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A Study of BGB-16673 vs. Pirtobrutinib for Relapsed/Refractory CLL/SLL

This study is looking at two oral medications, BGB-16673 and pirtobrutinib, for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). These are types of cancer affecting white blood cells. You may be able to join if your CLL or SLL has come back or hasn't responded to previous treatments, especially if you've already had a type of medication called a covalent Bruton tyrosine kinase inhibitor (cBTKi). Both BGB-16673 and pirtobrutinib work by targeting specific proteins (kinases, tyrosine kinase) involved in cancer growth. The main goal is to see how long people live without their cancer getting worse, which will be checked for up to about three years. The study plans to enroll about 500 participants.

Study design
This is an interventional study comparing BGB-16673 to pirtobrutinib in approximately 500 adult participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for progression-free survival for up to approximately 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06973187

A Study to Evaluate the Safety and Efficacy of Tacabrutideg (BGB-16673) Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Recruiting
PHASE3Ages 18+InterventionalTreatment
BeOne Medicines
~500 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:TacabrutidegPirtobrutinib

At a glance

Recruiting sites
209 of 209 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (PFS) per Independent Review Committee (IRC)
Measured over Up to approximately 3 years

Conditions

Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma

Explore related trials

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

Where it's being run

209 sites across 87 states
California11
Germany9
France8
Poland8
Belgium7
Brazil7
Israel7
Spain7

Study leadership

  • Study Director · STUDY_DIRECTOR · BeOne Medicines

Who to contact

Study Director
[email protected]
1-877-828-5568
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
Participants 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.

Exclusion

Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation.
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
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 noncovalent Bruton tyrosine kinase inhibitor (ncBTKi).
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

What this trial measures

  • Progression-Free Survival (PFS) per Independent Review Committee (IRC)Up to approximately 3 years

    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).