A Study to Assess the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Cell Lymphocytic Lymphoma
Summary description of the study
The aim of this study is to assess the efficacy and safety of BGB-16673 compared to Pirtobrutinib in patients with relapsed and/or refractory (R/R) chronic lymphocytic leukemia (CLL) or small cell lymphocytic lymphoma (SLL) who have previously been treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi). Study details: The duration of the study is approximately 3.5 years, excluding the pre-study period. Patients will receive treatment until unacceptable toxicity occurs or disease progression is confirmed by both the investigator and the IRC, or one of the specified criteria for treatment discontinuation is met, whichever occurs first. Refractory to previous cBTKi therapy – Patients who experienced disease progression between the first dose of the last cBTKi therapy and six months after the last dose of the last cBTKi therapy are considered refractory to the last cBTKi therapy. Relapse – The reoccurrence of CLL/SLL after a remission phase.
(BASEC)
Intervention under investigation
Arm A: Patients randomized to Arm A will receive BGB-16673 200 mg orally once daily until one of the criteria for treatment discontinuation listed in Section 7.1 is met. Arm B: Patients randomized to Arm B will receive Pirtobrutinib 200 mg orally once daily.
(BASEC)
Disease under investigation
Relapsed and/or refractory (R/R) chronic lymphocytic leukemia (CLL) or small cell lymphocytic lymphoma (SLL)
(BASEC)
1. Confirmed diagnosis of CLL or SLL requiring treatment according to iwCLL 2018 criteria. 2. Prior treatment for CLL/SLL with a covalent Bruton tyrosine kinase inhibitor (cBTKi). Patients should have relapsed or been refractory after at least one prior line of therapy, including treatment with a covalent BTK inhibitor (cBTKi). For patients with SLL, there must be measurable disease defined by computed tomography/magnetic resonance imaging as ≥ 1 lymph node with a diameter of > 1.5 cm in the longest dimension and measurable in 2 perpendicular diameters.
(BASEC)
Exclusion criteria
1. Known prolymphocytic leukemia, history of prolymphocytic leukemia, or current suspicion of Richter transformation. 2. Current or prior central nervous system involvement by CLL/SLL, including brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy). 3. History of ischemic stroke or intracranial hemorrhage within months prior to the first dose of the study drug. 4. Prior treatment with a protein degrader of Bruton tyrosine kinase (BTK) or non-covalent BTK inhibitor (ncBTKi). Patients who discontinued treatment with cBTKi solely due to toxicity are not eligible. 5. History of a known bleeding disorder such as hemophilia A, hemophilia B, or von Willebrand disease, or history of spontaneous bleeding that required a blood transfusion or other medical intervention.
(BASEC)
Trial sites
Bern, Zurich
(BASEC)
Sponsor
BeOne Medicines I GmbH Aeschengraben 27 CH-4051 Basel, Switzerland
(BASEC)
Contact
Contact Person Switzerland
Ivana Murfuni
+18778285568
clinicaltrials@clutterbeonemed.comBeOne Medicines I GmbH
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
30.01.2026
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
A Phase 3, Open-Label, Randomized Trial to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
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Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
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Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
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