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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
NCT06846671 · BeOne Medicines
In plain English
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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
About this study
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
Inclusion Criteria:
1. Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.
2. Previously received treatment for CLL/SLL with both a BTKi and a BCL2i.
3. Participants with SLL must have measurable disease by computer tomography (CT)/magnetic resonance imaging (MRI)
4. Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
5. Adequate liver function
6. Adequate blood clotting function
Exclusion Criteria:
1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
2. Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 months
3. Known central nervous system involvement
4. Prior exposure to any BTK protein degraders
5. Active fungal, bacterial and/or viral infection requiring parenteral systemic therapy
6. Clinically significant cardiovascular disease
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study design
Enrollment target: 250 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-04-10
Estimated completion: 2030-02-14
Last updated: 2026-04-16
Interventions
Drug: BGB-16673Drug: BendamustineDrug: IdelalisibDrug: RituximabDrug: Venetoclax
Primary outcomes
- • Progression-Free Survival (PFS) by Independent Review Committee (IRC) (Approximately 36 Months)
Sponsor
BeOne Medicines · industry
Contacts & investigators
ContactStudy Director · contact · clinicaltrials@beonemed.com · 1.877.828.5568
InvestigatorStudy Director · study_director, BeOne Medicines
All locations (114)
St Bernards Medical CenterRecruiting
Jonesboro, Arkansas, United States
UCLA Department of Medicine HematologyoncologyRecruiting
Los Angeles, California, United States
Pih Health Whittier HospitalRecruiting
Whittier, California, United States
Rocky Mountain Cancer Centers (Williams) UsorRecruiting
Aurora, Colorado, United States
Florida Oncology and HematologyRecruiting
Fort Myers, Florida, United States
Baptist Md Anderson Cancer CenterRecruiting
Jacksonville, Florida, United States
Cleveland Clinic FloridaRecruiting
Weston, Florida, United States
Emory University Winship Cancer InstituteRecruiting
Atlanta, Georgia, United States
Our Lady of the Lake HospitalRecruiting
Baton Rouge, Louisiana, United States
American Oncology Partners of Maryland PaRecruiting
Bethesda, Maryland, United States
Oncology Hematology AssociatesRecruiting
Springfield, Missouri, United States
Oncology Hematology West, Pc Dba Nebraska Cancer SpecialistsRecruiting
Omaha, Nebraska, United States
Memorial Sloan Kettering Cancer Center MskccRecruiting
New York, New York, United States
Clinical Research Alliance, IncRecruiting
Westbury, New York, United States
University HospitalsRecruiting
Cleveland, Ohio, United States
Dayton Physician NetworkRecruiting
Dayton, Ohio, United States
Oncology Associates of Oregon Willamette Valley Cancer CenterRecruiting
Eugene, Oregon, United States
West Penn HospitalRecruiting
Pittsburgh, Pennsylvania, United States
Cancer Care Associates of YorkRecruiting
York, Pennsylvania, United States
Texas Oncology TylerRecruiting
Tyler, Texas, United States
FUNDALEURecruiting
Caba, Argentina
Hospital Italiano de Buenos AiresRecruiting
Ciudad Autonoma Buenos Aires, Argentina
Instituto Alexander Fleming (Iaf)Recruiting
Ciudad Autonoma Buenos Aires, Argentina
Concord Repatriation General HospitalRecruiting
Concord, New South Wales, Australia
Gosford HospitalRecruiting
Gosford, New South Wales, Australia
Port Macquarie Base HospitalRecruiting
Port Macquarie, New South Wales, Australia
Toowoomba HospitalRecruiting
Toowoomba, Queensland, Australia
The Alfred HospitalRecruiting
Melbourne, Victoria, Australia
Perth Blood InstituteRecruiting
West Perth, Western Australia, Australia
CETUSRecruiting
Belo Horizonte, Brazil
Hospital Sirio Libanes BrasiliaRecruiting
Brasília, Brazil
Hospital Erasto GaertnerRecruiting
Curitiba, Brazil
Centro de Ensino E Pesquisa Em Oncologia de Santa Catarina (Cepen)Recruiting
Florianópolis, Brazil
Instituto Joinvilense de Hematologia E OncologiaRecruiting
Joinville, Brazil
Complexo Hospitalar de NiteroiRecruiting
Niterói, Brazil
Centro Gaucho Integrado de Oncologia Hospital Mae de DeusRecruiting
Porto Alegre, Brazil
Hospital Sao Lucas Dasa OncologiaRecruiting
Rio de Janeiro, Brazil
Oncoclinicas Rio de Janeiro SaRecruiting
Rio de Janeiro, Brazil
Hospital Sao Rafael (Rede Dor)Recruiting
Salvador, Brazil
Instituto Brasileiro de Controle Do CancerRecruiting
São Paulo, Brazil
Instituto Dor de Pesquisa E Ensino Sao PauloRecruiting
São Paulo, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert EinsteinRecruiting
São Paulo, Brazil
Hospital Santa Rita de Cassia AfeccRecruiting
Vitória, Brazil
London Health Sciences CentreRecruiting
