LymphomaPhase 2NCT01213095
Rituximab Maintenance Therapy for Marginal Zone B-cell Lymphoma (MZL)
A Phase 2 study testing rituximab in people with Lymphoma, run by Dong-A University Hospital at 1 site in South Korea.
Trial summary
The clinical efficacy of rituximab, a chimeric monoclonal antibody targeted toward the B-cell specific antigen CD20, was initially demonstrated in cases of follicular lymphoma (FL), but the use of this antibody has been extended over the last few years to the majority of subtypes of B-cell CD20 positive non-Hodgkin's… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2010to Sep 2015
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed CD20 positive marginal zone B-cell lymphomas
- Ann Arbor stage III or IV
- No prior chemotherapy or radiotherapy for advanced stage MZL
- Tumor response after 8th cycles of R-CVP CTx ≥ SD (Stable disease)
- Performance status (ECOG) ≤ 2
- age ≥ 20
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- At least one or more bidimensionally measurable lesion(s): ≥ 2 cm by conventional CT/ ≥ 1 cm by spiral CT/ skin lesion (photographs should be taken) ≥ 2 cm/ measurable lesion by physical examination ≥ 2 cm
- Adequate renal function: serum creatinine level < 2 mg/dL (177 μmol/L)
- Adequate liver functions: Transaminase (AST/ALT) < 3 X upper normal value / Bilirubin < 1.5 X upper normal value /Alkaline phosphatase < 5 X upper normal value
- Adequate BM functions:ANC > 1500/uL and platelet > 75,000/uL and Hemoglobin > 9.0 g/dL unless abnormalities are due to bone marrow involvement by lymphoma
- Informed consent
Who cannot join
- Other subtypes NHL than MZL
- Large cell component >10%
- Tumor response after 8th cycles CTx = PD (Progression disease)
- Central nervous system (CNS) metastasis
- Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
- Pregnant or lactating women, women of childbearing potential not employing adequate contraception
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- 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 neurologic or psychiatric disorders including dementia or seizures iii. Active uncontrolled infection (viral, bacterial or fungal infection) iv. Other serious medical illnesses
- 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
1 site in 1 country.
About this study
Official title: R-CVP Followed by Rituximab Maintenance Therapy for Patients With Advanced Marginal Zone B-cell Lymphoma
The clinical efficacy of rituximab, a chimeric monoclonal antibody targeted toward the B-cell specific antigen CD20, was initially demonstrated in cases of follicular lymphoma (FL), but the use of this antibody has been extended over the last few years to the majority of subtypes of B-cell CD20 positive non-Hodgkin's lymphomas, with promising results thus far. In MZL, small numbers of case reports have chronicled the use of rituximab as a single agent or phase II trial combination with chemotherapeutic regimens.
The results of the rituximab maintenance phase III trial demonstrated that patients with FL who continued to take rituximab monotherapy as a maintenance therapy after responding to an initial course of chemotherapy combined with or without rituximab experienced longer progression-free survival durations than did those who received no rituximab maintenance therapy. The efficacy of maintenance treatment after first-line induction treatment with R-chemotherapy was addressed in the international PRIMA (Primary Rituximab and Maintenance) study, which has enrolled 1,217 patients. The first results are eagerly awaited. Although MZL has better prognosis in TTP and OS than FL, both of them are classified as the same category of indolent lymphoma -characterized by frequent relapse and prolonged survival.
According to the results of our survey, advanced stage MZL tends to be an indolent disease - characterized by prolonged survival with frequent relapses. Rituximab appears to contribute to better responses, but not in TTP. Thus, we should consider maintenance treatments for MZL patients, to extend their response duration.
Read the detailed description
no desire description
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabDrug
rituximab 375mg/m2, every 8 weeks, 12 times
| Study group | Role | What they receive |
|---|---|---|
| Rituximab | Experimental | rituximab 375mg/m2, every 8 weeks, 12 times Receives: Drug: rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 year progression free survival
Historic 3 year progression free survival rate was 60 %, expected difference 20%, power 0.80, significance 0.05 and drop rate=0.1.
