Status:
COMPLETED
R-CVP for the Treatment of Non-conjunctival Ocular Adnexal MALT Lymphoma (OAML)
Lead Sponsor:
Konkuk University Medical Center
Collaborating Sponsors:
Seoul St. Mary's Hospital
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ocul...
Detailed Description
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 co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2021
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01427114
Start Date
July 1 2011
End Date
January 1 2021
Last Update
May 6 2021
Active Locations (2)
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1
Seoul St. Mary's Hospital
Seoul, South Korea, 137-701
2
KonKuk University Medical Center
Seoul, South Korea, 143-729