A Study to Evaluate the Effect of Venetoclax on Participants Receiving a Covalent Bruton's Tyrosi… (NCT06524375) | Clinical Trial Compass
Active — Not RecruitingPhase 2
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
United States118 participantsStarted 2024-08-09
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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