Study on Zanubrutinib and Venetoclax for Treating Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Sponsor: Dana-Farber Cancer Institute
ClinicalTrials ID:NCT05168930
This clinical trial is testing a combination of two drugs, zanubrutinib and venetoclax, to see if they are effective in treating patients with CLL or SLL who have already received treatment before.
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Program Overview
The purpose of this study is to evaluate how well the combination of zanubrutinib and venetoclax works in adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have had a relapse after previous treatments. Participants will receive the study drugs for 15 months, with an option for an additional 12 months if the disease returns. The study will follow participants for 36 months after they stop taking the study drugs. Up to 45 participants will be enrolled in this trial, which is funded by BeiGene Ltd.
Description
This study is an open-label, non-randomized phase 2 trial, meaning all participants will know what treatment they are receiving, and there is no comparison group. The trial is designed to assess the effectiveness of combining zanubrutinib and venetoclax in treating adults with CLL or SLL who have experienced a relapse after at least one prior therapy. Participants will initially receive the study treatment for 15 months. If the disease comes back, there is an option for an additional 12 months of treatment. After stopping the study drugs, participants will be monitored for 36 months to track their health and any changes in their condition. The study aims to enroll up to 45 participants, and BeiGene Ltd. is providing the funding and the study drug zanubrutinib.
Eligibility Criteria
Exclusion Criteria
- Have a known BTK C481X mutation.
- For certain groups, have received prior treatment with both a BTK inhibitor and BCL-2 inhibitor.
- Have had any anti-cancer therapy within 2 weeks before starting the study, except for certain hormonal or corticosteroid therapies.
- Have had a prior stem cell transplant from a donor.
- Have known involvement of the central nervous system (CNS) with cancer.
- Are currently receiving other investigational treatments.
- Have a history of other cancers, unless treated and inactive for at least 2 years.
- Have received live vaccines within 4 weeks before starting the study.
- Have had a recent serious infection requiring IV antibiotics.
- Have known bleeding disorders or a history of significant bleeding events.
- Have had a stroke or major bleeding within 6 months before the study.
- Require certain blood thinners like warfarin.
- Need medications that strongly affect liver enzymes (CYP3A inhibitors or inducers).
- Have a history of HIV, active hepatitis B or C.
- Have allergies to similar drugs as zanubrutinib or venetoclax.
- Have psychiatric or social issues that would prevent following the study requirements.
- Are pregnant or breastfeeding.
- Have digestive issues that affect absorption or function.
- Have significant heart disease or recent heart events.
- Have any life-threatening illness or condition that could affect safety or trial integrity.
- Have active autoimmune anemia or thrombocytopenia.
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