Comparing two treatment combinations for chronic lymphocytic leukemia

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 study aims to evaluate the effectiveness of sonrotoclax combined with zanubrutinib against the standard treatment of venetoclax plus obinutuzumab in patients with chronic lymphocytic leukemia (CLL) who have not received prior treatment. Participants will be randomly assigned to one of the two treatment groups, and the primary outcome will be the duration of time participants live without their CLL worsening. The study will enroll approximately 652 participants globally, focusing on improving treatment outcomes for this blood cancer.

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 liver function as indicated by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x the institutional upper limits of normal (ULNs) value; serum total bilirubin \< 3.0 x ULN
* Adequate renal function as defined as creatinine clearance ≥ 50 milliliters per minute

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

Note: Other protocol defined criteria may apply

Where it's running

• Aichi Cancer Center Hospital Clinical Oncology
  Nagoya, Aichi, Japan Recruiting
• Chiba Cancer Center
  Chibashi, Chiba, Japan Recruiting
• Nho Shikoku Cancer Center
  MatsuyamaShi, Ehime, Japan Recruiting
• Aiiku Hospital
  SapporoShi, Hokkaido, Japan Recruiting
• Hyogo Prefectural Amagasaki General Medical Center
  AmagasakiCity, Hyogo, Japan Recruiting
• Kagoshima University Hospital
  Kagoshimashi, Kagoshima, Japan Recruiting

+160 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Director
• Email: clinicaltrials@beigene.com
• Phone: 1-877-828-5568

Similar studies

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

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• Epcoritamab given after 2nd-generation BTK inhibitors for CLL/SLL

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• 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.

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• Combining Zanubrutinib and Obinutuzumab for Treating Newly Diagnosed Follicular Lymphoma

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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.