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Study of Sonrotoclax Plus Zanubrutinib for Untreated CLL

This study is looking at two different combinations of medicines for adults with chronic lymphocytic leukemia (CLL) that hasn't been treated before. You would receive either sonrotoclax plus zanubrutinib, or venetoclax plus acalabrutinib. All these medicines are taken by mouth. The main goals are to see how long people live without their cancer getting worse (Progression-Free Survival) and to measure how much cancer is left in the body after treatment. To join, you must be an adult with CLL needing treatment, have a good general health score (ECOG 0, 1, or 2), and have measurable disease. This study plans to enroll about 500 people. The current recruitment status is unclear.

Study design
This is an interventional study comparing two different drug combinations. It plans to enroll about 500 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for Progression-Free Survival for up to approximately 70 months, and for Minimal Residual Disease for up to approximately 16 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07277231

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
BeOne Medicines
~500 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:SonrotoclaxZanubrutinibAcalabrutinibVenetoclax

At a glance

Recruiting sites
105 of 105 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (PFS) as Determined by Independent Review Committee (IRC)
Measured over Up to approximately 70 months
+1 more outcome measured

Conditions

Chronic Lymphocytic Leukemia

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Where it's being run

105 sites across 48 states
France7
Czechia6
Brazil5
Italy5
New Zealand5
Poland5
United Kingdom5
Victoria4

Study leadership

  • Study Director · STUDY_DIRECTOR · BeOne Medicines

Who to contact

Study Director
[email protected]
8778285568
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Progression-Free Survival (PFS) as Determined by Independent Review Committee (IRC)Up to approximately 70 months

    PFS is defined as the time from the date of randomization to the date of disease progression as determined by IRC or death due to any cause, whichever occurs first.

  • Rate of Undetectable Minimal Residual Disease at < 10^-4 sensitivity (uMRD4)Up to approximately 16 months

    Rate of uMRD4 is defined as the percentage of participants that achieved uMRD4 measured in both peripheral blood (PB) and bone marrow aspirate (BMA) at the post-treatment follow-up visit (PTFU1) based on next generation sequencing (NGS).