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

Sponsor

Konkuk University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01427114

Collaborator

Seoul St. Mary's Hospital (Other)

Enrollment

Locations

Arm

114.1

Actual Duration (Months)

16.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: rituximab, cyclophosphamide, vincristine, and prednisolone	Phase 2

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

Actual Enrollment :

33 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 1, 2011

Actual Primary Completion Date :

Aug 1, 2014

Actual Study Completion Date :

Jan 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: R-CVP 6 cycles of R-CVP followed by 2 cycles of rituximab	Drug: rituximab, cyclophosphamide, vincristine, and prednisolone 6 cycles of R-CVP followed by 2 cycles of rituximab Other Names: 6 cycles of R-CVP followed by 2 cycles of rituximab

Arm

Intervention/Treatment

Experimental: R-CVP

6 cycles of R-CVP followed by 2 cycles of rituximab

Drug: rituximab, cyclophosphamide, vincristine, and prednisolone

6 cycles of R-CVP followed by 2 cycles of rituximab

Other Names:

6 cycles of R-CVP followed by 2 cycles of rituximab

Outcome Measures

Primary Outcome Measures

complete response rate [3 years]
CR rate

Secondary Outcome Measures

Progression free survival [5 years]
Progression free survival
Overall survival [5 years]
Overall survival
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [5 years]
Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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:

Transaminase (AST/ALT) ≥3 times the upper normal value or ii. Bilirubin ≥2 times the upper normal value

Inadequate renal function:

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