Study of BGB-16673 for CLL or SLL Previously Treated with BTK and BCL2 Inhibitors
This study is for people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) whose cancer has returned or didn't respond to previous treatments, specifically those who have already received both BTK inhibitors and BCL2 inhibitors. You would receive either BGB-16673 (an oral drug) or a standard treatment chosen by your doctor, which could be idelalisib plus rituximab, bendamustine plus rituximab, or venetoclax plus rituximab. The main goal is to see if BGB-16673 can help you live longer without your cancer getting worse, compared to the standard treatments. We expect to include about 250 participants in this study. The study is looking for people aged 18 and older with a confirmed diagnosis of CLL or SLL.
- Study design
- This is an interventional study where approximately 250 participants will be randomly assigned to receive either BGB-16673 or a standard treatment chosen by their doctor.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, Progression-Free Survival, will be measured at approximately 36 months.
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A Study of Tacabrutideg (BGB-16673) Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors
At a glance
Conditions
Where it's being run
130 sites across 52 statesStudy leadership
- Study Director · STUDY_DIRECTOR · BeOne Medicines
Who to contact
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What this trial measures
- Progression-Free Survival (PFS) by Independent Review Committee (IRC)Approximately 36 Months
PFS is defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by IRC using modified 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for participants with chronic lymphocytic leukemia (CLL) and Lugano classification for participants with small lymphocytic lymphoma (SLL).