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