Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
Eligible participants will be randomly allocated to one of two treatment arms. Both arms will receive a combination of targeted therapy. Treatment cycles are 28 days.
In the Experimental Arm, participants will receive Sonrotoclax plus Zanubrutinib. Participants will receive, from the start of Cycle 1, a standard dose of oral zanubrutinib once or twice daily, and in combination with oral sonrotoclax starting from Cycle 4 onwards at increasing doses until the target dose is reached and continuing until end of Cycle 15.
In the Active Comparator Arm, participants will receive Venetoclax plus Obinutuzumab. Participants will receive obinutuzumab 100mg intravenously on Day 1 Cycle 1, followed by 900mg on Day 2 Cycle 1 (or alternatively receive 1000mg intravenously on Day 1) followed by 1000mg on Days 8 and 15 of Cycle 1, and thereafter on Day 1 of Cycles 2 through 6 in combination with oral venetoclax at increasing doses until target dose is reached from Day 22 Cycle 1 until end of Cycle 12.
Conditions
This trial is treating patients with chronic lymphocytic leukaemia who have not had prior treatment
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 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
- 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
Inclusion
- You have been diagnosed with cancer, but have not received any treatment.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
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.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
BeiGene
Scientific Title
A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Patients With Previously Untreated Chronic Lymphocytic Leukemia
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