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.

Launched by GENENTECH, INC. · Jul 23, 2024

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ClinConnect Summary

This clinical trial, called the BRAVE study, is investigating whether adding a medication called venetoclax to a current treatment can help people with Chronic Lymphocytic Leukemia (CLL) achieve a deeper and longer-lasting remission. The goal is to see if participants can reach a state where the disease is so low that it's undetectable or very minimal in their blood by the end of the combined treatment. This could potentially allow them to take a break from treatment altogether.

To join the study, participants must be diagnosed with CLL and have been on a stable dose of a specific type of medication known as a covalent Bruton's Tyrosine Kinase inhibitor (like ibrutinib, acalabrutinib, or zanubrutinib) for at least six months. They should also be in good overall health and not have had certain other health issues or previous treatments that could complicate their participation. Throughout the trial, participants will receive regular check-ups and monitoring to understand how the treatment is affecting their condition. This study is currently looking for participants aged 65 to 74, and it welcomes individuals of any gender.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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
• • 2. Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to (\</=) 2
• • 3. Adequate renal and liver function
• Exclusion Criteria:
• • 1. Prior B-cell lymphoma (Bcl-2) inhibitor therapy
• • 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