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RecruitingLast updated: 17 April 2026

BGB-11417-304: Comparing two targeted treatment combinations for people with previously untreated, chronic lymphocytic leukaemia (CLL)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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

BGB-11417-304

Clinical summary

Summary

The purpose of this study is to compare the safety and effectiveness of two targeted treatment combinations.

The study is recruiting people with previously untreated chronic lymphocytic leukaemia (CLL).

Eligible participants will be randomly allocated (by chance) to one of two treatment arms.

In Arm A (Experimental), participants will receive the combination SZ. This consists of oral sonrotoclax and oral zanubrutinib for a fixed duration followed by observation.

In Arm B (Active Comparator), participants will receive the combination AV. This consists of oral venetoclax and oral acalabrutinib for a fixed duration followed by observation. 

Conditions

This trial is treating people with treatment-naive chronic lymphocytic leukaemia that requires treatment (TN CLL)

Eligibility

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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You are able to swallow medication by mouth.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

Trial sponsor

BeOne Medicines

Scientific 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

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