674451735
    • Chiang Mai
      • Muang, Chiang Mai, Thailand, 50200
        • Recruiting
        • Maharaj Nakorn Chiang Mai Hospital ( Site 1800)
        • Contact:
          • Study Coordinator
          • Phone Number: 6653935488
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06100
        • Recruiting
        • Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 1401)
        • Contact:
          • Study Coordinator
          • Phone Number: +90312 310 33 33
      • Ankara, Turkey (Türkiye), 06800
        • Recruiting
        • Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1407)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 312 552 60 00
      • Antalya, Turkey (Türkiye), 7100
        • Recruiting
        • Antalya Egitim ve Arastırma Hastanesi ( Site 1409)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 242 2494400-4143
      • Edirne, Turkey (Türkiye), 22030
        • Recruiting
        • Trakya University Medical Faculty Hospital-Hematology ( Site 1403)
        • Contact:
          • Study Coordinator
          • Phone Number: +905438561362
      • Istanbul, Turkey (Türkiye), 34214
        • Recruiting
        • Mega Medipol ( Site 1412)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 5077078197
      • Istanbul, Turkey (Türkiye), 34381
        • Recruiting
        • Sisli Florence Nightingale Hastanesi ( Site 1411)
        • Contact:
          • Study Coordinator
          • Phone Number: +90444 04 36
      • Istanbul, Turkey (Türkiye), 34899
        • Completed
        • Marmara Universitesi Pendik Egitim Arastirma Hastanesi ( Site 1408)
      • Izmir, Turkey (Türkiye), 35100
        • Recruiting
        • Ege Universitesi Hastanesi ( Site 1404)
        • Contact:
          • Study Coordinator
          • Phone Number: +905325566128
      • Samsun, Turkey (Türkiye), 55280
        • Recruiting
        • Ondokuz Mays Üniversitesi ( Site 1410)
        • Contact:
          • Study Coordinator
          • Phone Number: +903624576041
  • United Kingdom
      • Barnet, United Kingdom, EN5 3DJ
        • Recruiting
        • Barnet Hospital ( Site 3005)
        • Contact:
          • Study Coordinator
          • Phone Number: 0208 216 4755
      • Leeds, United Kingdom, LS9 7TF
        • Recruiting
        • St James's University Hospital ( Site 3004)
        • Contact:
          • Study Coordinator
          • Phone Number: +441132432799
      • Nottingham, United Kingdom, NG5 1PB
        • Completed
        • City Hospital, Nottingham University Hospitals NHS Trust ( Site 3003)
    • Bristol, City of
      • Bristol, Bristol, City of, United Kingdom, BS10 5NB
        • Completed
        • Southmead Hospital ( Site 3010)
    • Lancashire
      • Lancaster, Lancashire, United Kingdom, LA1 4RP
        • Recruiting
        • Royal Lancaster Infirmary ( Site 3012)
        • Contact:
          • Study Coordinator
          • Phone Number: 01524 512128
    • London, City of
      • London, London, City of, United Kingdom, EC1A 7BE
        • Recruiting
        • St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3006)
        • Contact:
          • Study Coordinator
          • Phone Number: +442073777000
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LE
        • Recruiting
        • The Churchill Hospital ( Site 3007)
        • Contact:
          • Study Coordinator
          • Phone Number: 441865235886
    • South Gloucestershire
      • Bristol, South Gloucestershire, United Kingdom, BS32 4SY
        • Recruiting
        • GenesisCare - Bristol ( Site 3011)
        • Contact:
          • Study Coordinator
          • Phone Number: +441173421121
    • Suffolk
      • Newmarket, Suffolk, United Kingdom, CB8 7XN
        • Recruiting
        • GenesisCare - Cambridge ( Site 3001)
        • Contact:
          • Study Coordinator
          • Phone Number: 01223 907622
    • Windsor And Maidenhead
      • Windsor, Windsor And Maidenhead, United Kingdom, SL4 3HD
        • Recruiting
        • GenesisCare - Windsor ( Site 3002)
        • Contact:
          • Study Coordinator
          • Phone Number: 447989474250
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36604
        • Recruiting
        • USA Mitchell Cancer Institute ( Site 0014)
        • Contact:
          • Study Coordinator
          • Phone Number: 251-665-8000
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Recruiting
        • Banner MD Anderson Cancer Center ( Site 0059)
        • Contact:
          • Study Coordinator
          • Phone Number: 480-256-5490
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Banner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0051)
        • Contact:
          • Study Coordinator
          • Phone Number: 480-256-5490
      • Prescott, Arizona, United States, 86301
        • Completed
        • Arizona Oncology Associates - NAHOA ( Site 8007)
    • California
      • Berkeley, California, United States, 94704
        • Recruiting
        • Alta Bates Summit Medical Center ( Site 0004)
        • Contact:
          • Study Coordinator
          • Phone Number: 510-204-3428
      • La Jolla, California, United States, 92093-0698
        • Recruiting
        • Moores Cancer Center ( Site 0003)
        • Contact:
          • Study Coordinator
          • Phone Number: 858-534-5201
      • Pasadena, California, United States, 91105
        • Recruiting
        • Care Access - South Pasadena ( Site 0070)
        • Contact:
          • Study Coordinator
          • Phone Number: 626-556-9930
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Saint Joseph Hospital ( Site 0026)
        • Contact:
          • Study Coordinator
          • Phone Number: 303-403-6381
      • Golden, Colorado, United States, 80401
        • Recruiting
        • Lutheran Medical Center ( Site 0027)
        • Contact:
          • Study Coordinator
          • Phone Number: 303-403-6381
      • Grand Junction, Colorado, United States, 81501
        • Recruiting
        • Intermountain Health St. Mary's Regional Hospital ( Site 0025)
        • Contact:
          • Study Coordinator
          • Phone Number: 970-298-7638
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Recruiting
        • Eastern CT Hematology & Oncology Associates ( Site 0033)
        • Contact:
          • Study Coordinator
          • Phone Number: 860-886-8362
    • Florida
      • Clermont, Florida, United States, 34711
        • Recruiting
