Back to resultsR-CVP for the Treatment of Non-conjunctival Ocular Adnexal MALT Lymphoma (OAML)
Primary Purpose
Lymphoma
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
rituximab, cyclophosphamide, vincristine, and prednisolone
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring extranodal marginal zone lymphoma, ocular adnexal lymphoma, mucosa associated lymphoid tissue, cyclophosphamide, vincristine, prednisolone
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
Sites / Locations
- Seoul St. Mary's Hospital
- KonKuk University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
R-CVP
Arm Description
6 cycles of R-CVP followed by 2 cycles of rituximab
Outcomes
Primary Outcome Measures
complete response rate
CR rate
Secondary Outcome Measures
Progression free survival
Progression free survival
Overall survival
Overall survival
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Full Information
NCT ID
NCT01427114
First Posted
August 30, 2011
Last Updated
May 3, 2021
Sponsor
Konkuk University Medical Center
Collaborators
Seoul St. Mary's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01427114
Brief Title
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
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2011 (Actual)
Primary Completion Date
August 1, 2014 (Actual)
Study Completion Date
January 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konkuk University Medical Center
Collaborators
Seoul St. Mary's Hospital
4. Oversight
Data Monitoring Committee
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
extranodal marginal zone lymphoma, ocular adnexal lymphoma, mucosa associated lymphoid tissue, cyclophosphamide, vincristine, prednisolone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
R-CVP
Arm Type
Experimental
Arm Description
6 cycles of R-CVP followed by 2 cycles of rituximab
Intervention Type
Drug
Intervention Name(s)
rituximab, cyclophosphamide, vincristine, and prednisolone
Other Intervention Name(s)
6 cycles of R-CVP followed by 2 cycles of rituximab
Intervention Description
6 cycles of R-CVP followed by 2 cycles of rituximab
Primary Outcome Measure Information:
Title
complete response rate
Description
CR rate
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Progression free survival
Description
Progression free survival
Time Frame
5 years
Title
Overall survival
Description
Overall survival
Time Frame
5 years
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seok-Goo Cho, Ph.D.
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sung-Yong Kim, Ph.D.
Organizational Affiliation
Konkuk University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
KonKuk University Medical Center
City
Seoul
ZIP/Postal Code
143-729
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
28978139
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.
Results Reference
derived
Learn more about this trial
R-CVP for the Treatment of Non-conjunctival Ocular Adnexal MALT Lymphoma (OAML)
We'll reach out to this number within 24 hrs