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
Inactive

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

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.

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