Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinu… (NCT06073821) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)
United States652 participantsStarted 2023-11-11
Plain-language 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)
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Treatment-naĂŻve (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
What they're measuring
1
Cohort 1: Progression Free Survival (PFS)
Timeframe: Up to approximately 9 years
2
Cohort 1: Rate of Undetectable Measurable Residual Disease