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A Study to Evaluate the Effect of Venetoclax on Participants Receiving a Covalent Bruton's Tyrosine Kinase Inhibitor (cBTKi) for First-line Chronic Lymphocytic Leukemia (1L CLL) to Achieve Deep Durable Remissions to Allow Off-treatment Period
Sponsor: Genentech, Inc.
Summary
The main purpose of the study is to evaluate if adding venetoclax to participants receiving cBTKi for the 1L CLL can achieve deep durable remissions of undetectable measurable residual disease \[uMRD \< or 10\^-4 in peripheral blood (PB)\] by end of combination treatment (EOCT) to allow off-treatment period. The acronym BRAVE stands for Btki Responders to Achieve deep remission (or off-treatment periods) with VEnetoclax.
Official title: Phase II, Open-label, Prospective Single-arm, Multi-center Clinical Trial to Evaluate if Adding Venetoclax to Patients on Covalent BTKi For 1L CLL Can Achieve Deep Durable Remissions (by UMRD 10^-4) to Allow Off-treatment Period
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
118
Start Date
2024-08-09
Completion Date
2030-01-31
Last Updated
2026-02-25
Healthy Volunteers
No
Conditions
Interventions
Venetoclax
Venetoclax tablets will be administered as per the schedule specified in the arm.
cBTKi Monotherapy
Commercially available cBTKi (ibrutinib or acalabrutinib, or zanubrutinib) will be administered in accordance with its prescribing label.
Locations (20)
Highlands Oncology Group
Springdale, Arkansas, United States
Rocky Mountain Cancer Centers (Aurora) - USOR
Aurora, Colorado, United States
Cancer Specialists of North Florida
Jacksonville, Florida, United States
Fort Wayne Medical Oncology and Hematology, Inc
Fort Wayne, Indiana, United States
Mission Blood and Cancer - MercyOne Cancer Center
Des Moines, Iowa, United States
American Oncology Partners of Maryland, PA
Bethesda, Maryland, United States
Dana-Farber Cancer Institute - Hematologic Oncology Treatment Center
Boston, Massachusetts, United States
Nebraska Cancer Specialists St Francis - Grand Island
Grand Island, Nebraska, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Astera Cancer Care East Brunswick
East Brunswick, New Jersey, United States
San Juan Oncology Associates, PC
Farmington, New Mexico, United States
Oncology Hematology Care Inc - Cincinnati - USOR
Cincinnati, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States
Asante Rogue Regional Medical Center
Medford, Oregon, United States
Tennessee Oncology, PLLC - Chattanooga
Chattanooga, Tennessee, United States
Tennessee Oncology - Midtown
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Texas Oncology- Northeast Texas
Tyler, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States