Clinical trial NCT01427114: R-CVP for the Treatment of Non-conjunctival Ocular Adnexal MALT Lymphoma (OAML)
Official title: Open-labeled, Multicenter Phase II Study of Rituximab, Cyclophosphamide, Vincristine, and Prednisolone (R-CVP) Chemotherapy in Patients With Non-conjunctival Ocular Adnexal MALT Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Keywords: extranodal marginal zone lymphoma
ocular adnexal lymphoma
mucosa associated lymphoid tissue
cyclophosphamide
vincristine
prednisolone
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
Collaborators: name: Seoul St. Mary's Hospital
First posted: 2011-09-01
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: complete response rate
timeFrame: 3 years
Secondary outcomes:
measure: Progression free survival
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: KonKuk University Medical Center
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Seok-Goo Cho, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Konkuk University Medical Center
name: Sung-Yong Kim, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim SY, Yang SW, Lee WS, Yang JW, Oh SY, Ahn HB, Yang DH, Park SK, Chang JH, Kim HJ, Lee MJ, Cho SG. Frontline treatment with chemoimmunotherapy for limited-stage ocular adnexal MALT lymphoma with adverse factors: a phase II study. Oncotarget. 2017 Aug 2;8(40):68583-68590. doi: 10.18632/oncotarget.19788. eCollection 2017 Sep 15.