MALIBU Trial - Combination of Ibrutinib and Rituximab in Untreated Marginal Zone Lymphomas

Inclusion criteria

• ✓. EMZL (MALT Lymphoma) patients with MALT- IPI score 1-2 in need of systemic therapy.
• ✓.1.The following patients with gastric MALT Lymphoma can be entered:
• ✓. H. pylori-negative cases, either de novo (non pretreated) or at relapse following local therapy (i.e., surgery, radiotherapy or antibiotics).
• ✓. H. pylori-positive cases at diagnosis, who either first line antibiotics or further local treatment (surgery or radiotherapy), including patients with:
• ✓. SMZL patients in need of therapy. Either de novo or relapsed following local therapy \[including surgery and antiviral therapy for Hepatitis C virus (HCV)\]. Patient must have a symptomatic disease requiring treatment and be not eligible for splenectomy or not willing to undergo splenectomy.
• ✓.1. Patients with SMZL can be entered if any of the following criteria is present:
• ✓. bulky progressive or painful splenomegaly;
• ✓. enlarged lymph nodes or involvement of extranodal sites with or without cytopenias , i.e. involvement of ≥3 nodal sites, each with a diameter of ≥3 cm. Any nodal tumor mass with a diameter of ≥7 cm (GELG criteria, as adopted in follicular lymphoma);

Exclusion criteria