Clinical trial NCT06973187: A Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Keywords: Noncovalent Bruton tyrosine kinase inhibitor
Bruton tyrosine kinase-targeted protein degrader
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2025-05-15
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of BGB-16673 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).


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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
* 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).
* 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.

Primary outcomes:
measure: Progression-Free Survival (PFS) per Independent Review Committee (IRC)
timeFrame: Up to approximately 3 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 3 years
measure: PFS per Investigator (INV)
timeFrame: Up to approximately 3 years
measure: Overall Response Rate (ORR) per IRC and INV
timeFrame: Up to approximately 3 years
measure: Rate of Partial Response with Lymphocytosis (PR-L) or Higher per IRC and INV
timeFrame: Up to approximately 3 years
measure: Duration of Response (DOR) per IRC and INV
timeFrame: Up to approximately 3 years
measure: Time to Next Anti-CLL/SLL Treatment (TTNT)
timeFrame: Up to approximately 3 years
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to approximately 3 years
measure: Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire EORTC IL409
timeFrame: Baseline and up to approximately 3 years
Other outcomes:
Locations:
Study officials:
affiliation: BeiGene
name: Study Director
role: STUDY_DIRECTOR
References: