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.
ClinicalTrials ID:NCT06524375
The BRAVE study assesses venetoclax addition to cBTKi in 1L CLL patients to achieve uMRD. Eligible participants must have stable cBTKi treatment for 6+ months, ECOG ≤2, and adequate organ function. Interventions include venetoclax tablets and cBTKi monotherapy, following respective dosing schedules.
Patient Parameters
| Parameter | Options |
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Program Overview
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Prior B-cell lymphoma (Bcl-2) inhibitor therapy
- 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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Highlands Oncology Group | 72762 | Springdale | Arkansas |
| Rocky Mountain Cancer Centers (Aurora) - USOR | 80012-5405 | Aurora | Colorado |
| University Cancer & Blood Center, LLC | 30607 | Athens | Georgia |
| Fort Wayne Medical Oncology and Hematology, Inc | 46804 | Fort Wayne | Indiana |
| Mission Blood and Cancer - MercyOne Cancer Center | 50314-3030 | Des Moines | Iowa |
| American Oncology Partners of Maryland, PA | 20817-1915 | Bethesda | Maryland |
| Dana Farber Cancer Inst. | 02115 | Boston | Massachusetts |
| Nebraska Cancer Specialists St Francis - Grand Island | 68803 | Grand Island | Nebraska |
| Nebraska Cancer Specialists | 68130-2042 | Omaha | Nebraska |
| Astera Cancer Care East Brunswick | 08816-4096 | East Brunswick | New Jersey |
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