Phase II Study of Nemtabrutinib With Venetoclax and Obinutuzumab in Patients With Chronic Lymphocytic Leukemia
Medical College of Wisconsin
Summary
This is a single-arm, open-label Phase 2 study designed to evaluate the treatment outcomes of nemtabrutinib-venetoclax-obinutuzumab as a frontline management for chronic lymphocytic leukemia (CLL).
Description
The primary objective of this study is to determine the rate of undetectable minimal residual disease (MRD) with this therapy. Secondary objectives include assessment of response, adverse event profile, and survival. Patients with treatment-naïve CLL who meet the eligibility criteria would be initiated on treatment as described below. Patients will start nemtabrutinib monotherapy for the first 3 cycles, followed by the addition of obinutuzumab for 6 cycles (during Cycles 4-9) and venetoclax for 12 cycles (during Cycles 4-15) while continuing nemtabrutinib, for a total duration of 15 cycles of…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients aged 18 years or older. * Patients must have a diagnosis of CLL/ Small Lymphocytic Lymphoma (SLL) * Patients must meet International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for treatment initiation. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Patient must meet the following screening clinical laboratory values as specified below: * Hematologic: Absolute Neutrophil Count (ANC) of at least 1000 and platelet count of at least 50,000 unless these blood counts are low due to bone marrow involvement by CLL/SLL (use of g…
Interventions
- DrugNemtabrutinib
45 mg daily for 15 28-day cycles.
- DrugVenetoclax
Cycle 4, Days 1-7: 20 mg; Cycle 4, Days 8-14: 50 mg; Cycle 4, Days 15-21: 100 mg; Cycle 4, Days 22-28: 200 mg; Cycle 5-15: 400 mg.
- DrugObinutuzumab
Cycle 4, Day 1: 100 mg; Cycle 4, Day 2: 900 mg; Cycle 4, Day 8: 1000 mg; Cycle 4, Day 15: 1000 mg; Cycles 5-9, Day 1: 1000 mg.
Location
- Froedtert & the Medical College of WisconsinMilwaukee, Wisconsin