A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Patients With Previously Untreated Chronic Lymphocytic Leukemia
Primary Objective
To compare efficacy between Arm A (sonrotoclax plus zanubrutinib [SZ]) versus Arm B
(venetoclax plus obinutuzumab [VO]), as measured by progression-free survival (PFS)
determined by independent review committee (IRC).'
Key Secondary Objectives
To further compare the efficacy of Arms A and B, as measured by the following endpoints:
Overall complete response rate (CRR) defined as the proportion of patients that
achieved best response of complete response (CR)/complete response with
incomplete hematopoietic recovery (CRi), determined by IRC.
Undetectable measurable residual disease at < 10-4 sensitivity (uMRD4) rate at the
first Post-Treatment Follow-up (PTFU 1) Visit based on next-generation
sequencing (NGS).
Overall survival (OS), defined as time from the date of enrollment to the date of
death because of any cause.
Sonrotoclax (BGB-11417)
Venetoclax (ABT-199)
Gazyva (obinutuzumab)
- Rutgers Cancer Institute of New Jersey
- Principal Investigator
- Joanna Rhodes MD
- Principal Investigator
- RWJBarnabas Health
- Monmouth Medical Center
- Monmouth Medical Center Vantage Point Center
- Trinitas Hospital and Comprehensive Cancer Center
Inclusion Criteria
- 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 Criteria
- 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
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.