NCT01427114CompletedPhase 2
Open-labeled, Multicenter Phase II Study of Rituximab, Cyclophosphamide, Vincristine, and Prednisolone (R-CVP) Chemotherapy in Patients With Non-conjunctival Ocular Adnexal MALT Lymphoma
Konkuk University Medical Center2 sites in 1 country33 target enrollmentStarted: July 1, 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 33
- Locations
- 2
- Primary Endpoint
- complete response rate
Study Overview
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 ocular adnexal MALT lymphoma (OAML).
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
R-CVP
Experimental
6 cycles of R-CVP followed by 2 cycles of rituximab
Intervention: rituximab, cyclophosphamide, vincristine, and prednisolone (Drug)
Outcomes
Primary Outcomes
complete response rate
Time Frame: 3 years
CR rate
Secondary Outcomes
- Overall survival(5 years)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(5 years)
- Progression free survival(5 years)
Investigators
Sung-Yong Kim
Assistant Professor
Konkuk University Medical Center
Study Sites (2)
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