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Purpose

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).

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: BGB-16673 		Participants will receive BGB-16673 orally.
  • Drug: BGB-16673
    BGB-16673 will be administered orally
Active Comparator
Arm B: Pirtobrutinib 		Participants will receive pirtobrutinib orally.
  • Drug: Pirtobrutinib
    Pirtobrutinib will be administered orally
    Other names:
    • Jaypirca

Recruiting Locations

Mayo Clinic Phoenix
Phoenix 5308655, Arizona 5551752 85054-4502

Stanford Cancer Institute
Palo Alto 5380748, California 5332921 94304-2205

Cancer Specialists of North Florida
Jacksonville 4160021, Florida 4155751 001625

Mayo Clinic Jacksonville
Jacksonville 4160021, Florida 4155751 32224-1865

Mount Sinai Comprehensive Cancer Center
Miami Beach 4164143, Florida 4155751 33140-2840

Mary Bird Perkins Cancer Center
Baton Rouge 4315588, Louisiana 4331987 70809-3738

Ochsner Clinic Foundation
New Orleans 4335045, Louisiana 4331987 70121-2429

Karmanos Cancer Institute
Detroit 4990729, Michigan 5001836 48201-2013

Mayo Clinic Rochester
Rochester 5043473, Minnesota 5037779 55905-0001

Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110-1010

Titan Health Partners Llc Dba Astera Cancer Care
East Brunswick 5097402, New Jersey 5101760 08816-4096

Memorial Sloan Kettering Cancer Center Mskcc
New York 5128581, New York 5128638 10065-6800

University of Rochester
Rochester 5134086, New York 5128638 14642-0001

University of North Carolina At Chapel Hill
Chapel Hill 4460162, North Carolina 4482348 27514-4220

Atrium Health Levine Cancer Institute (Lci)
Charlotte 4460243, North Carolina 4482348 28204-2990

Duke University Medical Center
Durham 4464368, North Carolina 4482348 27705-3976

Dayton Physician Network
Dayton 4509884, Ohio 5165418 45415

Tennessee Oncology, Pllc Nashville
Nashville 4644585, Tennessee 4662168 37203

Blue Ridge Cancer Care (Oncology and Hematology Associates of Southwest Virginia)
Roanoke 4782167, Virginia 6254928 24014

Fred Hutchinson Cancer Research Center
Seattle 5809844, Washington 5815135 98109-4433

Summit Cancer Centers
Spokane 5811696, Washington 5815135 99208-1129

Northwest Medical Specialties
Tacoma 5812944, Washington 5815135 98405

Gunderson Health System
La Crosse 5258957, Wisconsin 5279468 54601-5467

Auxilio Mutuo Cancer Center
San Juan 4568127, Puerto Rico 00917

More Details

Status
Recruiting
Sponsor
BeOne Medicines

Study Contact

Study Director
1-877-828-5568
clinicaltrials@beonemed.com

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.