Phase II Study of Rituximab and Venetoclax for Initial Treatment of Marginal Zone Lymphoma

Inclusion Criteria

• Must be 18 years or older.
• Have a confirmed diagnosis of Marginal Zone Lymphoma.
• Have measurable disease, such as a lymph node 1.5 cm or larger or an enlarged spleen.
  • For intestinal MALT lymphoma, the disease must be detectable by specific medical procedures.
• For gastric MALT lymphoma, must be negative for H. pylori bacteria, or if positive, must have failed H. pylori eradication treatment.
• Must be ineligible for, have refused, or failed gastric radiation therapy if they have gastric MALT lymphoma that is H. pylori negative or has relapsed.
• Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Have a life expectancy of more than 2 years.
• Have normal organ function, including:
  • Platelet count of at least 50,000 cells/mm³.
  • Hemoglobin level of at least 8.0 g/dL.
  • Neutrophil count of at least 1000 cells/mcL, or 500 cells/mcL if bone marrow is involved.
  • Total bilirubin less than 1.5 times the normal limit, or up to 3 times if liver is involved.
  • Liver enzymes within specified limits unless affected by MZL.
  • Creatinine clearance above 60 mL/min if creatinine levels are high.
• Must be able to understand and sign a consent form.
• Must be able to swallow pills.
• HIV-positive patients can participate if their condition is well-controlled and CD4 count is above 300.
• Patients with certain Hepatitis B conditions are eligible if under control.

Exclusion Criteria

• Have had previous systemic therapy, including rituximab.
• Have had previous radiation therapy, except for palliative care completed at least one week before the study.
• Have been treated with ibrutinib or other BTK inhibitors.
• Have H. pylori-associated gastric MALT or early-stage MZL unless unfit for radiation therapy.
• Have uncontrolled illnesses, such as active infections, heart failure, unstable chest pain, or psychiatric conditions affecting study participation.
• Pregnant or breastfeeding women.
• Unwilling to use effective contraception for 12 months after the last dose of rituximab.
• Have taken certain medications that affect venetoclax within 7 days before starting the study.