Study on Zanubrutinib and Rituximab for Treating Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT04458610
This clinical trial is testing how well the combination of zanubrutinib and rituximab works in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have not received any previous treatment. The study aims to see if these drugs can help control the disease.
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Program Overview
This study is exploring the effectiveness of two drugs, zanubrutinib and rituximab, in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not been treated before. Zanubrutinib may help stop cancer cells from growing by blocking certain enzymes, while rituximab is an antibody that may prevent cancer cells from growing and spreading. The goal is to find out if this combination can effectively manage these conditions.
Description
The main goal of this study is to see how many patients remain in remission, without needing treatment, six months after stopping zanubrutinib. Researchers also want to identify factors that contribute to a longer remission period and evaluate the effectiveness of re-treatment with zanubrutinib and rituximab if the disease returns.
Treatment Plan:
- Initial Treatment: Patients will take zanubrutinib pills twice a day and receive rituximab through an IV on specific days during the first cycle. This treatment cycle repeats every 28 days for up to 6 cycles, as long as the disease does not progress and side effects are manageable.
- Continued Treatment: Starting from cycle 7, patients who show a complete response will continue taking zanubrutinib for up to 6 more cycles. Those with partial response or stable disease will continue with both drugs for up to 6 more cycles. From cycle 13, patients with complete response will continue zanubrutinib for up to 6 more cycles, while those with partial response or stable disease will continue for up to 12 more cycles.
- Re-treatment for Relapse: If the disease returns, patients may restart the treatment with zanubrutinib and rituximab for up to 6 cycles, followed by zanubrutinib alone for up to 18 more cycles if needed.
After finishing the study treatment, patients will have follow-up visits at 60 days, then every 120 days for up to 5 years or until the disease progresses or a new treatment starts.
Eligibility Criteria
Inclusion Criteria
- Must have a diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and have not been treated before.
- Must meet specific criteria for needing treatment as per 2018 guidelines.
- Must understand and agree to the study, and be able to follow study procedures.
- Must have a performance status score of 0-2, indicating good overall health.
- Women of childbearing potential must agree to use effective birth control during the study and for 30 days after the last dose.
- Must have normal liver and kidney function as indicated by specific blood tests.
- Must be free of other cancers for 3 years, with some exceptions for certain skin or cervical cancers.
- Women of childbearing potential must have a negative pregnancy test before starting the study.
Exclusion Criteria
- Pregnant or breastfeeding women.
- Previous treatment with zanubrutinib or similar drugs.
- Previous treatment for CLL, including chemotherapy or immunotherapy, within 21 days before the study.
- Recent use of investigational drugs within 30 days before the study.
- Uncontrolled infections or serious health conditions.
- Severe blood disorders or organ dysfunction.
- Significant heart disease or recent heart attack.
- Recent stroke or bleeding disorders.
- Recent major surgery or serious injuries.
- Use of certain blood thinners like warfarin.
- Active hepatitis B or C, or HIV infection.
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