London, Ontario, Canada
The Ottawa Hospital Cancer CentreRecruiting
Ottawa, Ontario, Canada
Centre Integre de Sante Et de Services Sociaux de La Monteregie CentreRecruiting
Greenfield Park, Quebec, Canada
Jewish General HospitalRecruiting
Montreal, Quebec, Canada
Fakultni Nemocnice BrnoRecruiting
Brno, Czechia
Fakultni Nemocnice Hradec KraloveRecruiting
Hradec Králové, Czechia
Fakultni Nemocnice OstravaRecruiting
Ostrava, Czechia
Vseobecna Fakultni Nemocnice V PrazeRecruiting
Prague, Czechia
Universitatsklinikum AugsburgRecruiting
Augsburg, Germany
Praxis Am VolksparkRecruiting
Berlin, Germany
Klinikum Chemnitz GgmbhRecruiting
Chemnitz, Germany
Universitatsklinikum Essen (Aor)Recruiting
Essen, Germany
Centrum Fur Haematologie Und Onkologie BethanienRecruiting
Frankfurt am Main, Germany
Universitatsklinikum Freiburg I Br Klinik Fur Innere Medizin IRecruiting
Freiburg im Breisgau, Germany
Universitatsklinikum Hamburg EppendorfRecruiting
Hamburg, Germany
Universitatsklinikum HeidelbergRecruiting
Heidelberg, Germany
Saarland University Medical CenterRecruiting
Homburg, Germany
Invo Institut Fur Versorgungsforschung in Der OnkologieRecruiting
Koblenz, Germany
Universitaetsklinikum Leipzig AorRecruiting
Leipzig, Germany
Universitatsklinikum Munster Medizinische Klinik ARecruiting
Münster, Germany
Irccs Istituto Tumori Giovanni Paolo IiRecruiting
Bari, Italy
Aou Careggi, Servizio Sanitario ToscanaRecruiting
Florence, Italy
Fondazione Irccs Ca Granda Ospedale Maggiore PoliclinicoRecruiting
Milan, Italy
Ospedale San RaffaeleRecruiting
Milan, Italy
Azienda Ospedaliera Universitaria Federico IiRecruiting
Naples, Italy
Aou Maggiore Della CaritaRecruiting
Novara, Italy
Irccs Policlinico San Matteo, Universita Degli Studi Di PaviRecruiting
Pavia, Italy
Ospedale Santa Maria Della MisericordiaRecruiting
Perugia, Italy
Fondazione Policlinico Universitario Agostino GemelliRecruiting
Roma, Italy
Aichi Cancer Center Hospital Clinical OncologyRecruiting
Nagoya, Aichi-ken, Japan
Nho Shikoku Cancer CenterRecruiting
Matsuyama, Ehime, Japan
Hiroshima Red Cross Hospital and Atomic Bomb Survivors HospitalRecruiting
Hiroshima, Hiroshima, Japan
Aiiku HospitalRecruiting
Sapporo, Hokkaido, Japan
Hyogo Prefectural Amagasaki General Medical CenterRecruiting
AmagasakiCity, Hyōgo, Japan
Kagoshima University HospitalRecruiting
Kagoshima, Kagoshima-ken, Japan
University Hospital, Kyoto Prefectural Univ of MedicineRecruiting
KyotoShi, Kyoto, Japan
Tohoku University HospitalRecruiting
Sendai, Miyagi, Japan
Niigata University Medical and Dental HospitalRecruiting
Niigata, Niigata, Japan
Kurashiki Central HospitalRecruiting
Kurashikishi, Okayama-ken, Japan
Kansai Medical University HospitalRecruiting
Hirakata, Osaka, Japan
Kindai University HospitalRecruiting
Sakai, Osaka, Japan
Saitama Medical CenterRecruiting
Kawagoeshi, Saitama, Japan
Ntt Medical Center TokyoRecruiting
Shinagawaku, Tokyo, Japan
Kumamoto University HospitalRecruiting
Kumamoto, Japan
National Hospital Organization Okayama Medical CenterRecruiting
Okayama, Japan
Osaka Metropolitan University HospitalRecruiting
Osaka, Japan
Amsterdam Umc Vu McRecruiting
Amsterdam, Netherlands
Szpital Specjalist W Brzozowie,Podkarpacki Osrodek OnkologicznyRecruiting
Brzozów, Poland
Pratia Onkologia KatowiceRecruiting
Katowice, Poland
Pratia McM KrakowRecruiting
Krakow, Poland
Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W LodziRecruiting
Lodz, Poland
Uniwersytecki Szpital Kliniczny Nr 4 W LublinieRecruiting
Lublin, Poland
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We WroclawiuRecruiting
Wroclaw, Poland
Dong A University HospitalRecruiting
Seogu, Busan Gwang'yeogsi, South Korea
Kyungpook National University HospitalRecruiting
Junggu, Daegu Gwang'yeogsi, South Korea
National Cancer Center (Korea)Recruiting
IlsandongGu GoyangSi, Gyeonggi-do, South Korea
Chonnam National University Hwasun HospitalRecruiting
HwasunGun, Jeollanam-do, South Korea
Samsung Medical CenterRecruiting
GangnamGu, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St Marys HospitalRecruiting
SeochoGu, Seoul Teugbyeolsi, South Korea
Seoul National University HospitalRecruiting
Seoul, Seoul Teugbyeolsi, South Korea
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalRecruiting
Ankara, Turkey (Türkiye)
Gazi UniversityRecruiting
Ankara, Turkey (Türkiye)
Dokuz Eylul UniversityRecruiting
Balçova, Turkey (Türkiye)
Antalya Memorial HospitalRecruiting
Dokuma, Turkey (Türkiye)
Sakarya Training and Research HospitalRecruiting
Sakarya, Turkey (Türkiye)
Aberdeen Royal InfirmaryRecruiting
Aberdeen, United Kingdom
Birmingham Heartlands HospitalRecruiting
Birmingham, United Kingdom
The Royal Bournemouth and Christchurch Hospitals Nhs FoundationRecruiting
Bournemouth, United Kingdom
University College HospitalRecruiting
London, United Kingdom
Royal Marsden HospitalRecruiting
London, United Kingdom
Southampton General HospitalRecruiting
Southampton, United Kingdom