About this trial
This phase II trial tests the effect of venetoclax in combination with standard of care (SOC) zanubrutinib in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). 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. Zanubrutinib blocks a protein called Bruton tyrosine kinase (BTK), which may help keep cancer cells from growing. It is a type of tyrosine kinase inhibitor. Giving venetoclax in combination with SOC zanubrutinib may be safe and tolerable and may reduce the number of cancer cells that remain in the body in patients with CLL or SLL that have not previously received treatment or at least two years have passed since completing initial treatment.
Eligibility criteria
Qualifiers
Diagnosis of CLL/SLL meeting criteria established in International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria
Age ≥ 18 years
Indications for treatment as defined by the iwCLL 2018 Guidelines
Received prior treatment or not depending on cohort
Disqualifiers
Second line arm only: Patients who progressed per iwCLL 2018 criteria on therapy or within two years of completing time-limited, venetoclax based treatment
Frontline arm only: Patients with deletion 17p and/or TP53 mutation
Active Richter's transformation
Prior zanubrutinib exposure
Trial design
Treatments tested in this trial
- Biospecimen Collection
- Bone Marrow Aspiration
- Bone Marrow Biopsy
- Computed Tomography
- Magnetic Resonance Imaging
- Venetoclax
- Zanubrutinib
Treatment groups
Sponsors and collaborators
Kerry Rogers
Lead sponsor
Ohio State University Comprehensive Cancer Center
Sponsor institution
AbbVie
Collaborator