- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02732236
Marginal Zone Lymphoma Cohort in Korea
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)
Study Overview
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Sung Yong Oh, MD, PhD
- Phone Number: +82-51-240-2808
- Email: drosy@dau.ac.kr
Study Locations
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Busan, Korea, Republic of, 602-715
- Recruiting
- Sung Yong Oh
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- pathological confirmed marginal zone lymphoma
- No history of chemotherapy
- enable to routine staging w/u and sampling including HBV serology
- informed consent
Exclusion Criteria:
- mixed with other type lymphoma
- refuse informed consent
- co-existing cancer needed treatment
- prior organ transplantation
- accompany with immunodeficiency
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
up to 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sung Yong Oh, Consortium for improving survival of lymphoma office
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, B-Cell, Marginal Zone
- Physiological Effects of Drugs
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Rituximab
Other Study ID Numbers
- CISL-12-07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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