A Study to Investigate Sonrotoclax Combined With Zanubrutinib Versus Zanubrutinib Alone in Participants With Previously Untreated Chronic Lymphocytic Leukemia

Korábbi kezelés

• Received previous systemic treatment for CLL
• History of stroke or intracranial hemorrhage ≤ 6 months before the first dose of study treatment
• Use of investigational agents within the last 4 weeks before screening

Más betegség

• Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
• Clinically significant cardiovascular disease
• Severe or debilitating pulmonary disease
• History of prior malignancy
• Active fungal, bacterial, and/or viral infection requiring systemic therapy
• Positive human immunodeficiency virus (HIV) serology (HIVAb) status or serologic status reflecting active hepatitis B or C infection
• Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring treatment
• History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention
• Unable to swallow capsules or tablets or diseases significantly affecting GI function
• Hypersensitivity to zanubrutinib, sonrotoclax, or any of its excipients

Egyéb

• Known central nervous system involvement
• Pregnant and lactating females
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply

• Previously untreated adult patient ≥ 18 years with a confirmed diagnosis of CLL.
• CLL requiring treatment as per pre-defined criteria.
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0,1, or 2.
• Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI).
• Adequate marrow function.
• Adequate liver function as indicated by aspartate aminotransferase (AST) alanine aminotransferase (ALT) and serum total bilirubin.
• Adequate renal function.
• Life expectancy > 6 months.
• Signed informed consent and able to comply with the study protocol in the investigator's judgment.
• Women of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 90 days after the last dose of study drug.