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
Status: Recruiting
Location: See all (23) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Florida
Cancer Specialists of North Florida
RECRUITING
Jacksonville
Mount Sinai Comprehensive Cancer Center
RECRUITING
Miami Beach
Louisiana
Mary Bird Perkins Cancer Center
RECRUITING
Baton Rouge
Missouri
Washington University School of Medicine
RECRUITING
St Louis
Ohio
Dayton Physician Network
RECRUITING
Dayton
Virginia
Blue Ridge Cancer Care (Oncology and Hematology Associates of Southwest Virginia)