        • Clermont Oncology Center ( Site 0046)
        • Contact:
          • Study Coordinator
          • Phone Number: 386-538-3169
      • Fort Myers, Florida, United States, 33901
        • Recruiting
        • Florida Cancer Specialists - South ( Site 7001)
        • Contact:
          • Study Coordinator
          • Phone Number: 239-274-9930
      • West Palm Beach, Florida, United States, 33401
        • Recruiting
        • Florida Cancer Specialists - East ( Site 7002)
        • Contact:
          • Study Coordinator
          • Phone Number: 727-216-1143
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Recruiting
        • Parkview Research Center at Parkview Regional Medical Center ( Site 0002)
        • Contact:
          • Study Coordinator
          • Phone Number: 260-266-7100
    • Iowa
      • Waukee, Iowa, United States, 50263
        • Recruiting
        • University of Iowa Health Care. ( Site 0017)
        • Contact:
          • Study Coordinator
          • Phone Number: 319-356-1616
      • Waukee, Iowa, United States, 50263
        • Recruiting
        • University of Iowa Health Care. ( Site 0057)
        • Contact:
          • Study Coordinator
          • Phone Number: 319-356-1616
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Recruiting
        • Saint Elizabeth Healthcare ( Site 0041)
        • Contact:
          • Study Coordinator
          • Phone Number: 859-301-2000
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Corewell Health-Lemmon Holton Cancer Pavilion ( Site 0011)
        • Contact:
          • Study Coordinator
          • Phone Number: 616-267-7566
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55416
        • Recruiting
        • Regions Hospital ( Site 0042)
        • Contact:
          • Study Coordinator
          • Phone Number: 952-993-3252
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Recruiting
        • MidAmerica Cancer Care, LLC ( Site 0043)
        • Contact:
          • Study Coordinator
          • Phone Number: 816-974-5050
    • Montana
      • Billings, Montana, United States, 59102
        • Recruiting
        • Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0052)
        • Contact:
          • Study Coordinator
          • Phone Number: 406-238-6685
    • New Jersey
      • Florham Park, New Jersey, United States, 07932
        • Completed
        • Summit Medical Group Cancer Center ( Site 0007)
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0016)
        • Contact:
          • Study Coordinator
          • Phone Number: 551-996-3277
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • New York Oncology Hematology, P.C. ( Site 0069)
        • Contact:
          • Study Coordinator
          • Phone Number: 518-262-6696
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute ( Site 0023)
        • Contact:
          • Study Coordinator
          • Phone Number: 716-845-2300
      • Williamsville, New York, United States, 14221
        • Recruiting
        • RPCI Oncology, PC- Northtowns ( Site 0061)
        • Contact:
          • Study Coordinator
          • Phone Number: 716-634-3340
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Recruiting
        • Carolina Oncology Specialists, PA ( Site 0054)
        • Contact:
          • Study Coordinator
          • Phone Number: 704-342-1900
      • Goldsboro, North Carolina, United States, 27534
        • Recruiting
        • Southeastern Medical Oncology Center ( Site 0049)
        • Contact:
          • Study Coordinator
          • Phone Number: 919-587-9088
    • Pennsylvania
      • Broomall, Pennsylvania, United States, 19008
        • Recruiting
        • Consultants in Medical Oncology and Hematology (CMOH) ( Site 8002)
        • Contact:
          • Study Coordinator
          • Phone Number: 610-585-6287
      • York, Pennsylvania, United States, 17403
        • Recruiting
        • Cancer Care Associates Of York ( Site 0005)
        • Contact:
          • Study Coordinator
          • Phone Number: 717-741-9229
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Recruiting
        • Tennessee Oncology-Chattanooga ( Site 0045)
        • Contact:
          • Study Coordinator
          • Phone Number: 615-986-4350
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 0031)
        • Contact:
          • Study Coordinator
          • Phone Number: 615-986-4350
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Texas Oncology - Central/South Texas ( Site 8008)
        • Contact:
          • Study Coordinator
          • Phone Number: 512-421-4100
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • The Center for Cancer and Blood Disorders ( Site 0032)
        • Contact:
          • Study Coordinator
          • Phone Number: 817-759-7013
      • San Antonio, Texas, United States, 78217
        • Recruiting
        • Texas Oncology - San Antonio ( Site 8006)
        • Contact:
          • Study Coordinator
          • Phone Number: 210-419-2608
      • Tyler, Texas, United States, 75702
        • Recruiting
        • Texas Oncology - Northeast Texas ( Site 8012)
        • Contact:
          • Study Coordinator
          • Phone Number: 903-579-9800
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia Cancer Center ( Site 0040)
        • Contact:
          • Study Coordinator
          • Phone Number: 434-243-2649
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Inova Schar Cancer Institute ( Site 0015)
        • Contact:
          • Study Coordinator
          • Phone Number: 571-472-4724
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University (VCU) Medical Center ( Site 0030)
        • Contact:
          • Study Coordinator
          • Phone Number: 804-628-2072
    • Washington
      • Spokane, Washington, United States, 99208
        • Recruiting
        • Medical Oncology Associates, PS (dba Summit Cancer Centers) ( Site 0010)
        • Contact:
          • Study Coordinator
          • Phone Number: 509-462-2273
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University Hospital and UW Health Clinics ( Site 0006)
        • Contact:
          • Study Coordinator
          • Phone Number: 608-263-6400
      • Madison, Wisconsin, United States, 53715
        • Recruiting
        • SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical ( Site 0048)
        • Contact:
          • Study Coordinator
          • Phone Number: 608-410-2700

