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

BeOne Medicines

Status and phase: Not yet enrolling; Phase 3

Conditions: Chronic Lymphocytic Leukemia

Treatments: Drug: Zanubrutinib; Drug: Venetoclax; Drug: Acalabrutinib; Drug: Sonrotoclax

Study type: Interventional

Funder types: Industry

Identifiers

NCT07277231

BGB-11417-304

2025-524366-21-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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).

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

500 participants in 2 patient groups

Arm A: Sonrotoclax plus Zanubrutinib

Experimental group

Description:

Participants will receive sonrotoclax and zanubrutinib for a fixed duration followed by observation.

Treatment:

Drug: Sonrotoclax

Drug: Zanubrutinib

Arm B: Venetoclax plus Acalabrutinib

Active Comparator group

Description:

Participants will receive venetoclax and acalabrutinib for a fixed duration followed by observation.

Treatment:

Drug: Acalabrutinib

Drug: Venetoclax