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.
NCT ID: NCT06524375
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
110 participants
INTERVENTIONAL
2024-08-09
2028-02-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The acronym BRAVE stands for Btki Responders to Achieve deep remission (or off-treatment periods) with VEnetoclax.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Venetoclax as Consolidation in CLL Patients Treated With BTK Inhibitor Monotherapy
NCT06958705
A Study of Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
NCT02966756
A Randomized Phase II Study Of Bruton Tyrosine Kinase Inhibitor With Or Without Venetoclax In Veterans With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
NCT06520098
Pirtobrutinib (LOXO-305) and Venetoclax for the Treatment of Patients With CLL or SLL Resistant to Covalent BTKi
NCT06466122
Trial of Ibrutinib Plus Venetoclax Plus Obinutuzumab in Patients With CLL
NCT02758665
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Venetoclax Added to cBTKi (Commercially Prescribed)
Participants will receive venetoclax, orally, once daily (QD) with a starting ramp-up dose of 20 milligrams (mg) on Day 1 of Cycle 1 (cycle length= 28 days). The dose will increase weekly; thereafter, treatment will continue with venetoclax at the target dose of 400 mg, QD from Day 1 of Cycle 2 up to Day 28 of Cycle 12.
Participants will continue receiving cBTKi-monotherapy (i.e. ibrutinib or acalabrutinib, or zanubrutinib) as previously prescribed by the investigator according to the prescribing label.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to (\</=) 2
3. Adequate renal and liver function
Exclusion Criteria
2. Anti-cluster of differentiation 20 (CD20) therapy within the month prior to screening
3. Progressive or stable disease on cBTKi
4. Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (Richter's transformation or pro-lymphocytic leukemia)
5. History of cardiomyopathy
6. Hypersensitivity to venetoclax or to any of the excipients (e.g., trehalose)
7. Clinically significant cardiovascular disease
8. Active bleeding or history of bleeding diathesis
9. Pregnant women and nursing mothers
10. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Genentech, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
University Cancer & Blood Center, LLC
Athens, Georgia, 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
Oncology Associates of Oregon, P.C.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Reference Study ID Number: ML45219 https://forpatients.roche.com/
Role: CONTACT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ML45219
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.