Lymphoma, B-Cell, Marginal ZoneNCT02732236
Marginal Zone Lymphoma Cohort in Korea
An observational study of Lymphoma, B-Cell, Marginal Zone, run by Dong-A University Hospital at 1 site in South Korea.
Trial summary
Marginal zone lymphoma is a rare of subtype of Non-Hodgkin Lymphoma. Because of its rarity, prospective clinical trial is difficult to conduct. Therefore we want to make prospective MZL patients' cohort for several observation study Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lymphoma, B-Cell, Marginal Zone
- What is being tested?
- Rituximab
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2013to Feb 2022
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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
Study population: The patients who is diagnosed as a marginal zone lymphoma- nodal MZL, marginal zone lymphoma of MALT type, splenic MZL
Who may be able to join
- pathological confirmed marginal zone lymphoma
- No history of chemotherapy
- enable to routine staging w/u and sampling including HBV serology
- informed consent
Who cannot join
- mixed with other type lymphoma
- refuse informed consent
- co-existing cancer needed treatment
- prior organ transplantation
- accompany with immunodeficiency
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Sung Yong Oh
Busan, 602-715
SUNG YONG OH, Professor, drosy@dau.ac.kr
About this study
Official title: Hepatitis B Virus Reactivation in Patients With Marginal Zone B-cell Lymphoma After Rituximab Containing Treatment: Consortium for Improving Survival of Lymphoma (CISL) Marginal Zone Lymphoma Cohort Study (MARCO)
Marginal zone lymphoma is a rare of subtype of Non-Hodgkin Lymphoma. Because of its rarity, prospective clinical trial is difficult to conduct. Therefore we want to make prospective MZL patients' cohort for several observation study
Read the detailed description
Marginal zone lymphoma (MZL) is a distinct subgroup of non-Hodgkin's lymphoma (NHL), which is typically characterized by an indolent clinical course and long survival duration. MZL is responsible for approximately 7~8% of all NHL. In Korea, MZL accounts for 21% of all B-cell lymphoma and is the second most frequent histologic subtype following diffuse large B-cell lymphoma. Annually, an estimated 500 patients are newly diagnosed with MZL. According to the previous large-scale analyses, MZL is usually a quiet indolent malignancy, which generally presents with limited stage of disease. Localized disease may be controlled with local treatment, and a high response rate can be achieved. Advanced MZL is associated with less favorable survival, and appears to be incurable with the currently available therapy. Transformation to large cell aggressive lymphoma may occur in the first recurrence or in subsequent relapses.
Because of its rarity, prospective clinical trial is difficult to conduct. Therefore we want to make prospective MZL patients' cohort for several observation study especially related with Rituximab use (ex, Hepatitis B virus (HBV) reactivation)
- Conditions
- Lymphoma, B-Cell, Marginal Zone
- Being tested
- Rituximab
- Keywords
- marginal zone lymphoma, Cohort, Rituximab, HBV
- Medical subject headings
- Lymphoma, B-Cell, Marginal Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabOther
Cohort observation study
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatitis B virus reactivation in patients with marginal zone B-cell lymphoma after rituximab containing treatment
Rate of HBV reactivation
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study startMar 2013
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, B-Cell, Marginal ZoneStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
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, Principal investigator, Consortium for improving survival of lymphoma office
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732236
- Sponsor's protocol ID
- CISL-12-07
- Status last verified
- Apr 2018
- First submitted
- 4 Apr 2016
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: We will share collected data with participated investigators in Korea
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis B Virus Reactivation in Patients With Marginal Zone B-cell Lymphoma After Rituximab Containing Treatment: Consortium for Improving Survival of Lymphoma (CISL) Marginal Zone Lymphoma Cohort Study (MARCO)
- ClinicalTrials.gov ID
- NCT02732236
- Acronym / sponsor ID
- CISL-12-07
- Conditions
- Lymphoma, B-Cell, Marginal Zone
- Keywords
- marginal zone lymphoma, Cohort, Rituximab, HBV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Dong-A University HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 8 Apr 2016 (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.
Marginal zone lymphoma is a rare of subtype of Non-Hodgkin Lymphoma. Because of its rarity, prospective clinical trial is difficult to conduct. Therefore we want to make prospective MZL patients' cohort for several observation study
Detailed description
Marginal zone lymphoma (MZL) is a distinct subgroup of non-Hodgkin's lymphoma (NHL), which is typically characterized by an indolent clinical course and long survival duration. MZL is responsible for approximately 7~8% of all NHL. In Korea, MZL accounts for 21% of all B-cell lymphoma and is the second most frequent histologic subtype following diffuse large B-cell lymphoma. Annually, an estimated 500 patients are newly diagnosed with MZL. According to the previous large-scale analyses, MZL is usually a quiet indolent malignancy, which generally presents with limited stage of disease. Localized disease may be controlled with local treatment, and a high response rate can be achieved. Advanced MZL is associated with less favorable survival, and appears to be incurable with the currently available therapy. Transformation to large cell aggressive lymphoma may occur in the first recurrence or in subsequent relapses.
Because of its rarity, prospective clinical trial is difficult to conduct. Therefore we want to make prospective MZL patients' cohort for several observation study especially related with Rituximab use (ex, Hepatitis B virus (HBV) reactivation)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who is diagnosed as a marginal zone lymphoma- nodal MZL, marginal zone lymphoma of MALT type, splenic MZL
Key inclusion criteria (4 listed)
- pathological confirmed marginal zone lymphoma
- No history of chemotherapy
- enable to routine staging w/u and sampling including HBV serology
- informed consent
Key exclusion criteria (5 listed)
- mixed with other type lymphoma
- refuse informed consent
- co-existing cancer needed treatment
- prior organ transplantation
- accompany with immunodeficiency
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 |
|---|---|---|
| RituximabCohort observation study | Other | – |
Primary outcome
Hepatitis B virus reactivation in patients with marginal zone B-cell lymphoma after rituximab containing treatment
Time frame: up to 12 months
Rate of HBV reactivation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Individual participant dataSharing planned: Yes. We will share collected data with participated investigators in Korea
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Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
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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 principal investigator
Consortium for improving survival of lymphoma office
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, B-Cell, Marginal Zone, 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 Apr 2018. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sung Yong Oh, MD, PhD (+82-51-240-2808, drosy@dau.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatitis B virus reactivation in patients with marginal zone B-cell lymphoma after rituximab containing treatment (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2018.