Study on Rituximab and Zanubrutinib for Patients with Slow-Growing B-cell Lymphomas
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor score: 40
ClinicalTrials ID:NCT06350318
This clinical trial is testing the safety and effectiveness of combining two drugs, rituximab and zanubrutinib, for treating patients with certain types of untreated B-cell lymphomas, specifically marginal zone lymphoma and follicular lymphoma.
Patient Parameters
| Parameter | Options |
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Program Overview
The aim of this study is to determine if the combination of rituximab and zanubrutinib is safe and effective for people with untreated B-cell lymphomas, such as marginal zone lymphoma (MZL) and follicular lymphoma (FL).
Eligibility Criteria
Inclusion Criteria
- Patients with untreated marginal zone lymphoma (MZL) or follicular lymphoma (FL).
- Must have a confirmed diagnosis of MZL or FL, with available tissue samples for confirmation.
- MZL patients must require systemic treatment and can include nodal, splenic, or extra-nodal types.
- FL patients must have a pathological grade of 1, 2, or 3a.
- Disease must require systemic therapy, not just local radiation.
- Must have measurable disease, meaning a tumor or lymph node that is at least 1.5 cm in size.
- Cancer cells must have the CD20 marker.
- Must have symptoms or conditions that indicate the need for treatment.
- Must be 18 years or older.
- Must have a performance status score of 0 to 2, indicating good overall health.
- Must be able to swallow pills.
- Must be willing to follow the study requirements.
- Women must not be able to become pregnant or must have a negative pregnancy test.
- Participants of childbearing potential must agree to use effective birth control during and after treatment.
- Must have adequate organ function.
Exclusion Criteria
- Previous treatment for lymphoma, except for certain steroid use.
- Previous use of a BTK inhibitor.
- Known severe allergy to rituximab.
- History of other cancers unless disease-free for at least 2 years, with some exceptions.
- Evidence of aggressive lymphoma types.
- Lymphoma involving the central nervous system.
- Known bleeding disorders.
- Use of certain blood thinners.
- Need for certain medications that affect drug metabolism.
- Active infections or recent major infections.
- HIV infection.
- Active hepatitis B or C infections.
- Recent vaccination with a live vaccine.
- History of uncontrolled seizures.
- Significant heart disease or recent heart events.
- Uncontrolled high blood pressure.
- Recent stroke or brain bleeding.
- Recent major surgery.
- Any serious illness or condition that could affect safety or study results.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Moffitt Cancer Center | 33612 | Tampa | Florida |
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