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A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia
A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia

NCT07277231

RecruitingPhase 3

Sponsor: BeOne Medicines

Conditions: Chronic Lymphocytic Leukemia

Interventions: Sonrotoclax, Zanubrutinib, Acalabrutinib, Venetoclax

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

The purpose of this study is to investigate the efficacy and safety of fixed-duration sonrotoclax (also known as BGB-11417) plus zanubrutinib (also known as BGB-3111) (SZ) compared with fixed-duration of venetoclax plus acalabrutinib (AV) in participants with previously untreated 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 bone marrow and organ function

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 or clinically significant cardiovascular disease

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations (105)
  • Duarte, California, United States
  • Orange, California, United States
  • Palo Alto, California, United States
  • Aurora, Colorado, United States
  • Miami, Florida, United States
  • Chicago, Illinois, United States
  • Zion, Illinois, United States
  • New Orleans, Louisiana, United States
  • Omaha, Nebraska, United States
  • Pittsburgh, Pennsylvania, United States
  • Tyler, Texas, United States
  • Seattle, Washington, United States
  • Milwaukee, Wisconsin, United States
  • Blacktown, New South Wales, Australia
  • Concord, New South Wales, Australia
  • St Leonards, New South Wales, Australia
  • Woolloongabba, Queensland, Australia
  • Clayton, Victoria, Australia
  • Heidelberg, Victoria, Australia
  • Malvern, Victoria, Australia
  • Melbourne, Victoria, Australia
  • Brasília, Brazil
  • Porto Alegre, Brazil
  • Salvador, Brazil
  • São Paulo, Brazil
  • São Paulo, Brazil
  • Victoria, British Columbia, Canada
  • Hamilton, Ontario, Canada
  • Montreal, Quebec, Canada
  • Montreal, Quebec, Canada
  • + 75 more on CT.gov