A Study of Tacabrutideg (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
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
- CLL
- Chronic Lymphocytic Leukemia
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- BeOne Medicines
- Enrolment target
- 250
- Started
- 10 April 2025
- Main results due
- 15 May 2028
- Study sites
- 132
- Registry updated
- 28 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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.
What this study is about
In the sponsor’s own words, from the registry.
The purpose of this study is to investigate the efficacy and safety of tacabrutideg 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).
Study sites(132)
St Bernards Medical Center
Jonesboro, Arkansas, United States
Recruiting
UCLA Department of Medicine Hematologyoncology
Los Angeles, California, United States
Recruiting
Scripps Prebys Cancer Center
San Diego, California, United States
Recruiting
Pih Health Whittier Hospital
Whittier, California, United States
Recruiting
Rocky Mountain Cancer Centers (Williams) Usor
Aurora, Colorado, United States
Recruiting
Intermountain Health Lutheran Hospital Cancer Center of Colorado
Golden, Colorado, United States
Recruiting
Florida Oncology and Hematology
Fort Myers, Florida, United States
Recruiting
Baptist Md Anderson Cancer Center
Jacksonville, Florida, United States
Recruiting
Cleveland Clinic Florida
Weston, Florida, United States
Recruiting
Emory University Winship Cancer Institute
Atlanta, Georgia, United States
Recruiting
Northside Cancer Center
Atlanta, Georgia, United States
Recruiting
Our Lady of the Lake Hospital
Baton Rouge, Louisiana, United States
Recruiting
American Oncology Partners of Maryland Pa
Bethesda, Maryland, United States
Recruiting
Corewell Health the Michigan Cancer Consortium
Grand Rapids, Michigan, United States
Recruiting
University of Minnesota
Minneapolis, Minnesota, United States
Recruiting
St Lukes Center For Cancer Care
Chesterfield, Missouri, United States
Recruiting
Oncology Hematology Associates
Springfield, Missouri, United States
Recruiting
St Vincent Frontier Cancer Center
Billings, Montana, United States
Recruiting
Oncology Hematology West, Pc Dba Nebraska Cancer Specialists
Omaha, Nebraska, United States
Recruiting
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, United States
Recruiting
New York Cancer and Blood Specialists
Shirley, New York, United States
Recruiting
Optum Medical Care, Pc
Westbury, New York, United States
Recruiting
University Hospitals
Cleveland, Ohio, United States
Recruiting
Dayton Physician Network
Dayton, Ohio, United States
Recruiting
Oncology Associates of Oregon Willamette Valley Cancer Center
Eugene, Oregon, United States
Recruiting
West Penn Hospital
Pittsburgh, Pennsylvania, United States
Recruiting
Cancer Care Associates of York
York, Pennsylvania, United States
Recruiting
Baylor Scott and White Health
Temple, Texas, United States
Recruiting
Texas Oncology Tyler
Tyler, Texas, United States
Recruiting
Hospital Aleman
Caba, Argentina
Recruiting
CEMIC
Caba, Argentina
Recruiting
FUNDALEU
Caba, Argentina
Recruiting
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires, Argentina
Recruiting
Instituto Alexander Fleming (Iaf)
Ciudad Autonoma Buenos Aires, Argentina
Recruiting
Cice 9 de Julio Sanatorio 9 de Julio
San Miguel de Tucumán, Argentina
Recruiting
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Recruiting
Gosford Hospital
Gosford, New South Wales, Australia
Recruiting
Port Macquarie Base Hospital
Port Macquarie, New South Wales, Australia
Recruiting
Prince of Wales Hospital
Randwick, New South Wales, Australia
Recruiting
Toowoomba Hospital
Toowoomba, Queensland, Australia
Recruiting
Flinders Medical Centre
Bedford PK, South Australia, Australia
Recruiting
The Alfred Hospital
Melbourne, Victoria, Australia
Recruiting
Perth Blood Institute
West Perth, Western Australia, Australia
Recruiting
CETUS
Belo Horizonte, Brazil
Recruiting
Hospital Sirio Libanes Brasilia
Brasília, Brazil
Recruiting
Hospital Erasto Gaertner
Curitiba, Brazil
Recruiting
Centro de Ensino E Pesquisa Em Oncologia de Santa Catarina (Cepen)
Florianópolis, Brazil
Recruiting
Instituto Joinvilense de Hematologia E Oncologia
Joinville, Brazil
Recruiting
Complexo Hospitalar de Niteroi
Niterói, Brazil
Recruiting
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, Brazil
Recruiting
Hospital Sao Lucas Dasa Oncologia
Rio de Janeiro, Brazil
Recruiting
Oncoclinicas Rio de Janeiro Sa
Rio de Janeiro, Brazil
Recruiting
Hospital Sao Rafael (Rede Dor)
Salvador, Brazil
Recruiting
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo, Brazil
Recruiting
Instituto Brasileiro de Controle Do Cancer
São Paulo, Brazil
Recruiting
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, Brazil
Recruiting
Hospital Santa Rita de Cassia Afecc
Vitória, Brazil
Recruiting
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Recruiting
London Health Sciences Centre
London, Ontario, Canada
Recruiting
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Recruiting
Showing 60 of 132 sites — filter to narrow it down. 132 of the 132 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06846671. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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