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RecruitingInterventionalPhase 3

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

NCT ID: NCT07277231Sponsor: BeOne MedicinesLast updated: 2026-06-18

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).

Arms & interventions

  • DrugSonrotoclax

    Administered orally.

  • DrugZanubrutinib

    Administered orally.

  • DrugAcalabrutinib

    Administered orally.

  • DrugVenetoclax

    Administered orally.

Outcome measures

Primary

  • Progression-Free Survival (PFS) as Determined by Independent Review Committee (IRC)

    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.

    Time frame: Up to approximately 70 months

  • Rate of Undetectable Minimal Residual Disease at < 10^-4 sensitivity (uMRD4)

    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).

    Time frame: Up to approximately 16 months

Secondary

  • PFS in High-Risk Participants

    Time frame: Up to approximately 70 months

  • Overall Survival (OS)

    Time frame: Up to approximately 70 months

  • Overall Response Rate (ORR) as Determined by IRC

    Time frame: Up to approximately 70 months

  • Rate of Undetectable Minimal Residual Disease at < 10^-5 sensitivity (uMRD5)

    Time frame: Up to approximately 16 months

  • Number of Participants with Adverse Events

    Time frame: Up to approximately 70 months

  • PFS Determined by Investigator Assessment

    Time frame: Up to approximately 70 months

  • Complete Response Rate (CRR) by IRC and Investigator Assessment

    Time frame: Up to approximately 70 months

  • ORR Determined by Investigator Assessment

    Time frame: Up to approximately 70 months

  • Duration of Response (DOR)

    Time frame: Up to approximately 70 months

  • Time to Next Treatment (TTNT)

    Time frame: Up to approximately 70 months

  • Change from Baseline in Score on European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL)-409 Questionnaire

    Time frame: At baseline and up to approximately 70 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (2)

Stanford Cancer Institute

Palo Alto, California, 94304-2205

Recruiting

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-4433

Recruiting