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
NCT ID: NCT06846671
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
250 participants
INTERVENTIONAL
2025-04-10
2030-02-14
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: BGB-16673 monotherapy
Participants will receive BGB-16673 once daily until any of the treatment discontinuation criteria are met
BGB-16673
Administered orally
Arm B: Investigator's Choice
Participants will receive investigator's choice of idelalisib plus rituximab for CLL only or bendamustine plus rituximab, or venetoclax plus rituximab retreatment.
Bendamustine
Administered intravenously
Idelalisib
Administered orally
Rituximab
Administered intravenously
Venetoclax
Administered orally
Interventions
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BGB-16673
Administered orally
Bendamustine
Administered intravenously
Idelalisib
Administered orally
Rituximab
Administered intravenously
Venetoclax
Administered orally
Eligibility Criteria
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Inclusion 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
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
18 Years
ALL
No
Sponsors
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BeOne Medicines
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeOne Medicines
Locations
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Florida Oncology and Hematology
Fort Myers, Florida, United States
Oncology Hematology Associates
Springfield, Missouri, United States
Oncology Hematology West, Pc Dba Nebraska Cancer Specialists
Omaha, Nebraska, United States
Clinical Research Alliance, Inc
Westbury, New York, United States
Cancer Care Associates of York
York, Pennsylvania, United States
FUNDALEU
Caba, , Argentina
Concord Repatriation General Hospital
Concord, 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
Hospital Sao Lucas Dasa Oncologia
Rio de Janeiro, , Brazil
Oncoclinicas Rio de Janeiro Sa
Rio de Janeiro, , 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
Fakultni Nemocnice Brno
Brno, , Czechia
Fakultni Nemocnice Hradec Kralove
Hradec Králové, , Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, , Czechia
Invo Institut Fur Versorgungsforschung in Der Onkologie
Koblenz, , Germany
Irccs Istituto Tumori Giovanni Paolo Ii
Bari, , Italy
Aou Careggi, Servizio Sanitario Toscana
Florence, , Italy
Ospedale San Raffaele
Milan, , Italy
Aou Maggiore Della Carita
Novara, , Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, , Italy
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
Kansai Medical University Hospital
Hirakata, Osaka, Japan
Kindai University Hospital
Sayama, 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
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 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
Antalya Memorial Hospital
Dokuma, , 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
Countries
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Central Contacts
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Other Identifiers
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2024-518893-15-00
Identifier Type: CTIS
Identifier Source: secondary_id
BGB-16673-302
Identifier Type: -
Identifier Source: org_study_id