Comparing a BTK-targeted protein degrader (BGB-16673) with pirtobrutinib for adults with relapsed or refractory CLL or SLL

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 Phase 3 randomized trial compares BGB-16673, a Bruton tyrosine kinase (BTK)–targeted protein degrader, with pirtobrutinib, a noncovalent BTK inhibitor, in adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after prior covalent BTK inhibitor therapy. Eligible participants are assigned to receive one of the two oral agents and are followed for response rates, safety, and duration of benefit. Key inclusion criteria require prior cBTKi exposure and, for SLL, measurable lymph nodes; key exclusions include Richter's transformation, certain bleeding disorders, recent stroke or intracranial hemorrhage, and prior exposure to BTK protein degraders. Primary and secondary endpoints focus on efficacy outcomes and safety measures typical of late-phase CLL trials.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Where it's running

• University of Alabama At Birmingham Hospital
  Birmingham, Alabama, United States Recruiting
• Mayo Clinic Phoenix
  Phoenix, Arizona, United States Recruiting
• Kaiser Permanente Southern California
  Irvine, California, United States Recruiting
• University of California San Diego (Ucsd) Moores Cancer Center
  La Jolla, California, United States Recruiting
• Cancer and Blood Specialty Clinic
  Los Alamitos, California, United States Recruiting
• UCLA Department of Medicine Hematologyoncology
  Los Angeles, California, United States Recruiting

+167 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Director
• Email: clinicaltrials@beonemed.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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• Pirtobrutinib versus ibrutinib for people with CLL or SLL.

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• Venetoclax plus Zanubrutinib for CLL/SLL in frontline or previously treated patients

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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.