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nemtabrutinib
Participants will receive nemtabrutinib at specified dose until disease progression, unacceptable toxicity or until discontinuation criteria are met.
Drug: Nemtabrutinib
Administered orally
Other Names:
  • MK-1026
  • ARQ 531
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.
Drug: Ibrutinib
Administered orally
Drug: Acalabrutinib
Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) per Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as assessed by Blinded Independent Central Review (BICR)
Time Frame: Up to ~33 months
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.
Up to ~33 months
Progression-Free Survival (PFS) per iwCLL Criteria 2018 as assessed by BICR
Time Frame: Up to ~104 months
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.
Up to ~104 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to ~104 months
OS is defined as the time from randomization to death due to any cause.
Up to ~104 months
Duration of Response (DOR) per iwCLL Criteria 2018 as assessed by BICR
Time Frame: Up to ~104 months
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.
Up to ~104 months
Number of Participants Who Experience One or More Adverse Events (AEs)
Time Frame: Up to ~104 months
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.
Up to ~104 months
Number of Participants Who Discontinue Study Treatment Due to an AE
Time Frame: Up to ~104 months
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.
Up to ~104 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2023

Primary Completion (Estimated)

September 7, 2032

Study Completion (Estimated)

September 7, 2032

Study Registration Dates

First Submitted

November 13, 2023

First Submitted That Met QC Criteria

November 13, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1026-011
  • U1111-1281-7895 (Registry Identifier: UTN)
  • MK-1026-011 (Other Identifier: MSD)
  • BELLWAVE-011 (Other Identifier: MSD)
  • jRCT2031230697 (Registry Identifier: jRCT)
  • 2022-501697-19-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Lymphocytic Leukemia

Clinical Trials on Ibrutinib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe