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RECRUITING Phase 3 ClinicalTrials.gov

A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia

Sponsor: BeOne Medicines • ClinicalTrials.gov ID: NCT07277231

Registry updated: 2026-09-28
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Description

The purpose of this study is to investigate the efficacy and safety of fixed-duration sonrotoclax (also known as BGB-11417) plus zanubrutinib (also known as BGB-3111) (SZ) compared with fixed-duration of venetoclax plus acalabrutinib (AV) in participants with previously untreated chronic lymphocytic leukemia (CLL).

Interventions

  • Sonrotoclax (Drug)
    Administered orally.
  • Zanubrutinib (Drug)
    Administered orally.
  • Acalabrutinib (Drug)
    Administered orally.
  • Venetoclax (Drug)
    Administered orally.

Eligibility criteria

Inclusion Criteria: * Treatment-naïve (TN) adults with confirmed diagnosis of CLL which requires treatment * Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2 * Measurable disease by Computer Tomography/Magnetic Resonance Imaging * Adequate bone marrow and organ function Exclusion Criteria: * Previous systemic treatment for CLL * Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation * Known central nervous system involvement * History of confirmed progressive multifocal leukoencephalopathy (PML) * Uncontrolled hypertension or clinically significant cardiovascular disease Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Conditions

Chronic Lymphocytic Leukemia

Locations

  • City of Hope National Medical Center — Duarte, California, United States
  • Chao Family Comprehensive Cancer Center — Orange, California, United States
  • Stanford Cancer Institute — Palo Alto, California, United States
  • Rocky Mountain Cancer Centers (Williams) Usor — Aurora, Colorado, United States
  • Mayo Clinic Jacksonville — Jacksonville, Florida, United States
  • Mount Sinai Medical Center Braman Comprehensive Cancer Center — Miami, Florida, United States
  • Moffitt Cancer Center — Tampa, Florida, United States
  • Northwestern University — Chicago, Illinois, United States
  • Midwestern Regional Medical Center — Zion, Illinois, United States
  • Ochsner Clinic Foundation — New Orleans, Louisiana, United States
  • Dana Farber Cancer Institute — Boston, Massachusetts, United States
  • Mayo Clinic Rochester — Rochester, Minnesota, United States
  • University of Nebraska Medical Center — Omaha, Nebraska, United States
  • Columbia University Medical Center — New York, New York, United States
  • Atrium Health Levine Cancer Institute (Lci) — Charlotte, North Carolina, United States
  • Duke University Medical Center — Durham, North Carolina, United States
  • Oncology Associates of Oregon Willamette Valley Cancer Center — Eugene, Oregon, United States
  • Upmc Hillman Cancer Center(Univ of Pittsburgh) — Pittsburgh, Pennsylvania, United States
  • Texas Oncology Tyler — Tyler, Texas, United States
  • Huntsman Cancer Institute — Salt Lake City, Utah, United States
  • Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
  • Medical College of Wisconsin — Milwaukee, Wisconsin, United States
  • Blacktown Cancer and Haematology Centre — Blacktown, New South Wales, Australia
  • Concord Repatriation General Hospital — Concord, New South Wales, Australia
  • Genesiscare North Shore — St Leonards, New South Wales, Australia
  • Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
  • Monash Health — Clayton, Victoria, Australia
  • Austin Health — Heidelberg, Victoria, Australia
  • Cabrini Hospital Malvern — Malvern, Victoria, Australia
  • The Alfred Hospital — Melbourne, Victoria, Australia
  • Instituto Dor de Pesquisa E Ensino Distrito Federal — Brasília, Brazil
  • Centro Gaucho Integrado de Oncologia Hospital Mae de Deus — Porto Alegre, Brazil
  • Ensino E Terapia de Inovacao Clinica Amo Etica — Salvador, Brazil
  • Instituto Dor de Pesquisa E Ensino Sao Paulo — São Paulo, Brazil
  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein — São Paulo, Brazil
  • Bc Cancer Victoria — Victoria, British Columbia, Canada
  • Juravinski Cancer Centre — Hamilton, Ontario, Canada
  • Ciusss Nim Hscm — Montreal, Quebec, Canada
  • Jewish General Hospital — Montreal, Quebec, Canada
  • Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic) — Québec, Quebec, Canada
  • Ciusss de Lestrie Chus — Sherbrooke, Quebec, Canada
  • Peking Union Medical College Hospital — Beijing, Beijing Municipality, China
  • The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China
  • The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China
  • Zhujiang Hospital of Southern Medical University — Guangzhou, Guangdong, China
  • Sun Yat Sen University Cancer Center Huangpu Branch — Guangzhou, Guangdong, China
  • The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China
  • Guizhou Provincial Peoples Hospital — Guiyang, Guizhou, China
  • Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China
  • Henan Cancer Hospital — Zhengzhou, Henan, China
  • The Second Xiangya Hospital of Central South University — Changsha, Hunan, China
  • Jiangsu Province Hospital — Nanjing, Jiangsu, China
  • Affiliated Hospital of Nantong University — Nantong, Jiangsu, China
  • The Second Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China
  • The Second Affiliated Hospital of Xian Jiaotong University — Xi'an, Shaanxi, China
  • Shandong Provincial Hospital — Jinan, Shandong, China
  • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China
  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital — Chengdu, Sichuan, China
  • Institute of Hematology and Hospital of Blood Disease — Tianjin, Tianjin Municipality, China
  • First Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China
  • The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan — Hangzhou, Zhejiang, China
  • Fakultni Nemocnice Brno — Brno, Czechia
  • Fakultni Nemocnice Hradec Kralove — Hradec Králové, Czechia
  • Fakultni Nemocnice Olomouc — Olomouc, Czechia
  • Fakultni Nemocnice Ostrava — Ostrava, Czechia
  • Fakultni Nemocnice Plzen — PLZE, Czechia
  • Vseobecna Fakultni Nemocnice V Praze — Prague, Czechia
  • Centre de Lutte Contre Le Cancer Institut Bergonie — Bordeaux, France
  • Chu Clermont Ferrand Therapie Cellulaire and Hematolo — ClermontFerrand, France
  • Centre Hospitalier Le Mans — Le Mans, France
  • Hopital Claude Huriez Chu Lille — Lille, France
  • Centre Leon Berard — Lyon, France
  • Chu Montpellier Hopital Saint Eloi — Montpellier, France
  • Iuc Toulouse Oncopole — Toulouse, France
  • Donauisar Klinikum Deggendorf Klinik Fur Onkologie Und Hamatologie — Deggendorf, Germany
  • Centrum Fur Haematologie Und Onkologie Bethanien — Frankfurt am Main, Germany
  • Geho Munster — Münster, Germany
  • Klinikum St Elisabeth Straubing Gmbh Mvz Klinikum Straubing Gmbh — Straubing, Germany
  • Irccs Azienda Ospedaliero Universitaria Bologna — Bologna, Italy
  • Aou Careggi, Servizio Sanitario Toscana — Florence, Italy
  • Ospedale San Raffaele — Milan, Italy
  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda — Milan, Italy
  • Azienda Ospedaliera Di Padova — Padova, Italy
  • Fondazione Policlinico Universitario Agostino Gemelli — Roma, Italy
  • Flevoziekenhuis — Almere Stad, Netherlands
  • Albert Schweitzer Ziekenhuis — Dordrecht, Netherlands
  • Hagaziekenhuis — Sgravenhage, Netherlands
  • North Shore Hospital — Auckland, New Zealand
  • Auckland City Hospital — Auckland, New Zealand
  • Health New Zealand Canterbury — Christchurch, New Zealand
  • Dunedin Hospital — Dunedin, New Zealand
  • Wellington Regional Hospital (Ccdhb) — Wellington, New Zealand
  • Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny — Brzozów, Poland
  • Pratia Onkologia Katowice — Katowice, Poland
  • Pratia McM Krakow — Krakow, Poland
  • Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie — Lublin, Poland
  • Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu — Wroclaw, Poland
  • Coltea Clinical Hospital — Bucharest, Romania
  • Institutul Clinic Fundeni — Bucureti, Romania
  • Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca — ClujNapoca, Romania
  • Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea
  • The Catholic University of Korea, Seoul St Marys Hospital — SeochoGu, Seoul Teugbyeolsi, South Korea
  • Severance Hospital Yonsei University Health System — SeodaemunGu, Seoul Teugbyeolsi, South Korea
  • Seoul National University Hospital — Seoul, Seoul Teugbyeolsi, South Korea
  • Asan Medical Center — SongpaGu, Seoul Teugbyeolsi, South Korea
  • Hospital Universitario Virgen de Las Nieves — Granada, Spain
  • Hospital Universitario 12 de Octubre — Madrid, Spain
  • Hospital Universitario Puerta de Hierro Majadahonda — Majadahonda, Spain
  • Hospital Clinico Universitario Virgen de La Arrixaca — Murcia, Spain
  • Karolinska Universitetssjukhuset Solna — Stockholm, Sweden
  • Queen Elizabeth Hospital — Birmingham, United Kingdom
  • University Hospitals Dorset Royal Bournemouth Hospital — Bournemouth, United Kingdom
  • St Jamess University Hospital — Leeds, United Kingdom
  • Kings College Hospital — London, United Kingdom
  • Norfolk and Norwich University Hospitals Nhs Foundation Trust — Norwich, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record