Rituximab Maintenance Versus Observation After R2 Induction in Previously Untreated Marginal Zone Lymphoma

Rituximab Maintenance Versus Observation After Rituximab and Lenalidomide (R2) Induction in Previously Untreated Marginal Zone Lymphoma: A Multicenter, Phase 2, Randomized Trial

This is a multicenter, phase 2, randomized trial to compare rituximab maintenance with observation after rituximab and lenalidomide (R2) induction therapy in patients with previously untreated marginal zone lymphoma. Patients who achieve complete response or partial response after R2 induction will be randomized to receive rituximab maintenance or observation.

Inclusion Criteria:

• Able to understand and voluntarily sign the informed consent form.
• Age ≥18 years.
• Histologically confirmed CD20-positive marginal zone lymphoma, including extranodal, splenic, or nodal subtypes.
• Considered unsuitable for or unable to tolerate standard chemotherapy.
• Previously untreated with systemic anti-lymphoma therapy.
• Measurable or evaluable disease according to Lugano 2014 criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Adequate organ function.

Exclusion Criteria:

• History of other malignancies that may interfere with study assessment.
• Central nervous system involvement by lymphoma.
• Known HIV infection or active hepatitis B/C infection.
• Active or uncontrolled infection.
• Gastrointestinal condition that may interfere with oral administration or absorption of study treatment.
• Pregnancy or breastfeeding.