M.D. Anderson Cancer Center
This is an open-label, single-arm, phase II study which will assess the safety and efficacy of BGB16673 in combination with sonrotoclax as a time-limited approach for participants with treatment-naive CLL/SLL.
Primary Objective: 1\. To evaluate the therapeutic activity (undetectable measurable residual disease \[U-MRD\] rate at 10-4 sensitivity) of the combination of the BTK degrader BGB-16673 and sonrotoclax in patients with previously untreated CLL/SLL Secondary Objectives: 1. To evaluate the therapeutic activity of the combination of BTK degrader BGB-16673 and sonrotoclax by determining the overall response rate (defined as complete remission/complete remission with incomplete count recovery/partial remission \[CR/CRi/PR\]) 2. To evaluate progression free survival (PFS) 3. To evaluate overall…
Inclusion Criteria: 1. Patients with a diagnosis of previously untreated CLL/SLL meeting iwCLL 2018 indication for treatment (Note: patients who receive steroids and/or CD20 monoclonal antibody for cytoreduction in those patients presenting with significantly elevated WBC count or significant adenopathy/organomegaly and those who previously received steroids/CD20 monoclonal antibody for immune cytopenias are eligible to enroll; Washout of 4 weeks applies for CD20 monoclonal antibody and dose of prednisone (or equivalent) should be less than 20mg/day by day 1 of study initiation) 2. Age ≥ 18 y…
Given by mouth
Given by mouth
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