NCT06524375Active, not recruitingPhase 2
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
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
Source: ClinicalTrials.gov · Last updated 28 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 118 (actual)
- First submitted
- 23 Jul 2024
- Start date
- 9 Aug 2024
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- Genentech, Inc.
- Diseases
- Chronic lymphocytic leukaemia
- NCT number
- NCT06524375
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 118
- From 9 Aug 2024 to the primary completion date, 31 Oct 2026
- 20 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior B-cell lymphoma (Bcl-2) inhibitor therapy
- Anti-cluster of differentiation 20 (CD20) therapy within the month prior to screening
Other illness
- Progressive or stable disease on cBTKi
- 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
- Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
Other
- Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (Richter's transformation or pro-lymphocytic leukemia)
- Pregnant women and nursing mothers
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (20)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rocky Mountain Cancer Centers (Aurora) - USOR Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| American Oncology Partners of Maryland, PA Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
| Dana-Farber Cancer Institute - Hematologic Oncology Treatment Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Tennessee Oncology PLLC - Chattanooga Coordinator of this site? Confirm its status | Chattanooga | United States | Unknown status |
| Oncology Hematology Care Inc - Cincinnati - USOR Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Mission Blood and Cancer - MercyOne Cancer Center Coordinator of this site? Confirm its status | Des Moines | United States | Unknown status |
| Astera Cancer Care - East Brunswick Coordinator of this site? Confirm its status | East Brunswick | United States | Unknown status |
| Willamette Valley Cancer Institute and Research Center Coordinator of this site? Confirm its status | Eugene | United States | Unknown status |
| San Juan Oncology Associates, PC Coordinator of this site? Confirm its status | Farmington | United States | Unknown status |
| Fort Wayne Medical Oncology and Hematology, Inc Coordinator of this site? Confirm its status | Fort Wayne | United States | Unknown status |
| Nebraska Cancer Specialists St Francis - Grand Island Coordinator of this site? Confirm its status | Grand Island | United States | Unknown status |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Cancer Specialists of North Florida Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Asante Rogue Regional Medical Center Coordinator of this site? Confirm its status | Medford | United States | Unknown status |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Tennessee Oncology - Midtown Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Nebraska Cancer Specialists Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Highlands Oncology Group Coordinator of this site? Confirm its status | Springdale | United States | Unknown status |
| Texas Oncology - Northeast Texas Coordinator of this site? Confirm its status | Tyler | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.