LymphomaPhase 2NCT01427114
R-CVP for the Treatment of Non-conjunctival Ocular Adnexal MALT Lymphoma (OAML)
A Phase 2 study testing rituximab, cyclophosphamide, vincristine, and prednisolone in people with Lymphoma, run by Konkuk University Medical Center at 2 sites in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- rituximab, cyclophosphamide, vincristine, and prednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 1 Jul 2011to 1 Jan 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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:
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- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul St. Mary's Hospital
Seoul, 137-701
KonKuk University Medical Center
Seoul, 143-729
About this study
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
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).
Read the 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.
- Conditions
- Lymphoma
- Being tested
- rituximab, cyclophosphamide, vincristine, and prednisolone
- Keywords
- extranodal marginal zone lymphoma, ocular adnexal lymphoma, mucosa associated lymphoid tissue, cyclophosphamide, vincristine, prednisolone
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximab, cyclophosphamide, vincristine, and prednisoloneDrug
Also called 6 cycles of R-CVP followed by 2 cycles of rituximab
6 cycles of R-CVP followed by 2 cycles of rituximab
| Study group | Role | What they receive |
|---|---|---|
| R-CVP | Experimental | 6 cycles of R-CVP followed by 2 cycles of rituximab Receives: Drug: rituximab, cyclophosphamide, vincristine, and prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete response rate
CR rate
Measured: 3 years
Secondary outcomes (3)
Progression free survival
Progression free survival
Measured: 5 years
Overall survival
Overall survival
Measured: 5 years
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study start1 Jul 2011
- Primary completion1 Aug 2014
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul St. Mary's Hospital
- Responsible party
- Principal investigator, Sung-Yong Kim, Konkuk University Medical Center
- Investigators
- Seok-Goo Cho, Ph.D., Principal investigator, Seoul St. Mary's HospitalSung-Yong Kim, Ph.D., Principal investigator, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427114
- Sponsor's protocol ID
- KUH1010258
- Status last verified
- May 2021
- First submitted
- 30 Aug 2011
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28978139
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01427114
- Acronym / sponsor ID
- KUH1010258
- Conditions
- Lymphoma
- Keywords
- extranodal marginal zone lymphoma, ocular adnexal lymphoma, mucosa associated lymphoid tissue, cyclophosphamide, vincristine, prednisolone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Collaborators
- Seoul St. Mary's Hospital
- Study start
- 1 Jul 2011 (actual)
- Primary completion
- 1 Aug 2014 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 1 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| R-CVP | Experimental | Drug: rituximab, cyclophosphamide, vincristine, and prednisolone6 cycles of R-CVP followed by 2 cycles of rituximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rituximab, cyclophosphamide, vincristine, and prednisoloneAlso: 6 cycles of R-CVP followed by 2 cycles of rituximab6 cycles of R-CVP followed by 2 cycles of rituximab | Drug | R-CVP |
Primary outcome
complete response rate
Time frame: 3 years
CR rate
3 secondary outcomes
Progression free survival
Time frame: 5 years
Overall survival
Time frame: 5 years
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Derived from this study: PubMed 28978139Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seok-Goo Cho, Ph.D. principal investigator
Seoul St. Mary's Hospital
Sung-Yong Kim, Ph.D. principal investigator
Konkuk University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rituximab, cyclophosphamide, vincristine, and prednisolone in people with Lymphoma, run by Konkuk University Medical Center at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete response rate (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01427114, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.