A Study to Evaluate the Safety and Efficacy of Tacabrutideg (BGB-16673) Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Purpose
The purpose of this study is to evaluate the efficacy and safety of tacabrutideg 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
- Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm A: Tacabrutideg |
Participants will receive tacabrutideg orally. |
|
|
Active Comparator Arm B: Pirtobrutinib |
Participants will receive pirtobrutinib orally. |
|
Recruiting Locations
University of Alabama At Birmingham Hospital
Birmingham, Alabama 35294-0004
Birmingham, Alabama 35294-0004
Mayo Clinic Phoenix
Phoenix, Arizona 85054-4502
Phoenix, Arizona 85054-4502
Kaiser Permanente Southern California
Irvine, California 92618-3734
Irvine, California 92618-3734
University of California San Diego (Ucsd) Moores Cancer Center
La Jolla, California 92093-1503
La Jolla, California 92093-1503
Cancer and Blood Specialty Clinic
Los Alamitos, California 90720-3302
Los Alamitos, California 90720-3302
UCLA Department of Medicine Hematologyoncology
Los Angeles, California 90095-3075
Los Angeles, California 90095-3075
Kaiser Permanente Oakland Medical Center
Oakland, California 94611
Oakland, California 94611
Stanford Cancer Institute
Palo Alto, California 94304-2205
Palo Alto, California 94304-2205
Kaiser Permanente Roseville Medical Center
Roseville, California 95661
Roseville, California 95661
Kaiser Permanente San Francisco Medical Center Oncology
San Francisco, California 94115
San Francisco, California 94115
Kaiser Permanente Santa Clara Medical Center Oncologyhematology
Santa Clara, California 95051
Santa Clara, California 95051
Kaiser Permanente Northern California
Vallejo, California 94589-2441
Vallejo, California 94589-2441
Kaiser Permanente Walnut Creek Medical Center
Walnut Creek, California 94596
Walnut Creek, California 94596
Christiana Care
Newark, Delaware 19713-2055
Newark, Delaware 19713-2055
Medstar Georgetown University Hospital
Washington D.C., District of Columbia 20007-2113
Washington D.C., District of Columbia 20007-2113
Mayo Clinic Jacksonville
Jacksonville, Florida 32224-1865
Jacksonville, Florida 32224-1865
Cancer Specialists of North Florida
Jacksonville, Florida 32256
Jacksonville, Florida 32256
Mount Sinai Medical Center Braman Comprehensive Cancer Center
Miami, Florida 33140
Miami, Florida 33140
University of Chicago Medical Center
Chicago, Illinois 60637-1443
Chicago, Illinois 60637-1443
Mission Cancer and Blood
Waukee, Iowa 50263
Waukee, Iowa 50263
The University of Kansas Cancer Center
Westwood, Kansas 66205-2003
Westwood, Kansas 66205-2003
Our Lady of the Lake Hospital
Baton Rouge, Louisiana 70808-4365
Baton Rouge, Louisiana 70808-4365
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana 70809-3738
Baton Rouge, Louisiana 70809-3738
Ochsner Clinic Foundation
New Orleans, Louisiana 70121-2429
New Orleans, Louisiana 70121-2429
Dana Farber Cancer Institute
Boston, Massachusetts 02215-5418
Boston, Massachusetts 02215-5418
Karmanos Cancer Institute
Detroit, Michigan 48201-2013
Detroit, Michigan 48201-2013
Mayo Clinic Rochester
Rochester, Minnesota 55905-0001
Rochester, Minnesota 55905-0001
Washington University School of Medicine
St Louis, Missouri 63110-1010
St Louis, Missouri 63110-1010
Titan Health Partners Llc Dba Astera Cancer Care
East Brunswick, New Jersey 08816-4096
East Brunswick, New Jersey 08816-4096
John Theurer Cancer Center Hackensack University Medical Center
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
Columbia University Medical Center
New York, New York 10032
New York, New York 10032
Weill Cornell Medical College Newyork Presbyterian Hospital
New York, New York 10065-4870
New York, New York 10065-4870
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York 10065-6800
New York, New York 10065-6800
University of Rochester
Rochester, New York 14642-0001
Rochester, New York 14642-0001
University of North Carolina At Chapel Hill
Chapel Hill, North Carolina 27514-4220
Chapel Hill, North Carolina 27514-4220
Atrium Health Levine Cancer Institute (Lci)
Charlotte, North Carolina 28204-2990
Charlotte, North Carolina 28204-2990
Duke University Medical Center
Durham, North Carolina 27705-3976
Durham, North Carolina 27705-3976
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
Dayton Physician Network
Dayton, Ohio 45415
Dayton, Ohio 45415
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111-2434
Philadelphia, Pennsylvania 19111-2434
Tennessee Oncology, Pllc Nashville
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Md Anderson Cancer Center
Houston, Texas 77030-3907
Houston, Texas 77030-3907
Blue Ridge Cancer Care (Oncology and Hematology Associates of Southwest Virginia)
Roanake, Virginia 24014
Roanake, Virginia 24014
Fred Hutchinson Cancer Research Center
Seattle, Washington 98109-4433
Seattle, Washington 98109-4433
Summit Cancer Centers
Spokane, Washington 99208-1129
Spokane, Washington 99208-1129
Northwest Medical Specialties
Tacoma, Washington 98405
Tacoma, Washington 98405
Gunderson Health System
La Crosse, Wisconsin 54601-5467
La Crosse, Wisconsin 54601-5467
Auxilio Mutuo Cancer Center
San Juan, Puerto Rico 00917
San Juan, Puerto Rico 00917
More Details
- Status
- Recruiting
- Sponsor
- BeOne Medicines
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.