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 (121) 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
Arkansas
St Bernards Medical Center
NOT_YET_RECRUITING
Jonesboro
California
UCLA Department of Medicine Hematologyoncology
NOT_YET_RECRUITING
Los Angeles
Pih Health Whittier Hospital
NOT_YET_RECRUITING
Whittier
Colorado
Rocky Mountain Cancer Centers (Williams) Usor
NOT_YET_RECRUITING
Aurora
Florida
Florida Oncology and Hematology
NOT_YET_RECRUITING
Fort Myers
Cleveland Clinic Florida
NOT_YET_RECRUITING
Weston
Georgia
Emory University Winship Cancer Institute
NOT_YET_RECRUITING
Atlanta
Louisiana
Our Lady of the Lake Hospital
NOT_YET_RECRUITING
Baton Rouge
Maryland
American Oncology Partners of Maryland Pa
NOT_YET_RECRUITING
Bethesda
Michigan
Corewell Health the Michigan Cancer Consortium
NOT_YET_RECRUITING
Grand Rapids
Missouri
Oncology Hematology Associates
NOT_YET_RECRUITING
Springfield
Nebraska
Oncology Hematology West, Pc Dba Nebraska Cancer Specialists
RECRUITING
Omaha
New York
Memorial Sloan Kettering Cancer Center Mskcc
NOT_YET_RECRUITING
New York
Clinical Research Alliance, Inc
NOT_YET_RECRUITING
Westbury
Ohio
University Hospitals
SUSPENDED
Cleveland
Oregon
Oncology Associates of Oregon Willamette Valley Cancer Center
NOT_YET_RECRUITING
Eugene
Pennsylvania
West Penn Hospital
NOT_YET_RECRUITING
Pittsburgh
Cancer Care Associates of York
RECRUITING
York
Texas
Texas Oncology Tyler
NOT_YET_RECRUITING
Tyler
West Virginia
Wvu Medicine, Wheeling Hospital
NOT_YET_RECRUITING
Wheeling
Other Locations
Argentina
FUNDALEU
NOT_YET_RECRUITING
Caba
Hospital Aleman
NOT_YET_RECRUITING
Caba
Hospital Italiano de Buenos Aires
NOT_YET_RECRUITING
Ciudad Autonoma Buenos Aires
Instituto Alexander Fleming (Iaf)
NOT_YET_RECRUITING
Ciudad Autonoma Buenos Aires
Australia
Flinders Medical Centre
NOT_YET_RECRUITING
Bedford Pk
Concord Repatriation General Hospital
RECRUITING
Concord
Gosford Hospital
NOT_YET_RECRUITING
Gosford
The Alfred Hospital
RECRUITING
Melbourne
Port Macquarie Base Hospital
NOT_YET_RECRUITING
Port Macquarie
Toowoomba Hospital
RECRUITING
Toowoomba
Perth Blood Institute
RECRUITING
West Perth
Brazil
CETUS
RECRUITING
Belo Horizonte
Hospital Sirio Libanes Brasilia
NOT_YET_RECRUITING
Brasília
Hospital Erasto Gaertner
NOT_YET_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
NOT_YET_RECRUITING
Niterói
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
NOT_YET_RECRUITING
Porto Alegre
Hospital Santa Joana Recife
NOT_YET_RECRUITING
Recife
Hospital Sao Lucas Dasa Oncologia
NOT_YET_RECRUITING
Rio De Janeiro
Oncoclinicas Rio de Janeiro Sa
RECRUITING
Rio De Janeiro
Hospital Sao Rafael (Rede Dor)
NOT_YET_RECRUITING
Salvador
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
Canada
Centre Integre de Sante Et de Services Sociaux de La Monteregie Centre
NOT_YET_RECRUITING
Greenfield Park
London Health Sciences Centre
NOT_YET_RECRUITING
London
Jewish General Hospital
NOT_YET_RECRUITING
Montreal
The Ottawa Hospital Cancer Centre
NOT_YET_RECRUITING
Ottawa
Unite de Recherche Clinique Du Cisss Des Laurentides
NOT_YET_RECRUITING
Saintjerome
Germany
Universitatsklinikum Augsburg
NOT_YET_RECRUITING
Augsburg
Praxis Am Volkspark
NOT_YET_RECRUITING
Berlin
Klinikum Chemnitz Ggmbh
NOT_YET_RECRUITING
Chemnitz
Universitatsklinikum Essen (Aor)
NOT_YET_RECRUITING
Essen
Centrum Fur Haematologie Und Onkologie Bethanien
NOT_YET_RECRUITING
Frankfurt Am Main
Universitatsklinikum Freiburg I Br Klinik Fur Innere Medizin I
NOT_YET_RECRUITING
Freiburg Im Breisgau
Universitatsklinikum Hamburg Eppendorf
NOT_YET_RECRUITING
Hamburg
