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

• Status: Completed
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Konkuk University Medical Center
• Collaborator: Seoul St. Mary's Hospital
• Treatments: Cyclophosphamide; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Rituximab; Vincristine

Criteria

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