Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSD
Dates
study started
study ends around

Description

Summary

The purpose of this study is to evaluate the efficacy and safety of BGB-16673 alone compared with pirtobrutinib in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had been previously treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi).

Official Title

A Phase 3, Open-Label, Randomized 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

Details

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Keywords

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Noncovalent Bruton tyrosine kinase inhibitor, Bruton tyrosine kinase-targeted protein degrader, Leukemia, Lymphocytic, Chronic, B-Cell, pirtobrutinib, BGB-16673

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • University of California San Diego (Ucsd) Moores Cancer Center accepting new patients
    La Jolla California 92093-1503 United States
  • UCLA Department of Medicine Hematologyoncology accepting new patients
    Los Angeles California 90095-3075 United States
  • Stanford Cancer Institute accepting new patients
    Palo Alto California 94304-2205 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
BeOne Medicines
ID
NCT06973187
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 500 study participants
Last Updated