Trial of Bendamustine And Rituximab for Patients With Previously Untreated Extranodal Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma

Inclusion criteria

• Histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any extranodal site (WHO classification)
• Any stage (Ann Arbor I-IV)
• The novo disease en any extranodal site. For primary gastric or cutaneous lymphoma, local/specific previous treatment is accepted, just following the below criteria:

• Cutaneous lymphoma: recurrent lymphoma after local therapy
• Gastric lymphoma:

b1. H. pylori-negative cases, either de novo (non pre-treated) or at relapse following local therapy (i.e., surgery, radiotherapy or antibiotics).

b2. H. pylori-positive cases at diagnosis, who failed antibiotic therapy, including patients with: clinical (endoscopic) and histological evidence of disease progression at any time post H. pylori eradication; stable disease with persistent lymphoma at 1 year post H. pylori eradication; relapse (without H. pylori re-infection), after a remission; patients who failed either first line antibiotics or further local treatment (surgery or radiotherapy)

• No evidence of histologic transformation to a high grade lymphoma
• Measurable or evaluable disease
• Age >18 and <85
• ECOG performance status 0-2
• Life expectancy of at least 1 year
• Written informed consent given according to national/local regulations

Exclusion criteria

• Prior chemotherapy or prior immunotherapy with any anti-CD20 monoclonal antibody
• Prior radiotherapy in the last 6 weeks
• Corticosteroids during the last 28 days, unless prednisone chronically administered at a dose <20 mg/day for indications other than lymphoma or lymphoma-related symptoms
• Major impairment of renal function (serum creatinine > 2,5 x upper normal) or liver function (ASAT/ALAT <2,5 x upper normal, total bilirubin <2,5x upper normal), unless due to lymphoma involvement.
• Impairment of bone marrow function (WBC <3.0x109/L, ANC <1.5x109/L, PLT <100x109/L), unless due to lymphoma involvement
• Evidence of clinically significant cardiac, neurological or metabolic disease, unless due to lymphoma involvement
• Evidence of symptomatic central nervous system (CNS) disease
• Active HBV and/or HCV infection
• Known HIV infection
• Prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer
• Any psychiatric disease potentially hampering compliance with the study protocol and follow-up schedule
• Potential to attend regular visits to the hospital, on an outpatient regimen
• Hypersensibility to any compound of the study medication.
• Non appropriate contraceptive method in women of childbearing potential or men
• Treatment with any drug under research within 30 days previous to start the study medication.