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
Running, not enrolling · Phase 2
Conditions studied: Chronic Lymphocytic Leukemia
In brief
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.
Key facts
- Study ID
- NCT06524375
- Run by
- Genentech, Inc.
- People needed
- 118
- Starts
- 2024-08-09
- Expected to finish
- 2030-01-31
- Last updated by the study team
- 2026-02-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosed with CLL and currently receiving a stable dose of cBTKi (i.e., ibrutinib, acalabrutinib, or zanubrutinib) for at least 6 months for 1L treatment with a response of at least a PR per iwCLL criteria
- Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to (</=) 2
- Adequate renal and liver function
You may not qualify if…
- Prior B-cell lymphoma (Bcl-2) inhibitor therapy
- Anti-cluster of differentiation 20 (CD20) therapy within the month prior to screening
- Progressive or stable disease on cBTKi
- Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (Richter's transformation or pro-lymphocytic leukemia)
- History of cardiomyopathy
- Hypersensitivity to venetoclax or to any of the excipients (e.g., trehalose)
- Clinically significant cardiovascular disease
- Active bleeding or history of bleeding diathesis
- Pregnant women and nursing mothers
- Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
Where it is running
- 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
Full record on ClinicalTrials.gov
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