A Phase 2 Study of Nemtabrutinib and Venetoclax as Frontline Treatment for Chronic Lymphocytic Leukemia (CLL)
Jennifer Woyach
Summary
This phase II trial tests how well nemtabrutinib and venetoclax work in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Nemtabrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cells (a type of white blood cell) in cancers such as CLL or SLL at abnormal levels. This may help keep cancer cells from growing and spreading. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Giving nemtabrutinib in combination with venetoclax may kill more cancer cells in patients with CLL or SLL.
Description
PRIMARY OBJECTIVE: I. To determine rates of undetectable minimal residual disease (MRD) (threshold 10\^-6) in the peripheral blood using adaptive ClonoSeq next generation sequencing (NGS) following 14 cycles of therapy with nemtabrutinib plus venetoclax in patients with treatment-naïve CLL/SLL. SECONDARY OBJECTIVES: I. To determine safety and toxicity profile for patients treated with the combination of nemtabrutinib plus venetoclax for treatment-naïve CLL/SLL. II. To determine progression free survival (PFS) for patients treated with the combination of nemtabrutinib plus venetoclax for tr…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Confirmed diagnosis of CLL/SLL meeting criteria established in the 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines * Is an individual of any sex/gender, who is at least 18 years of age on the day of signing informed consent * Participants must have treatment-naïve CLL/SLL. Palliative loco-regional radiotherapy, rituximab for autoimmune conditions, or corticosteroids for symptom control will not be considered prior therapy * Participants must meet criteria for treatment as defined by 2018 iwCLL guidelines which includes at least one of the f…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureBone Marrow Aspiration
Undergo bone marrow aspiration and biopsy
- ProcedureBone Marrow Biopsy
Undergo bone marrow aspiration and biopsy
- ProcedureComputed Tomography
Undergo CT
- DrugNemtabrutinib
Given PO
- OtherQuestionnaire Administration
Ancillary studies
- DrugVenetoclax
Location
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio