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Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)

NCT06073821

Active Not RecruitingPhase 3

Sponsor: BeOne Medicines

Conditions: CLL

Interventions: Sonrotoclax, Zanubrutinib, Venetoclax, Obinutuzumab

Countries: United States, Australia, Austria, Brazil, Canada, China, Czechia, France

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)

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (201)

Anchorage, Alaska, United States
Duarte, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Orange, California, United States
Palo Alto, California, United States
Aurora, Colorado, United States
Washington D.C., District of Columbia, United States
Miami, Florida, United States
Tampa, Florida, United States
Newnan, Georgia, United States
Chicago, Illinois, United States
Peoria, Illinois, United States
Fort Wayne, Indiana, United States
Iowa City, Iowa, United States
Waukee, Iowa, United States
Westwood, Kansas, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Minneapolis, Minnesota, United States
St Louis, Missouri, United States
Hackensack, New Jersey, United States
New Brunswick, New Jersey, United States
New York, New York, United States
Westbury, New York, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Cleveland, Ohio, United States
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