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A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors
Sponsor: BeOne Medicines
Summary
The purpose of this study is to investigate the efficacy and safety of BGB-16673 compared with investigator's choice (idelalisib plus rituximab \[for CLL only\] or bendamustine plus rituximab or venetoclax plus rituximab retreatment) in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).
Official title: A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab or Venetoclax Plus Rituximab Retreatment) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both BTK and BCL2 Inhibitors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2025-04-10
Completion Date
2030-02-14
Last Updated
2026-03-19
Healthy Volunteers
No
Conditions
Interventions
BGB-16673
Administered orally
Bendamustine
Administered intravenously
Idelalisib
Administered orally
Rituximab
Administered intravenously
Venetoclax
Administered orally
Locations (112)
St Bernards Medical Center
Jonesboro, Arkansas, United States
UCLA Department of Medicine Hematologyoncology
Los Angeles, California, United States
Pih Health Whittier Hospital
Whittier, California, United States
Rocky Mountain Cancer Centers (Williams) Usor
Aurora, Colorado, United States
Florida Oncology and Hematology
Fort Myers, Florida, United States
Baptist Md Anderson Cancer Center
Jacksonville, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Emory University Winship Cancer Institute
Atlanta, Georgia, United States
Our Lady of the Lake Hospital
Baton Rouge, Louisiana, United States
American Oncology Partners of Maryland Pa
Bethesda, Maryland, United States
Oncology Hematology Associates
Springfield, Missouri, United States
Oncology Hematology West, Pc Dba Nebraska Cancer Specialists
Omaha, Nebraska, United States
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, United States
Clinical Research Alliance, Inc
Westbury, New York, United States
University Hospitals
Cleveland, Ohio, United States
Dayton Physician Network
Dayton, Ohio, United States
Oncology Associates of Oregon Willamette Valley Cancer Center
Eugene, Oregon, United States
West Penn Hospital
Pittsburgh, Pennsylvania, United States
Cancer Care Associates of York
York, Pennsylvania, United States
Texas Oncology Tyler
Tyler, Texas, United States
FUNDALEU
Caba, Argentina
Instituto Alexander Fleming (Iaf)
Ciudad Autonoma Buenos Aires, Argentina
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Gosford Hospital
Gosford, New South Wales, Australia
Port Macquarie Base Hospital
Port Macquarie, New South Wales, Australia
Toowoomba Hospital
Toowoomba, Queensland, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Perth Blood Institute
West Perth, Western Australia, Australia
CETUS
Belo Horizonte, Brazil
Hospital Sirio Libanes Brasilia
Brasília, Brazil
Hospital Erasto Gaertner
Curitiba, Brazil
Centro de Ensino E Pesquisa Em Oncologia de Santa Catarina (Cepen)
Florianópolis, Brazil
Instituto Joinvilense de Hematologia E Oncologia
Joinville, Brazil
Complexo Hospitalar de Niteroi
Niterói, Brazil
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, Brazil
Hospital Sao Lucas Dasa Oncologia
Rio de Janeiro, Brazil
Oncoclinicas Rio de Janeiro Sa
Rio de Janeiro, Brazil
Hospital Sao Rafael (Rede Dor)
Salvador, Brazil
Instituto Brasileiro de Controle Do Cancer
São Paulo, Brazil
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, Brazil
Hospital Santa Rita de Cassia Afecc
Vitória, Brazil
London Health Sciences Centre
London, Ontario, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Centre Integre de Sante Et de Services Sociaux de La Monteregie Centre
Greenfield Park, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Fakultni Nemocnice Brno
Brno, Czechia
Fakultni Nemocnice Hradec Kralove
Hradec Králové, Czechia
Fakultni Nemocnice Ostrava
Ostrava, Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, Czechia
Universitatsklinikum Augsburg
Augsburg, Germany
Praxis Am Volkspark
Berlin, Germany
Klinikum Chemnitz Ggmbh
Chemnitz, Germany
Universitatsklinikum Essen (Aor)
Essen, Germany
Centrum Fur Haematologie Und Onkologie Bethanien
Frankfurt am Main, Germany
Universitatsklinikum Hamburg Eppendorf
Hamburg, Germany
Universitatsklinikum Heidelberg
Heidelberg, Germany
Saarland University Medical Center
Homburg, Germany
Invo Institut Fur Versorgungsforschung in Der Onkologie
Koblenz, Germany
Universitaetsklinikum Leipzig Aor
Leipzig, Germany
Universitatsklinikum Munster Medizinische Klinik A
Münster, Germany
Irccs Istituto Tumori Giovanni Paolo Ii
Bari, Italy
Aou Careggi, Servizio Sanitario Toscana
Florence, Italy
Fondazione Irccs Ca Granda Ospedale Maggiore Policlinico
Milan, Italy
Ospedale San Raffaele
Milan, Italy
Azienda Ospedaliera Universitaria Federico Ii
Naples, Italy
Aou Maggiore Della Carita
Novara, Italy
Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi
Pavia, Italy
Ospedale Santa Maria Della Misericordia
Perugia, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, Italy
Aichi Cancer Center Hospital Clinical Oncology
Nagoya, Aichi-ken, Japan
Nho Shikoku Cancer Center
Matsuyama, Ehime, Japan
Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
Hiroshima, Hiroshima, Japan
Aiiku Hospital
Sapporo, Hokkaido, Japan
Hyogo Prefectural Amagasaki General Medical Center
AmagasakiCity, Hyōgo, Japan
Kagoshima University Hospital
Kagoshima, Kagoshima-ken, Japan
University Hospital, Kyoto Prefectural Univ of Medicine
KyotoShi, Kyoto, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Niigata University Medical and Dental Hospital
Niigata, Niigata, Japan
Kurashiki Central Hospital
Kurashikishi, Okayama-ken, Japan
Kansai Medical University Hospital
Hirakata, Osaka, Japan
Kindai University Hospital
Sakai, Osaka, Japan
Saitama Medical Center
Kawagoeshi, Saitama, Japan
Ntt Medical Center Tokyo
Shinagawaku, Tokyo, Japan
Kumamoto University Hospital
Kumamoto, Japan
National Hospital Organization Okayama Medical Center
Okayama, Japan
Osaka Metropolitan University Hospital
Osaka, Japan
Amsterdam Umc Vu Mc
Amsterdam, Netherlands
Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny
Brzozów, Poland
Pratia Onkologia Katowice
Katowice, Poland
Pratia McM Krakow
Krakow, Poland
Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
Lodz, Poland
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Lublin, Poland
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
Wroclaw, Poland
Dong A University Hospital
Seogu, Busan Gwang'yeogsi, South Korea
Kyungpook National University Hospital
Junggu, Daegu Gwang'yeogsi, South Korea
National Cancer Center (Korea)
IlsandongGu GoyangSi, Gyeonggi-do, South Korea
Chonnam National University Hwasun Hospital
HwasunGun, Jeollanam-do, South Korea
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara, Turkey (Türkiye)
Gazi University
Ankara, Turkey (Türkiye)
Dokuz Eylul University
Balçova, Turkey (Türkiye)
Antalya Memorial Hospital
Dokuma, Turkey (Türkiye)
Sakarya Training and Research Hospital
Sakarya, Turkey (Türkiye)
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
Birmingham Heartlands Hospital
Birmingham, United Kingdom
The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
Bournemouth, United Kingdom
University College Hospital
London, United Kingdom
Royal Marsden Hospital
London, United Kingdom
Southampton General Hospital
Southampton, United Kingdom