RecruitingInterventionalPhase 3

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

NCT ID: NCT06973187Sponsor: BeOne MedicinesLast updated: 2026-06-18

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).

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.

Arms & interventions

DrugBGB-16673
BGB-16673 will be administered orally
DrugPirtobrutinib
Pirtobrutinib will be administered orally

Outcome measures

Primary

Progression-Free Survival (PFS) per Independent Review Committee (IRC)
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).
Time frame: Up to approximately 3 years

Secondary

Overall Survival (OS)
Time frame: Up to approximately 3 years
PFS per Investigator (INV)
Time frame: Up to approximately 3 years
Overall Response Rate (ORR) per IRC and INV
Time frame: Up to approximately 3 years
Rate of Partial Response with Lymphocytosis (PR-L) or Higher per IRC and INV
Time frame: Up to approximately 3 years
Duration of Response (DOR) per IRC and INV
Time frame: Up to approximately 3 years
Time to Next Anti-CLL/SLL Treatment (TTNT)
Time frame: Up to approximately 3 years
Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately 3 years
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire EORTC IL409
Time frame: Baseline and up to approximately 3 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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 locations (37)

University of Alabama At Birmingham Hospital

Birmingham, Alabama, 35294-0004

Recruiting

Mayo Clinic Phoenix

Phoenix, Arizona, 85054-4502

Recruiting

Kaiser Permanente Southern California

Irvine, California, 92618-3734

Recruiting

University of California San Diego (Ucsd) Moores Cancer Center

La Jolla, California, 92093-1503

Recruiting

Cancer and Blood Specialty Clinic

Los Alamitos, California, 90720-3302

Recruiting

UCLA Department of Medicine Hematologyoncology

Los Angeles, California, 90095-3075

Recruiting

Stanford Cancer Institute

Palo Alto, California, 94304-2205

Recruiting

Christiana Care

Newark, Delaware, 19713-2055

Recruiting

Cancer Specialists of North Florida

Jacksonville, Florida, 001625

Recruiting

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224-1865

Recruiting

Mount Sinai Medical Center Braman Comprehensive Cancer Center

Miami, Florida, 33140

Recruiting

University of Chicago Medical Center

Chicago, Illinois, 60637-1443

Recruiting

The University of Kansas Cancer Center

Westwood, Kansas, 66205-2003

Recruiting

Our Lady of the Lake Hospital

Baton Rouge, Louisiana, 70808-4365

Recruiting

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809-3738

Recruiting

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121-2429

Recruiting

Dana Farber Cancer Institute

Boston, Massachusetts, 02215-5418

Recruiting

Karmanos Cancer Institute

Detroit, Michigan, 48201-2013

Recruiting

Mayo Clinic Rochester

Rochester, Minnesota, 55905-0001

Recruiting

Washington University School of Medicine

St Louis, Missouri, 63110-1010

Recruiting

Titan Health Partners Llc Dba Astera Cancer Care

East Brunswick, New Jersey, 08816-4096

Recruiting

John Theurer Cancer Center Hackensack University Medical Center

Hackensack, New Jersey, 07601

Recruiting

Columbia University Medical Center

New York, New York, 10032

Recruiting

Memorial Sloan Kettering Cancer Center Mskcc

New York, New York, 10065-6800

Recruiting

University of Rochester

Rochester, New York, 14642-0001

Recruiting

University of North Carolina At Chapel Hill

Chapel Hill, North Carolina, 27514-4220

Recruiting

Atrium Health Levine Cancer Institute (Lci)

Charlotte, North Carolina, 28204-2990

Recruiting

Duke University Medical Center

Durham, North Carolina, 27705-3976

Recruiting

Dayton Physician Network

Dayton, Ohio, 45415

Recruiting

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2434

Recruiting

Tennessee Oncology, Pllc Nashville

Nashville, Tennessee, 37203

Recruiting

Md Anderson Cancer Center

Houston, Texas, 77030-3907

Recruiting

Blue Ridge Cancer Care (Oncology and Hematology Associates of Southwest Virginia)

Roanoke, Virginia, 24014

Recruiting

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-4433

Recruiting

Summit Cancer Centers

Spokane, Washington, 99208-1129

Recruiting

Northwest Medical Specialties

Tacoma, Washington, 98405

Recruiting

Gunderson Health System

La Crosse, Wisconsin, 54601-5467

Recruiting