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
Status: Recruiting
Location: See all (69) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Florida
Florida Oncology and Hematology
RECRUITING
Fort Myers
Maryland
American Oncology Partners of Maryland Pa
RECRUITING
Bethesda
Missouri
Oncology Hematology Associates
RECRUITING
Springfield
Nebraska
Oncology Hematology West, Pc Dba Nebraska Cancer Specialists
RECRUITING
Omaha
New York
Clinical Research Alliance, Inc
RECRUITING
Westbury
Pennsylvania
Cancer Care Associates of York
RECRUITING
York
Other Locations
Argentina
FUNDALEU
RECRUITING
Caba
Australia
Concord Repatriation General Hospital
RECRUITING
Concord
The Alfred Hospital
RECRUITING
Melbourne
Toowoomba Hospital
RECRUITING
Toowoomba
Perth Blood Institute
RECRUITING
West Perth
Brazil
CETUS
RECRUITING
Belo Horizonte
Hospital Sirio Libanes Brasilia
RECRUITING
Brasília
Hospital Erasto Gaertner
RECRUITING
Curitiba
Centro de Ensino E Pesquisa Em Oncologia de Santa Catarina (Cepen)
RECRUITING
Florianópolis
Instituto Joinvilense de Hematologia E Oncologia
RECRUITING
Joinville
Complexo Hospitalar de Niteroi
RECRUITING
Niterói
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
RECRUITING
Porto Alegre
Hospital Sao Lucas Dasa Oncologia
RECRUITING
Rio De Janeiro
Oncoclinicas Rio de Janeiro Sa
RECRUITING
Rio De Janeiro
Instituto Brasileiro de Controle Do Cancer
RECRUITING
São Paulo
Instituto Dor de Pesquisa E Ensino Sao Paulo
RECRUITING
São Paulo
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
RECRUITING
São Paulo
Hospital Santa Rita de Cassia Afecc
RECRUITING
Vitória
Germany
Universitatsklinikum Augsburg
RECRUITING
Augsburg
Centrum Fur Haematologie Und Onkologie Bethanien
RECRUITING
Frankfurt Am Main
Invo Institut Fur Versorgungsforschung in Der Onkologie
RECRUITING
Koblenz
Universitatsklinikum Munster Medizinische Klinik A
RECRUITING
Münster
Italy
Irccs Istituto Tumori Giovanni Paolo Ii
RECRUITING
Bari
Aou Careggi, Servizio Sanitario Toscana
RECRUITING
Florence
Ospedale San Raffaele
RECRUITING
Milan
Aou Maggiore Della Carita
RECRUITING
Novara
Ospedale Santa Maria Della Misericordia
RECRUITING
Perugia
Fondazione Policlinico Universitario Agostino Gemelli
RECRUITING
Roma
Japan
Hyogo Prefectural Amagasaki General Medical Center
RECRUITING
Amagasakicity
Kansai Medical University Hospital
RECRUITING
Hirakata
Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
RECRUITING
Hiroshima
Kagoshima University Hospital
RECRUITING
Kagoshima
Saitama Medical Center
RECRUITING
Kawagoeshi
Kumamoto University Hospital
RECRUITING
Kumamoto
University Hospital, Kyoto Prefectural Univ of Medicine
RECRUITING
Kyotoshi
Niigata University Medical and Dental Hospital
RECRUITING
Niigata
National Hospital Organization Okayama Medical Center
RECRUITING
Okayama
Osaka Metropolitan University Hospital
RECRUITING
Osaka
Kindai University Hospital
RECRUITING
Sakai
Aiiku Hospital
RECRUITING
Sapporo
Tohoku University Hospital
RECRUITING
Sendai
Ntt Medical Center Tokyo
RECRUITING
Shinagawaku
Poland
Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny
RECRUITING
Brzozów
Pratia Onkologia Katowice
RECRUITING
Katowice
Pratia McM Krakow
RECRUITING
Krakow
Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
RECRUITING
Lodz
Uniwersytecki Szpital Kliniczny Nr W Lublinie
RECRUITING
Lublin
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
RECRUITING
Wroclaw
Republic of Korea
Samsung Medical Center
RECRUITING
Gangnamgu
Chonnam National University Hwasun Hospital
RECRUITING
Hwasungun
National Cancer Center (Korea)
RECRUITING
Ilsandonggu Goyangsi
Kyungpook National University Hospital
RECRUITING
Junggu
The Catholic University of Korea, Seoul St Marys Hospital
RECRUITING
Seochogu
Dong A University Hospital
RECRUITING
Seogu
Seoul National University Hospital
RECRUITING
Seoul
Turkey
Gazi University
RECRUITING
Ankara
Dokuz Eylul University
RECRUITING
Balçova
Antalya Memorial Hospital
RECRUITING
Dokuma
United Kingdom
Aberdeen Royal Infirmary
RECRUITING
Aberdeen
Birmingham Heartlands Hospital
RECRUITING
Birmingham
The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
RECRUITING
Bournemouth
Royal Marsden Hospital
RECRUITING
London
University College Hospital
RECRUITING
London
Contact Information
Primary
Study Director
clinicaltrials@beonemed.com
1.877.828.5568
Time Frame
Start Date: 2025-04-10
Estimated Completion Date: 2030-02-14
Participants
Target number of participants: 250
Treatments
Experimental: Arm A: BGB-16673 monotherapy
Participants will receive BGB-16673 once daily until any of the treatment discontinuation criteria are met
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: BeOne Medicines