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.
Principal investigator
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 (\
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
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
Participate in this trial
Are you interested in enrolling in this study? Learn more here.
I'm Interested In ParticipatingFor Referring Providers
Do you have a patient you think would be a good candidate for this trial? Learn more about enrolling your patient.