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
Start Date
4/10/2025
Completion Date
2/14/2030
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).
Detailed Description
Chronic lymphocytic leukemia is a type of blood cancer that affects people around the world. People with CLL suffer from enlarged lymph nodes, spleen, or liver, or have symptoms like night sweats, weight loss and fever. They have shorter life expectancy compared to healthy people. There is an urgent need for new treatment to prolong life and control disease-related symptoms. In this study, participants with relapsed/refractory (R/R) CLL who were previously exposed to a BTKi and a BCL2i will receive BGB-16673 or the investigator's choice of idelalisib plus rituximab (for CLL only) or bendamustine plus rituximab or venetoclax plus rituximab retreatment. The main purpose of this study is to compare the length of time that participants live without their CLL or SLL worsening between those participants who receive BGB-16673 versus the investigator's choice of treatment (idelalisib plus rituximab or bendamustine plus rituximab, or venetoclax plus rituximab). Approximately 250 participants will be included in this study around the world. Participants will be randomly allocated to receive either BGB-16673 or the investigator's choice of treatment. "Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website."
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
BGB-16673
Bendamustine
Idelalisib
Rituximab
Venetoclax
Conditions
Locations
St Bernards Medical Center
Jonesboro, Arkansas 72401
United States
UCLA Department of Medicine Hematologyoncology
Los Angeles, California 90095-3075
United States
Pih Health Whittier Hospital
Whittier, California 90602
United States
Rocky Mountain Cancer Centers (Williams) Usor
Aurora, Colorado 80012-5405
United States
Florida Oncology and Hematology
Fort Myers, Florida 33912
United States
Baptist Md Anderson Cancer Center
Jacksonville, Florida 32207-8432
United States
Cleveland Clinic Florida
Weston, Florida 33331-3609
United States
Emory University Winship Cancer Institute
Atlanta, Georgia 30322-1013
United States
Northside Cancer Center
Atlanta, Georgia 30342
United States
Our Lady of the Lake Hospital
Baton Rouge, Louisiana 70808-4365
United States
American Oncology Partners of Maryland Pa
Bethesda, Maryland 20817-7847
United States
Oncology Hematology Associates
Springfield, Missouri 65807-5288
United States
Oncology Hematology West, Pc Dba Nebraska Cancer Specialists
Omaha, Nebraska 68130-2042
United States
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York 10065-6800
United States
New York Cancer and Blood Specialists
Shirley, New York 11967
United States
Optum Medical Care, Pc
Westbury, New York 11590-5119
United States
University Hospitals
Cleveland, Ohio 44106-1716
United States
Dayton Physician Network
Dayton, Ohio 45415
United States
Oncology Associates of Oregon Willamette Valley Cancer Center
Eugene, Oregon 97401
United States
West Penn Hospital
Pittsburgh, Pennsylvania 15224
United States
Cancer Care Associates of York
York, Pennsylvania 17403-5049
United States
Texas Oncology Tyler
Tyler, Texas 75702-7522
United States
Hospital Aleman
CABA, 1425
Argentina
CEMIC
Caba, C1431
Argentina
FUNDALEU
Caba, CP1114
Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires, 1413
Argentina
Instituto Alexander Fleming (Iaf)
Ciudad Autonoma Buenos Aires, 1426
Argentina
Cice 9 de Julio Sanatorio 9 de Julio
San Miguel de Tucumán, 4000
Argentina
Concord Repatriation General Hospital
Concord, New South Wales NSW 2139
Australia
Gosford Hospital
Gosford, New South Wales NSW 2250
Australia
Port Macquarie Base Hospital
Port Macquarie, New South Wales NSW 2444
Australia
Prince of Wales Hospital
Randwick, New South Wales NSW 2031
Australia
Toowoomba Hospital
Toowoomba, Queensland QLD 4350
Australia
Flinders Medical Centre
Bedford PK, South Australia SA 5042
Australia
The Alfred Hospital
Melbourne, Victoria VIC 3004
Australia
Perth Blood Institute
West Perth, Western Australia WA 6005
Australia
CETUS
Belo Horizonte, 30110-022
Brazil
Hospital Sirio Libanes Brasilia
Brasília, 70200-730
Brazil
Hospital Erasto Gaertner
Curitiba, 81520-060
Brazil
Centro de Ensino E Pesquisa Em Oncologia de Santa Catarina (Cepen)
Florianópolis, 88020-210
Brazil
Instituto Joinvilense de Hematologia E Oncologia
Joinville, 89201-260
Brazil
Complexo Hospitalar de Niteroi
Niterói, 24020-096
Brazil
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, 90110-270
Brazil
Hospital Santa Joana Recife
Recife, 52011-906
Brazil
Hospital Sao Lucas Dasa Oncologia
Rio de Janeiro, 22061-080
Brazil
Oncoclinicas Rio de Janeiro Sa
Rio de Janeiro, 22250-040
Brazil
Hospital Sao Rafael (Rede Dor)
Salvador, 41253-190
Brazil
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo, 01401-004
Brazil
Instituto Brasileiro de Controle Do Cancer
São Paulo, 04014-002
Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, 05652-900
Brazil
Hospital Santa Rita de Cassia Afecc
Vitória, 29043-260
Brazil
London Health Sciences Centre
London, Ontario N6A 5W9
Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario K1H 8L6
Canada
Centre Integre de Sante Et de Services Sociaux de La Monteregie Centre
Greenfield Park, Quebec J4V 2H1
Canada
Jewish General Hospital
Montreal, Quebec QC H3t 1E2
Canada
Unite de Recherche Clinique Du Cisss Des Laurentides
SaintJerome, Quebec J7Z 5T3
Canada
Fakultni Nemocnice Brno
Brno, 625 00
Czechia
Fakultni Nemocnice Hradec Kralove
Hradec Králové, 500 03
Czechia
Fakultni Nemocnice Ostrava
Ostrava, 708 00
Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, 10000
Czechia
Universitatsklinikum Augsburg
Augsburg, 86156
Germany
Praxis Am Volkspark
Berlin, 10715
Germany
Klinikum Chemnitz Ggmbh
Chemnitz, 09116
Germany
Universitatsklinikum Essen (Aor)
Essen, 45122
Germany
Centrum Fur Haematologie Und Onkologie Bethanien
Frankfurt am Main, 60389
Germany
Universitatsklinikum Freiburg I Br Klinik Fur Innere Medizin I
Freiburg im Breisgau, 79106
Germany
Universitatsklinikum Hamburg Eppendorf
Hamburg, 20251
Germany
Universitatsklinikum Heidelberg
Heidelberg, 69120
Germany
Saarland University Medical Center
Homburg, 66421
Germany
Invo Institut Fur Versorgungsforschung in Der Onkologie
Koblenz, 56068
Germany
Universitaetsklinikum Leipzig Aor
Leipzig, 04103
Germany
Universitatsklinikum Munster Medizinische Klinik A
Münster, 48149
Germany
Irccs Istituto Tumori Giovanni Paolo Ii
Bari, 70124
Italy
Aou Careggi, Servizio Sanitario Toscana
Florence, 50134
Italy
Fondazione Irccs Ca Granda Ospedale Maggiore Policlinico
Milan, 20122
Italy
Ospedale San Raffaele
Milan, 20132
Italy
Azienda Ospedaliera Universitaria Federico Ii
Naples, 80131
Italy
Aou Maggiore Della Carita
Novara, 28100
Italy
Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi
Pavia, 27100
Italy
Ospedale Santa Maria Della Misericordia
Perugia, 6129
Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168
Italy
Aichi Cancer Center Hospital Clinical Oncology
Nagoya, Aichi-ken 464-8681
Japan
Nho Shikoku Cancer Center
Matsuyama, Ehime 791-0280
Japan
Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
Hiroshima, Hiroshima 730-8619
Japan
Aiiku Hospital
Sapporo, Hokkaido 064-0804
Japan
Hyogo Prefectural Amagasaki General Medical Center
AmagasakiCity, Hyōgo 660-8550
Japan
Kagoshima University Hospital
Kagoshima, Kagoshima-ken 890-8520
Japan
University Hospital, Kyoto Prefectural Univ of Medicine
KyotoShi, Kyoto 602-8566
Japan
Tohoku University Hospital
Sendai, Miyagi 980-8574
Japan
Niigata University Medical and Dental Hospital
Niigata, Niigata 951-8520
Japan
Kurashiki Central Hospital
Kurashikishi, Okayama-ken 710-8602
Japan
Kansai Medical University Hospital
Hirakata, Osaka 573-1191
Japan
Kindai University Hospital
Sakai, Osaka 590-0197
Japan
Saitama Medical Center
Kawagoeshi, Saitama 350-8550
Japan
Tokyo Metropolitan Komagome Hospital
Bunkyoku, Tokyo 113-8677
Japan
Ntt Medical Center Tokyo
Shinagawaku, Tokyo 141-0022
Japan
Kumamoto University Hospital
Kumamoto, 860-8556
Japan
National Hospital Organization Okayama Medical Center
Okayama, 701-1192
Japan
Osaka Metropolitan University Hospital
Osaka, 545-8586
Japan
Amsterdam Umc Vu Mc
Amsterdam, 1081 HV
Netherlands
Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny
Brzozów, 36-200
Poland
Pratia Onkologia Katowice
Katowice, 40-519
Poland
Pratia McM Krakow
Krakow, 30-727
Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
Lodz, 93-513
Poland
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Lublin, 20-090
Poland
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
Wroclaw, 50-367
Poland
Dong A University Hospital
Seogu, Busan Gwang'yeogsi 49201
South Korea
Kyungpook National University Hospital
Junggu, Daegu Gwang'yeogsi 41944
South Korea
National Cancer Center (Korea)
IlsandongGu GoyangSi, Gyeonggi-do 10408
South Korea
Chonnam National University Hwasun Hospital
HwasunGun, Jeollanam-do 58128
South Korea
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi 06351
South Korea
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi 06591
South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi 03080
South Korea
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara, 06200
Turkey (Türkiye)
Gazi University
Ankara, 6500
Turkey (Türkiye)
Dokuz Eylul University
Balçova, 35330
Turkey (Türkiye)
Antalya Memorial Hospital
Dokuma, 07025
Turkey (Türkiye)
Sakarya Training and Research Hospital
Sakarya, 54100
Turkey (Türkiye)
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN
United Kingdom
Birmingham Heartlands Hospital
Birmingham, B9 5SS
United Kingdom
The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
Bournemouth, BH7 7DW
United Kingdom
University College Hospital
London, NW1 2PG
United Kingdom
Royal Marsden Hospital
London, SW3 6JJ
United Kingdom
Southampton General Hospital
Southampton, SO16 6YD
United Kingdom