Study of Ibrutinib and Rituximab for Untreated Marginal Zone Lymphoma

Inclusion Criteria

• Diagnosed with marginal zone lymphoma, including types that affect the spleen, lymph nodes, or other areas.
• No previous systemic treatment for MZL, except for certain antibiotics or antiviral treatments.
• Must be 18 years or older.
• For those with gastric MALT lymphoma, must be negative for H. pylori or have tried and not succeeded with H. pylori treatment.
• Must not be eligible for or have refused gastric radiation therapy if needed.
• Must be in good general health with an ECOG performance status of 0 to 2.
• Must have at least one measurable tumor on a CT scan or MRI.
• Must have a life expectancy of more than 3 months.
• Women must not be able to become pregnant or must have a negative pregnancy test.
• Must agree to use effective birth control during and after the study.
• Must have a documented need for treatment, such as large tumors or symptoms requiring medical intervention.
• Must have tumor and bone marrow biopsies if there is a suspicion of disease transformation.

Exclusion Criteria

• Have lymphoma affecting the brain or spinal fluid.
• Have another cancer that could interfere with the study.
• Have had another cancer, except for certain skin cancers or other cancers treated successfully over 2 years ago.
• Have taken certain medications that affect the liver within 7 days before starting the study.
• Are on medications that suppress the immune system within 28 days before starting the study.
• Have significant heart disease or recent heart problems.
• Have had a recent infection requiring treatment within 14 days before starting the study.
• Have an active infection that is not controlled.
• Have a bleeding disorder or hemophilia.
• Have hepatitis B or C, or HIV with certain conditions.
• Have low blood cell counts or abnormal liver or kidney function tests.
• Cannot swallow capsules or have digestive issues affecting medication absorption.
• Have had major surgery within 4 weeks before starting the study.
• Have a serious illness or condition that could affect safety or study results.
• Are pregnant or breastfeeding.
• Are unable or unwilling to participate in study procedures.
• Have chronic liver disease with significant impairment.