R-CVP for the Treatment of Non-conjunctival Ocular Adnexal MALT Lymphoma (OAML) (NCT01427114) | Clinical Trial Compass
CompletedPhase 2
R-CVP for the Treatment of Non-conjunctival Ocular Adnexal MALT Lymphoma (OAML)
South Korea33 participantsStarted 2011-07-01
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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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 m…