Randomized Trial of Chlorambucil Versus Chlorambucil Plus Rituximab Versus Rituximab in MALT Lymphoma

Inclusion Criteria

• •1. histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any extranodal site
• •2. any stage (Ann Arbor I-IV)
• •3. either de novo, or relapsed disease following local therapy (including surgery, radiotherapy and antibiotics for H. pylori-positive gastric lymphoma)
• •4. no evidence of histologic transformation to a high grade lymphoma
• •5. measurable or evaluable disease
• •6. age \> 18
• •7. life expectancy of at least 1 year
• •8. ECOG performance status 0-2
• •9. no prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer
• •10. no prior chemotherapy
• •11. no prior immunotherapy with any anti-CD20 monoclonal antibody
• •12. no prior radiotherapy in the last 6 weeks
• •13. no 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
• •14. no evidence of clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months before study entry
• •15. no evidence of symptomatic central nervous system (CNS) disease
• •16. no impairment of bone marrow function (WBC \>3.0x109/L, ANC \>1.5x109/L, PLT \>100x109/L), unless due to lymphoma involvement
• •17. no major impairment of renal function (serum creatinine \<1,5x upper normal) or liver function (ASAT/ALAT \<2,5 upper normal, total bilirubin \<2,5x upper normal), unless due to lymphoma involvement
• •18. no evidence of active opportunistic infections
• •19. no known HIV infection
• •20. no active HBV and/or HCV infection
• •21. no pregnant or lactating status
• •22. appropriate contraceptive method in women of childbearing potential or men
• •23. absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
• •24. informed consent must be given according to national/local regulations before randomization