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

Description

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.

Trial Eligibility

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. Progressive or stable disease on cBTKi 3. Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (Richter's transformation or pro-lymphocytic leukemia) 4. History of cardiomyopathy 5. Hypersensitivity to venetoclax or to any of the excipients (e.g., trehalose) 6. Clinically significant cardiovascular disease 7. Active bleeding or history of bleeding diathesis 8. Pregnant women and nursing mothers 9. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia

Study Info

Interventions

Locations Recruiting

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