Sonrotoclax plus zanubrutinib versus venetoclax plus acalabrutinib for adults with untreated CLL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3, randomized comparison enrolls adults with previously untreated CLL requiring therapy to receive one of two fixed-duration targeted regimens: sonrotoclax (BGB-11417) plus zanubrutinib (BGB-3111) or venetoclax plus acalabrutinib. Participants must have measurable disease, ECOG 0–2, and adequate bone marrow and organ function, with key exclusions for prior systemic CLL therapy, CNS involvement, Richter's transformation, or history of PML. The trial will compare efficacy and safety outcomes with regular imaging and laboratory monitoring during and after the fixed treatment period. Standard supportive care and monitoring for expected toxicities (for example, tumor lysis and cardiovascular events) are included in the protocol.

Why it matters

Who can join: the full rules

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.

Where it's running

• City of Hope National Medical Center
  Duarte, California, United States Recruiting
• Chao Family Comprehensive Cancer Center
  Orange, California, United States Recruiting
• Stanford Cancer Institute
  Palo Alto, California, United States Recruiting
• Rocky Mountain Cancer Centers (Williams) Usor
  Aurora, Colorado, United States Recruiting
• Mayo Clinic Jacksonville
  Jacksonville, Florida, United States Recruiting
• Mount Sinai Medical Center Braman Comprehensive Cancer Center
  Miami, Florida, United States Recruiting

+65 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Director
• Email: clinicaltrials@beonemed.com
• Phone: 8778285568

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Venetoclax plus Zanubrutinib for CLL/SLL in frontline or previously treated patients

  This phase II trial tests if venetoclax plus zanubrutinib can safely and effectively treat adults with chronic lymphocytic leukemia or small lymphocytic lymphoma, including those who are newly diagnosed and those who have had prior therapy.

  Recruiting Phase 2 Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT07734038

• Tafasitamab plus Acalabrutinib and Venetoclax for newly treated CLL/SLL

  This phase II study tests a combination of tafasitamab, acalabrutinib, and venetoclax in adults who are newly diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma to see if it is safe and effective.

  Recruiting at 2 sites Phase 2 City of Hope Medical Center · Duarte, California and 1 other locations · NCT07582159

• Adding a targeted cancer drug to standard therapy for untreated CLL/SLL

  This trial tests whether adding sonrotoclax to zanubrutinib helps people with untreated CLL/SLL live longer without the disease getting worse.

  Recruiting at 259 sites Phase 3 Alliance for Clinical Trials in Oncology · Birmingham, Alabama and 260 other locations · NCT07321652

• Acalabrutinib for CLL in routine care in Belarus

  This project will see how well acalabrutinib works and how safe it is for adults with chronic lymphocytic leukemia treated in routine clinical practice in Belarus.

  Recruiting at 3 sites AstraZeneca · Grodno and 3 other locations · NCT07288515

• Intermittent versus continuous venetoclax with acalabrutinib in CLL/SLL

  This will test whether giving venetoclax intermittently or continuously together with acalabrutinib helps people with previously untreated CLL or SLL.

  Recruiting Phase 2 University of Cincinnati · Cincinnati, Ohio · NCT07014917

• Zanubrutinib, obinutuzumab, and sonrotoclax for newly diagnosed CLL or SLL

  This trial tests whether the three‑drug combination of zanubrutinib, obinutuzumab, and sonrotoclax can produce undetectable measurable residual disease (uMRD) in people with previously untreated CLL or SLL.

  Recruiting at 2 sites Phase 2 Massachusetts General Hospital · Boston, Massachusetts and 1 other locations · NCT06849713

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.