Universitatsklinikum Heidelberg
NOT_YET_RECRUITING
Heidelberg
Saarland University Medical Center
NOT_YET_RECRUITING
Homburg
Invo Institut Fur Versorgungsforschung in Der Onkologie
RECRUITING
Koblenz
Universitaetsklinikum Leipzig Aor
NOT_YET_RECRUITING
Leipzig
Universitatsklinikum Munster Medizinische Klinik A
NOT_YET_RECRUITING
Münster
Krankenhaus Der Barmherzigen Bruder
NOT_YET_RECRUITING
Regensburg
Italy
Irccs Istituto Tumori Giovanni Paolo Ii
RECRUITING
Bari
Aou Careggi, Servizio Sanitario Toscana
RECRUITING
Florence
Fondazione Irccs Ca Granda Ospedale Maggiore Policlinico
NOT_YET_RECRUITING
Milan
Ospedale San Raffaele
NOT_YET_RECRUITING
Milan
Azienda Ospedaliera Universitaria Federico Ii
NOT_YET_RECRUITING
Napoli
Aou Maggiore Della Carita
RECRUITING
Novara
Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi
NOT_YET_RECRUITING
Pavia
Ospedale Santa Maria Della Misericordia
NOT_YET_RECRUITING
Perugia
Fondazione Policlinico Universitario Agostino Gemelli
RECRUITING
Roma
Japan
Hyogo Prefectural Amagasaki General Medical Center
RECRUITING
Amagasakicity
Chiba Cancer Center
NOT_YET_RECRUITING
Chiba
Kansai Medical University Hospital
NOT_YET_RECRUITING
Hirakata
Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
RECRUITING
Hiroshima
Kagoshima University Hospital
RECRUITING
Kagoshima
National Cancer Center Hospital East
NOT_YET_RECRUITING
Kashiwa
Saitama Medical Center
RECRUITING
Kawagoeshi
Kumamoto University Hospital
RECRUITING
Kumamoto
Kurashiki Central Hospital
NOT_YET_RECRUITING
Kurashikishi
University Hospital, Kyoto Prefectural Univ of Medicine
RECRUITING
Kyotoshi
Nho Shikoku Cancer Center
NOT_YET_RECRUITING
Matsuyama
Aichi Cancer Center Hospital Clinical Oncology
NOT_YET_RECRUITING
Nagoya
Niigata University Medical and Dental Hospital
RECRUITING
Niigata
National Hospital Organization Okayama Medical Center
RECRUITING
Okayama
Osaka Metropolitan University Hospital
NOT_YET_RECRUITING
Osaka
Aiiku Hospital
RECRUITING
Sapporo
Kindai University Hospital
NOT_YET_RECRUITING
Sayama
Tohoku University Hospital
NOT_YET_RECRUITING
Sendai
Ntt Medical Center Tokyo
NOT_YET_RECRUITING
Shinagawaku
Netherlands
Amsterdam Umc Vu Mc
NOT_YET_RECRUITING
Amsterdam
Radboud Universitair Medisch Centrum
NOT_YET_RECRUITING
Nijmegen
New Zealand
North Shore Hospital
NOT_YET_RECRUITING
Auckland
Poland
Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny
NOT_YET_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
NOT_YET_RECRUITING
Hwasungun
National Cancer Center (Korea)
NOT_YET_RECRUITING
Ilsandonggu Goyangsi
Kyungpook National University Hospital
NOT_YET_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
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
NOT_YET_RECRUITING
Ankara
Gazi University
NOT_YET_RECRUITING
Ankara
Dokuz Eylul University
NOT_YET_RECRUITING
Balçova
Antalya Memorial Hospital
RECRUITING
Dokuma
Sakarya Training and Research Hospital
NOT_YET_RECRUITING
Sakarya
United Kingdom
Aberdeen Royal Infirmary
NOT_YET_RECRUITING
Aberdeen
Birmingham Heartlands Hospital
NOT_YET_RECRUITING
Birmingham
The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
NOT_YET_RECRUITING
Bournemouth
Churchill Hospital Oxford University Hospital Nhs Trust
NOT_YET_RECRUITING
Headington
Royal Marsden Hospital
NOT_YET_RECRUITING
London
University College Hospital
RECRUITING
London
Nottingham University Hospitals Nhs Trust
NOT_YET_RECRUITING
Nottingham
Southampton General Hospital
NOT_YET_RECRUITING
Southampton
Contact Information
Primary
Study Director
clinicaltrials@beigene.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: BeiGene