R-CVP for the Treatment of Non-conjunctival Ocular Adnexal MALT Lymphoma (OAML)

Inclusion Criteria:

• Histologically confirmed OAML
• Non-conjunctival or bilateral conjunctival (TNM-based, above T1N0M0 or bT1N0M0), Ann Arbor stage I and II OAML
• Previously untreated
• Age ≥18 years
• Performance status: ECOG 0-2
• Adequate hematological function: hemoglobin ≥9 g/dL,, absolute neutrophil count (ANC) ≥1,500/μL, and platelet count ≥100,000/μL, unless abnormalities are due to bone marrow involvement by the lymphoma

• Adequate liver function tests:

  i. Transaminase (AST/ALT) <3 times the upper normal value ii. Bilirubin <2 times the upper normal value

• Adequate renal function:serum creatinine level <2 mg/dL (177 μmol/L)
• Life expectancy ≥ 6 months
• A negative serum or urine pregnancy test before treatment must be available for both premenopausal women and for women who have <2 years after the onset of menopause.
• Informed consent

Exclusion Criteria:

• NHL subtypes other than OAML
• Primary conjunctival OAML, unilateral involved (T1N0M0)
• Ann Arbor stage III or IV
• CNS involvement by the lymphoma or any evidence of spinal cord compression. Brain CT/MRI is only mandatory (within 4 weeks) with clinical suspicion of CNS involvement by the lymphoma
• Pregnant or lactating women, women of child-bearing potential not using adequate contraception

• Inadequate liver function tests:

  i. Transaminase (AST/ALT) ≥3 times the upper normal value or ii. Bilirubin ≥2 times the upper normal value

• Inadequate renal function:

  i. serum creatinine level <2 mg/dL (177 μmol/L)

• Other serious illness or medical conditions i. Unstable cardiac disease despite treatment; myocardial infarction within 6 months prior to study entry ii. History of significant neurological or psychiatric disorders including dementia or seizures
• Active uncontrolled infection (HIV, hepatitis B, Hepatitis C, active Tuberculosis, active bacterial, or active fungal infection)
• Any other malignancies within the past 5 years except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
• Known hypersensitivity to any of the study drugs or its ingredients (i.e., hypersensitivity to Polysorbate 20, CHO cell products, or recombinant human antibodies)
• Concomitant administration of any other experimental drug under investigation or concomitant chemotherapy, hormonal therapy, or immunotherapy