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RecruitingPhase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two drug pairs for adults with chronic lymphocytic leukemia (CLL), a type of blood cancer, who have not had treatment. It tests how well sonrotoclax plus zanubrutinib works and how safe it is compared with venetoclax plus acalabrutinib. Both drug pairs are given for a set length of time.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Adults with confirmed CLL that needs treatment and has not been treated before.
  • Able to do all or most daily activities, or able to care for yourself and be up for more than half the day (ECOG score 0–2).
  • Cancer that can be measured on a CT or MRI scan.
  • Bone marrow, which makes blood cells, and organs must work well enough.

Who can't join

  • Past treatment for CLL with drugs that work throughout the body.
  • Known prolymphocytic leukemia, another type of blood cancer.
  • Past or suspected Richter's transformation, when CLL changes into a faster-growing cancer.
  • Known cancer in the brain or spinal cord.
  • Past confirmed progressive multifocal leukoencephalopathy (PML), a serious brain infection.
  • High blood pressure that is not controlled, or significant heart or blood vessel disease.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (22)

CA

CO

FL

IL

LA

MA

MN

NC

NE

NY

OR

PA

TX

UT

WA

WI