Nemtabrutinib and Venetoclax for the Treatment of Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJennifer Woyach
About this trial
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.
Eligibility criteria
Qualifiers
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
Massive (>= 6 cm below the costal margin), progressive or symptomatic splenomegaly
Disqualifiers
Subject with other malignancies that are associated with a life expectancy of < 2 years or that would confound assessment of toxicity in this study.
NOTE: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder
Clinically significant cardiovascular disease such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification. Note: Subjects with controlled atrial fibrillation can enroll on study
Active HBV/HCV infection
Trial design
Treatments tested in this trial
- Biospecimen Collection
- Bone Marrow Aspiration
- Bone Marrow Biopsy
- Computed Tomography
- Nemtabrutinib
- Questionnaire Administration
- Venetoclax
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
Jennifer Woyach
Lead sponsor
Ohio State University Comprehensive Cancer Center
Sponsor institution
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov