A Phase 2 Trial Of The Combination Of Zanubrutinib, Sonrotoclax, And Obinutuzumab For Patients With Treatment-Naïve Chronic Lymphocytic Leukemia
brief summary
The goal of this clinical research study is to learn if the combination of zanubrutinib, sonrotoclax, and obinutuzumab can help to control previously untreated CLL/SLL.
detailed description
Primary Objective:
1\. To evaluate the therapeutic activity, measured by U-MRD4 rate (assessed by clonoSEQ assay) in the bone marrow after cycle 15 of the combination of zanubrutinib, sonrotoclax, and obinutuzumab in patients with previously untreated CLL/SLL.
Secondary Objectives:
1. To evaluate the therapeutic activity of the combination of zanubrutinib, sonrotoclax, and obinutuzumab by determining the overall response rate (defined as CR/CRi/PR) and U-MRD5/UMRD6 rate. 2. To evaluate progression free survival (PFS). 3. To evaluate overall survival (OS). 4. To determine the safety and tolerability of the combination of zanubrutinib, sonrotoclax, and obinutuzumab. 5. To determine the U-MRD4 rate, PFS, and OS in patients with unmutated IGHV, del(17p) and/or TP53 mutation 6. To determine time to next treatment after discontinuation of combination of zanubrutinib, sonrotoclax, and obinutuzumab. 7. To determine time to achievement of U-MRD4 with the combination of zanubrutinib, sonrotoclax, and obinutuzumab. 8. To determine the rate of U-MRD4 conversion (achievement of U-MRD4 from detectable MRD) with the addition of obinutuzumab from cycle 10 in patients who had detectable MRD4 in bone marrow or peripheral blood at the end of cycle 9.
Exploratory Objectives:
1. To study immunological and molecular changes in the peripheral blood and bone marrow in response to zanubrutinib, sonrotoclax, and obinutuzumab 2. To evaluate the kinetics of MRD response over time