Status:
ACTIVE_NOT_RECRUITING
Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)
Lead Sponsor:
BeOne Medicines
Conditions:
CLL
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The main objective of this study is to compare the efficacy of sonrotoclax plus zanubrutinib versus venetoclax plus obinutuzumab in participants with chronic lymphocytic leukemia (CLL)
Detailed Description
Chronic lymphocytic leukemia is a type of blood cancer that affects people around the world. People with CLL suffer from enlarged lymph nodes, spleen, or liver, or have symptoms like night sweats, wei...
Eligibility Criteria
Inclusion
- Treatment-naïve (TN) adults with confirmed diagnosis of CLL which requires treatment
- Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
- Measurable disease by Computer Tomography/Magnetic Resonance Imaging
- Adequate liver function as indicated by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x the institutional upper limits of normal (ULNs) value; serum total bilirubin \< 3.0 x ULN
- Adequate renal function as defined as creatinine clearance ≥ 50 milliliters per minute
Exclusion
- Previous systemic treatment for CLL
- Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
- Known central nervous system involvement
- History of confirmed progressive multifocal leukoencephalopathy (PML)
- Uncontrolled hypertension
- Note: Other protocol defined criteria may apply
Key Trial Info
Start Date :
November 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2032
Estimated Enrollment :
652 Patients enrolled
Trial Details
Trial ID
NCT06073821
Start Date
November 11 2023
End Date
December 1 2032
Last Update
January 6 2026
Active Locations (203)
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1
Alaska Oncology and Hematology, Llc
Anchorage, Alaska, United States, 99508-2974
2
City of Hope National Medical Center
Duarte, California, United States, 91010-3012
3
University of California San Diego (Ucsd) Moores Cancer Center
La Jolla, California, United States, 92093-1503
4
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067-2011