R-CVP for the Treatment of Non-conjunctival Ocular Adnexal MALT Lymphoma (OAML)
R-CVP for the Treatment of Non-conjunctival Ocular Adnexal MALT Lymphoma (OAML)
The purpose of this study is to determine how efficient the combination of rituximab,
 cyclophosphamide, vincristine, and prednisolone (R-CVP) is in the treatment of stage I or II
 non-conjunctival ocular adnexal MALT lymphoma (OAML).
The treatment of stage I or II OAML is mainly composed of radiotherapy because chemotherapy
 including cyclophosphamide, vincristine, and prednisolone (CVP) did not show the acceptable
 response rate compared with radiotherapy. However, radiotherapy for this disease can cause
 many complications of eyes. This clinical trial was designed to examine the efficacy of R-CVP
 combination therapy as a first-line treatment for stage I or II non-conjunctival OAML aiming
 to avoid radiation hazard and increase the efficacy of CVP chemotherapy.
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