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

NCT ID: NCT07277231

Last Updated: 2025-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2031-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Lymphocytic Leukemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm A: Sonrotoclax plus Zanubrutinib

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

Group Type EXPERIMENTAL

Sonrotoclax

Intervention Type DRUG

Administered orally.

Zanubrutinib

Intervention Type DRUG

Administered orally.

Arm B: Venetoclax plus Acalabrutinib

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

Group Type ACTIVE_COMPARATOR

Acalabrutinib

Intervention Type DRUG

Administered orally.

Venetoclax

Intervention Type DRUG

Administered orally.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sonrotoclax

Administered orally.

Intervention Type DRUG

Zanubrutinib

Administered orally.

Intervention Type DRUG

Acalabrutinib

Administered orally.

Intervention Type DRUG

Venetoclax

Administered orally.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

BGB-11417 BGB-3111 Brukinsa Calquence Venclexta Venclyxto

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

BeOne Medicines

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Study Director

Role: STUDY_DIRECTOR

BeOne Medicines

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Study Director

Role: CONTACT

8778285568

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2025-524366-21-00

Identifier Type: CTIS

Identifier Source: secondary_id

BGB-11417-304

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.