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A Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.
EU CTIS ID: 2025-522860-34-00
What this study is testing
To evaluate the efficacy of BGB-16673 compared to pirtobrutinib as measured by progression-free survival (PFS) determined by independent review committee (IRC)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 iwCLL criteria.
- Previously received treatment for CLL/SLL with a covalent Bruton tyrosine kinase inhibitor (cBTKi). Patients should have disease relapsed after or refractory to at least 1 line of therapy including a cBTKi.
- Patients with SLL must have measurable disease by computed tomography/magnetic resonance imaging, defined as ≥ 1 lymph node > 1.5 cm in longest diameter and measurable in 2 perpendicular diameters.
You likely can't join if
- Known prolymphocytic leukemia or history of, or currently suspected, Richter’s transformation.
- Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by CLL/SLL.
- History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug.
- Prior exposure to any Bruton tyrosine kinase (BTK) protein degraders or non covalent BTKi (ncBTKi). Patients who discontinue cBTKi due solely to toxicity are not eligible
- History of known bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention.
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- New Zealand
- China
- Switzerland
- Argentina
- Puerto Rico
- Australia
- Japan
- United Kingdom
- United States
- Brazil
- Singapore
- Israel
- Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; New Zealand; China; Switzerland; Argentina; Puerto Rico and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.