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)
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.
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Trialsites@msd.com1-888-577-8839
Mobile, Alabama 36604, United States
251-665-8000
Phoenix, Arizona 85006, United States
Berkeley, California 94704, United States
Grand Junction, Colorado 81501, United States
Norwich, Connecticut 06360, United States
Boca Raton, Florida 33486, United States
West Palm Beach, Florida 33401, United States
Fort Wayne, Indiana 46845, United States
Grand Rapids, Michigan 49503, United States
Billings, Montana 59102, United States
Florham Park, New Jersey 07932, United States
Hackensack, New Jersey 07601, United States
Charlotte, North Carolina 28207, United States
Goldsboro, North Carolina 27534, United States
Broomall, Pennsylvania 19008, United States
Nashville, Tennessee 37203, United States
Fort Worth, Texas 76104, United States
Charlottesville, Virginia 22903, United States
Richmond, Virginia 23298, United States
Spokane, Washington 99208, United States
Madison, Wisconsin 53715, United States
Madison, Wisconsin 53792, United States
Rimouski, Quebec G5L 5T1, Canada
Santiago, Region M. de Santiago 7650568, Chile
Beijing, Beijing Municipality 100191, China
Chongqing, Chongqing Municipality 400030, China
Guangzhou, Guangdong 510515, China
Nanning, Guangxi 530200, China
Guiyang, Guizhou 550004, China
Wuhan, Hubei 430000, China
Wuhan, Hubei 430058, China
Changsha, Hunan 410011, China
Suzhou, Jiangsu 215000, China
Xuzhou, Jiangsu 221006, China
Nanchang, Jiangxi 330006, China
Changchun, Jilin 130021, China
Chengdu, Sichuan 610041, China
Tianjin, Tianjin Municipality 300060, China
Tianjin, Tianjin Municipality 301617, China
Ürümqi, Xinjiang 830000, China
Hangzhou, Zhejiang 310003, China
Valledupar, Cesar Department 200001, Colombia
Cali, Valle del Cauca Department 760032, Colombia
Hradec Králové, 500 05, Czechia
Prague, 128 08, Czechia
Roskilde, Region Sjælland 4000, Denmark
Odense C, Region Syddanmark 5000, Denmark
Koblenz, Rhineland-Palatinate 56068, Germany
Alexandroupoli, East Macedonia and Thrace 681 00, Greece
Haifa, 3109601, Israel
Kobe, Hyōgo 650-0047, Japan
Koto, Tokyo 135-8550, Japan
Hiroshima, 730-8619, Japan
Lembah Pantai, Kuala Lumpur 59100, Malaysia
+60479492351
Mexico City, Mexico City 03100, Mexico
Lørenskog, Akershus 1474, Norway
+4767 96 00 00
Oslo, 0372, Norway
Lublin, Lublin Voivodeship 20-081, Poland
Warsaw, Masovian Voivodeship 02-781, Poland
Gdansk, Pomeranian Voivodeship 80-214, Poland
Słupsk, Pomeranian Voivodeship 76-200, Poland
Gliwice, Silesian Voivodeship 44-102, Poland
Olsztyn, Warmian-Masurian Voivodeship 10-228, Poland
Lisbon, Lisbon District 1099-023, Portugal
Vila Nova de Gaia, Porto District 4434-502, Portugal
Lisbon, 1449-005, Portugal
Lisbon, 1649-035, Portugal
Porto, 4200-072, Portugal
Pretoria, Gauteng 0181, South Africa
Cape Town, Western Cape 7925, South Africa
Kuilsriver, Western Cape 7580, South Africa
+27219006277
L'Hospitalet Del Llobregat, Barcelona 08908, Spain
+ 34 932607750
Pozuelo de Alarcón, Madrid 28223, Spain
Majadahonda, Madrid, Comunidad de 28220, Spain
San Cristóbal de La Laguna, Santa Cruz De Tenerife 38320, Spain
Barcelona, 08035, Spain
Salamanca, 37007, Spain
Stockholm, Stockholm County 171 64, Sweden
Kaohsiung City, 833, Taiwan
Bangkok, Bangkok 10700, Thailand
Pathumwan, Bangkok 10330, Thailand
+6624197767
Muang, Changwat Phitsanulok 65000, Thailand
+6655965777
Muang, Chiang Mai 50200, Thailand
6653935488
Ankara, 06100, Turkey (Türkiye)
Ankara, 06800, Turkey (Türkiye)
Edirne, 22030, Turkey (Türkiye)
Istanbul, 34899, Turkey (Türkiye)
London, London, City of EC1A 7BE, United Kingdom
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