Study on the Safety and Effectiveness of BGB-16673 Compared to Pirtobrutinib in Adults with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Sponsor: BeOne Medicines

Sponsor score: 0

ClinicalTrials ID:NCT06973187

This clinical trial is testing a new drug, BGB-16673, to see if it is safe and effective compared to another drug, pirtobrutinib, in adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

The aim of this study is to compare the effectiveness and safety of a new treatment, BGB-16673, with an existing treatment, pirtobrutinib, in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has come back or not responded to previous treatments. Participants must have previously been treated with a specific type of medication called a covalent Bruton tyrosine kinase inhibitor (cBTKi).

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that requires treatment.
  • Have previously been treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi) and have the disease return or not respond to at least one line of therapy, including a cBTKi.
  • For those with SLL, have measurable disease on scans, with at least one lymph node larger than 1.5 cm in diameter.

Exclusion Criteria

  • Have a known type of leukemia called prolymphocytic leukemia or a history of, or currently suspected, transformation to a more aggressive form known as Richter's transformation.
  • Have a history of bleeding disorders like hemophilia or von Willebrand disease, or have experienced spontaneous bleeding that required medical treatment.
  • Have had a stroke or bleeding in the brain within the last 6 months.
  • Have previously been treated with any Bruton tyrosine kinase (BTK) protein degraders or noncovalent Bruton tyrosine kinase inhibitors (ncBTKi).
  • Have current or past involvement of the central nervous system (brain, spinal cord, or surrounding areas) by CLL/SLL, as shown by imaging or tests.

Locations

FACILITYZIPCITYSTATE
Cancer Specialists of North Florida001625JacksonvilleFlorida
Washington University School of Medicine63110-1010St LouisMissouri
Dayton Physician Network45415DaytonOhio
Blue Ridge Cancer Care (Oncology and Hematology Associates of Southwest Virginia)24014RoanokeVirginia
Summit Cancer Centers99208-1129SpokaneWashington
Northwest Medical Specialties98405TacomaWashington

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