Tests tacabrutideg against standard drugs in chronic lymphocytic leukemia
Tests tacabrutideg against standard drugs in adults with leukemia or lymphoma previously treated.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Bari, Florence, Milan, Naples, Novara, Pavia, Perugia, and Rome, ItalySee the 9 sites
- Phase
- Phase 3
Where in Italy
- Istituto Tumori Bari Giovanni Paolo IIBari, ItalyTaking people
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyTaking people
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyTaking people
- Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
- Azienda Ospedaliera Universitaria Federico II Di NapoliNaples, ItalyTaking people
- Azienda Ospedaliero Universitaria Maggiore della CaritàNovara, ItalyTaking people
- Fondazione IRCCS Policlinico San MatteoPavia, ItalyTaking people
- Azienda Ospedaliera di PerugiaPerugia, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- BeOne Medicines
- Trial code
- NCT06846671EU 2024-518893-15-00
- Record updated
- 28 September 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: 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.
Exclusion: Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 months; Prior exposure to any BTK protein degraders; Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation; Active fungal, bacterial and/or viral infection requiring parenteral systemic therapy; Clinically significant cardiovascular disease; NOTE: Other protocol defined Inclusion/Exclusion criteria may apply; Known central nervous system involvement.