A Phase Two Study of Venetoclax Plus Zanubrutinib in Newly Diagnosed CLL and After Front-Line Time-Limited Venetoclax-Based Therapy
Kerry Rogers
Summary
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.
Description
PRIMARY OBJECTIVE: I. To determine undetectable minimal residual disease (uMRD) rates in CLL patients receiving fixed-duration combined treatment with venetoclax plus zanubrutinib. SECONDARY OBJECTIVES: I. Overall response rate. (Frontline Cohort) II. Rate of complete remission. (Frontline Cohort) III. Duration of response. (Frontline Cohort) IV. Duration of uMRD if achieved. (Frontline Cohort) V. Time to next treatment. (Frontline Cohort) VI. Rate of adverse events with zanubrutinib and venetoclax treatment. (Frontline Cohort) VII. Overall response rate. (Second Line Cohort) VIII. Rate of…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Frontline cohort: * CLL/SLL who are treatment-naïve and have met criteria 1 through 3 above * Second line cohort: * Must have received time-limited venetoclax based therapy in the front line. This is defined as treatment with venetoclax and an-anti-CD20 antibody, venetoclax and a BTKi, or t…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureBone Marrow Aspiration
Undergo bone marrow biopsy and aspiration
- ProcedureBone Marrow Biopsy
Undergo bone marrow biopsy and aspiration
- ProcedureComputed Tomography
Undergo CT
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- DrugVenetoclax
Given PO
- DrugZanubrutinib
Location
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio