Compares tacabrutideg with pirtobrutinib in relapsed leukemia or lymphoma
Compares tacabrutideg with pirtobrutinib in adults with CLL or SLL that returned after treatment.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Safety and Efficacy of Tacabrutideg (BGB-16673) Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Key facts
- Where
- Bunkyoku, Fukushima, Hiroshima, Koshigaya, Kōtoku, Kumamoto, Kyotoshi, Matsuyama, Nagoya, Nakamuraku, Nankoku, Ōita, Okayama, Osaka, Sakai, Sapporo, Tachikawashi, and Yamagata, JapanSee the 18 sites
- Phase
- Phase 3
Where in Japan
- Tokyo Metropolitan Komagome HospitalBunkyoku, JapanTaking people
- Fukushima Medical University HospitalFukushima, JapanTaking people
- Hiroshima Red Cross Hospital and Atomic Bomb Survivors HospitalHiroshima, JapanTaking people
- Dokkyo Medical University Saitama Medical CenterKoshigaya, JapanTaking people
- Cancer Institute Hospital of JFCRKōtoku, JapanTaking people
- Kumamoto University HospitalKumamoto, JapanTaking people
- Japanese Red Cross Kyoto Daini HospitalKyotoshi, JapanTaking people
- Matsuyama Red Cross HospitalMatsuyama, JapanTaking people
- Aichi Cancer Center Hospital Clinical OncologyNagoya, JapanTaking people
- Japanese Red Cross Aichi Medical Center Nagoya Daiichi HospitalNakamuraku, JapanTaking people
- Kochi Medical School HospitalNankoku, JapanTaking people
- Oita Prefectural HospitalŌita, JapanTaking people
- Okayama University HospitalOkayama, JapanTaking people
- Osaka Metropolitan University HospitalOsaka, JapanTaking people
- Kindai University HospitalSakai, JapanTaking people
- Aiiku HospitalSapporo, JapanTaking people
- National Hospital Organization (Nho) Disaster Medical CenterTachikawashi, JapanTaking people
- Yamagata University HospitalYamagata, JapanTaking 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
- NCT06973187EU 2025-522860-34-00
- Record updated
- 28 September 2026
- Original description
The purpose of this study is to evaluate the efficacy and safety of tacabrutideg alone compared with pirtobrutinib in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had been previously treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi).Read full original descriptionShow less
A Phase 3, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
The purpose of this study is to evaluate the efficacy and safety of tacabrutideg alone compared with pirtobrutinib in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had been previously treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi).
Inclusion: Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 iwCLL criteria; Previously received treatment for CLL/SLL with a covalent Bruton tyrosine kinase inhibitor (cBTKi). Patients should have disease relapsed after or refractory to at least 1 line of therapy including a cBTKi; Participants with SLL must have measurable disease by computed tomography/magnetic resonance imaging, defined as ≥ 1 lymph node > 1.5 cm in longest diameter and measurable in 2 perpendicular diameters.
Exclusion: History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug; Prior exposure to any Bruton tyrosine kinase (BTK) protein degraders or noncovalent Bruton tyrosine kinase inhibitor (ncBTKi); Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation; History of known bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention; Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by CLL/SLL; NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.