Open-labeled, multicenter phase II study of rituximab, cyclophosphamide, vincristine, and prednisolone (R-CVP) chemotherapy in patients with non-conjunctival ocular adnexal MALT lymphoma.

The Catholic University of Korea, Seoul St. Mary's Hospital0 个研究点目标入组 33 人开始时间: 待定最近更新: 2019年3月11日

研究概览

暂无简介。

•<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

发起方

The Catholic University of Korea, Seoul St. Mary's Hospital