Measured: 3 years after last patient enrollment
Secondary outcomes (2)
Overall survival
Measured: 5 years after last patients enrollment
toxicity
Measured: during the Rituximab maintenance treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2013
- Study completionSep 2015
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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung Yong Oh, Dong-A University Hospital
- Investigators
- Sung Yong Oh, M.D., Study director, Dong-A University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213095
- Sponsor's protocol ID
- CISL-MZL-10-4(ML25403)
- Status last verified
- Nov 2014
- First submitted
- 30 Sep 2010
- Last updated
- 11 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Oh SY, Kim WS, Kim JS, Kim SJ, Yoon DH, Yang DH, Lee WS, Kim HJ, Yhim HY, Jeong SH, Won JH, Lee S, Kong JH, Lim SN, Ji JH, Kwon KA, Lee GW, Lee JH, Lee HS, Shin HJ, Suh C. Phase II study of R-CVP followed by rituximab maintenance therapy for patients with advanced marginal zone lymphoma: consortium for improving survival of lymphoma (CISL) study. Cancer Commun (Lond). 2019 Oct 16;39(1):58. doi: 10.1186/s40880-019-0403-7.
PubMed 31619290
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- R-CVP Followed by Rituximab Maintenance Therapy for Patients With Advanced Marginal Zone B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT01213095
- Acronym / sponsor ID
- CISL-MZL-10-4(ML25403)
- Conditions
- Lymphoma
- Keywords
- Lymphoma, B-Cell, Marginal Zone, Rituximab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Dong-A University HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 1 Oct 2010 (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 clinical efficacy of rituximab, a chimeric monoclonal antibody targeted toward the B-cell specific antigen CD20, was initially demonstrated in cases of follicular lymphoma (FL), but the use of this antibody has been extended over the last few years to the majority of subtypes of B-cell CD20 positive non-Hodgkin's lymphomas, with promising results thus far. In MZL, small numbers of case reports have chronicled the use of rituximab as a single agent or phase II trial combination with chemotherapeutic regimens.
The results of the rituximab maintenance phase III trial demonstrated that patients with FL who continued to take rituximab monotherapy as a maintenance therapy after responding to an initial course of chemotherapy combined with or without rituximab experienced longer progression-free survival durations than did those who received no rituximab maintenance therapy. The efficacy of maintenance treatment after first-line induction treatment with R-chemotherapy was addressed in the international PRIMA (Primary Rituximab and Maintenance) study, which has enrolled 1,217 patients. The first results are eagerly awaited. Although MZL has better prognosis in TTP and OS than FL, both of them are classified as the same category of indolent lymphoma -characterized by frequent relapse and prolonged survival.
According to the results of our survey, advanced stage MZL tends to be an indolent disease - characterized by prolonged survival with frequent relapses. Rituximab appears to contribute to better responses, but not in TTP. Thus, we should consider maintenance treatments for MZL patients, to extend their response duration.
Detailed description
no desire description
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rituximab | Experimental | Drug: rituximabrituximab 375mg/m2, every 8 weeks, 12 times |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed CD20 positive marginal zone B-cell lymphomas
- Ann Arbor stage III or IV
- No prior chemotherapy or radiotherapy for advanced stage MZL
- Tumor response after 8th cycles of R-CVP CTx ≥ SD (Stable disease)
- Performance status (ECOG) ≤ 2
Key exclusion criteria (9 listed)
- Other subtypes NHL than MZL
- Large cell component >10%
- Tumor response after 8th cycles CTx = PD (Progression disease)
- Central nervous system (CNS) metastasis
- Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
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 |
|---|---|---|
| rituximabrituximab 375mg/m2, every 8 weeks, 12 times | Drug | Rituximab |
Primary outcome
3 year progression free survival
Time frame: 3 years after last patient enrollment
Historic 3 year progression free survival rate was 60 %, expected difference 20%, power 0.80, significance 0.05 and drop rate=0.1.
2 secondary outcomes
Overall survival
Time frame: 5 years after last patients enrollment
toxicity
Time frame: during the Rituximab maintenance treatment
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 11 Apr 2016.
- Derived from this study: PubMed 31619290Oh SY, Kim WS, Kim JS, Kim SJ, Yoon DH, Yang DH, Lee WS, Kim HJ, Yhim HY, Jeong SH, Won JH, Lee S, Kong JH, Lim SN, Ji JH, Kwon KA, Lee GW, Lee JH, Lee HS, Shin HJ, Suh C. Phase II study of R-CVP followed by rituximab maintenance therapy for patients with advanced marginal zone lymphoma: consortium for improving survival of lymphoma (CISL) study. Cancer Commun (Lond). 2019 Oct 16;39(1):58. doi: 10.1186/s40880-019-0403-7.
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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.
Sung Yong Oh, M.D. study director
Dong-A University Hospital
1 site 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 in people with Lymphoma, run by Dong-A University Hospital at 1 site 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 11 inclusion and 9 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 11 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
3 year progression free survival (time frame: 3 years after last patient enrollment). 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 NCT01213095, 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 11 Apr 2016.