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
CaDAnCe-302
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
2 other identifiers
interventional
250
14 countries
115
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2025
Longer than P75 for phase_3
115 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2025
CompletedFirst Posted
Study publicly available on registry
February 26, 2025
CompletedStudy Start
First participant enrolled
April 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 14, 2030
April 22, 2026
April 1, 2026
3.1 years
February 21, 2025
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS) by Independent Review Committee (IRC)
PFS is defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by IRC using modified 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for participants with chronic lymphocytic leukemia (CLL) and Lugano classification for participants with small lymphocytic lymphoma (SLL).
Approximately 36 Months
Secondary Outcomes (10)
Overall Survival (OS)
Approximately 36 Months
Progression-Free Survival (PFS) in Participants with Prior Exposure to Noncovalent Bruton Tyrosine Kinase Inhibitor(s) (ncBTKi) by IRC
Approximately 36 Months
PFS by the Investigator Assessment
Approximately 36 Months
Overall Response Rate (ORR) by IRC and Investigator Assessment
Approximately 36 Months
Rate of Partial Response with Lymphocytosis (PR-L) or Higher Determined by IRC and by Investigator Assessment
Approximately 36 Months
- +5 more secondary outcomes
Study Arms (2)
Arm A: BGB-16673 monotherapy
EXPERIMENTALParticipants will receive BGB-16673 once daily until any of the treatment discontinuation criteria are met
Arm B: Investigator's Choice
ACTIVE COMPARATORParticipants will receive investigator's choice of idelalisib plus rituximab for CLL only or bendamustine plus rituximab, or venetoclax plus rituximab retreatment.
Interventions
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.
- Previously received treatment for CLL/SLL with both a BTKi and a BCL2i.
- Participants with SLL must have measurable disease by computer tomography (CT)/magnetic resonance imaging (MRI)
- Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
- Adequate liver function
- Adequate blood clotting function
You may not qualify if:
- Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
- Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 months
- Known central nervous system involvement
- Prior exposure to any BTK protein degraders
- Active fungal, bacterial and/or viral infection requiring parenteral systemic therapy
- Clinically significant cardiovascular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeOne Medicineslead
Study Sites (115)
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
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
Clinical Research Alliance, Inc
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
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
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
Toowoomba Hospital
Toowoomba, Queensland, QLD 4350, 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 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
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
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
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
BeOne Medicines
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2025
First Posted
February 26, 2025
Study Start
April 10, 2025
Primary Completion (Estimated)
May 15, 2028
Study Completion (Estimated)
February 14, 2030
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
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