At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Diagnosis of CLL or SLL according to WHO criteria
- ✓For SLL patients, peripheral blood flow cytometry must be positive with CLL-like cells ≥1% of circulating WBC
- ✓Untreated CLL or SLL (for CLL cohort)
- ✕Active histological transformation (Richter's transformation)
- ✕Active malignancy or systemic therapy for another malignancy within 3 years
- ✕Other diagnosis of active cancer
- ✕Uncontrolled illness precluding study therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 2 Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) and Mantle Cell Lymphoma (MCL)
In Brief
A Phase 2 clinical trial evaluating Zanubrutinib, Obinutuzumab, and 1 other intervention for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Leukemia (SLL). Currently recruiting, targeting 230 participants across 8 sites.
Signals
Detailed Summary
The purpose of this study is to determine the rate of minimum residual disease (MRD) negative response (i.e. the rate of no evidence of disease) of the study drugs, zanubrutinib, obinutuzumab, and venetoclax, given in combination as a treatment for CLL and/or SLL.
Study Details
Timeline
Interventions
zanubrutinib (160mg by mouth BID)
obinutuzumab (1000mg IVPB on Days 1\*, 8 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 8) starting on Cycle 1 (28-day cycles). \* On Cycle 1, obinituzumab will be administered in "split dose" at 100mg IVPB on Day 1 and 900mg IVPB on Day 2 in patients at increased risk for IRR (ALC \>25,000 cells/ul or baseline lymph nodes \>5 cm diameter).
Venetoclax will be added to the regimen starting on Cycle 3, and will be incorporated into the regimen using the 5-week ramp-up schedule to mitigate the risk of tumor lysis syndrome (beginning at 20mg and gradually increasing to 400mg), and venetoclax will be administered a ta fixed dose level of 400mg by mouth daily of 28-day cycles thereafter.