Clinical Trial 24266

• Overview

  Study Title:

  A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) plus Zanubrutinib (BGB-3111) Compared with Venetoclax plus Acalabrutinib in Patients with Previously Untreated Chronic Lymphocytic Leukemia

  Summary:

  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).

  Objective:

  Primary Objective: To compare efficacy between Arm A (SZ) vs Arm B (AV), as measured by PFS determined by the Independent Review Committee (IRC) in all enrolled patients. Intermediate Objective: To compare the rate of undetectable MRD at < 10-4 sensitivity (uMRD4) in both PB and BMA among patients enrolled to Arm A vs Arm B. Secondary Objectives: To compare PFS determined by IRC among high-risk patients enrolled to Arm A vs Arm B. To compare overall survival (OS) among patients enrolled to Arm A vs Arm B.

• Treatments

  Therapies:

  BCL-2 inhibitor; BTK Inhibitor

  Medications:

  ACP-196 (Acalabrutinib); Acalabrutinib (); GDC-0199 (Venetoclax); Sonrotoclax (); Venetoclax (); Zanubrutinib ()

• Inclusion Criteria

  Key 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.
  • Other protocol defined Inclusion/Exclusion criteria may apply.

• Exclusion Criteria

  Key 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.
  • Other protocol defined Inclusion/Exclusion criteria may apply.

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