Marginal Zone Lymphoma Cohort in Korea

April 17, 2018 updated by: Sung Yong Oh, Dong-A University Hospital

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patients who is diagnosed as a marginal zone lymphoma- nodal MZL, marginal zone lymphoma of MALT type, splenic MZL

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A University Hospital

Investigators

  • Principal Investigator: Sung Yong Oh, Consortium for improving survival of lymphoma office

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ANTICIPATED)

February 1, 2020

Study Completion (ANTICIPATED)

February 1, 2022

Study Registration Dates

First Submitted

April 4, 2016

First Submitted That Met QC Criteria

April 4, 2016

First Posted (ESTIMATE)

April 8, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 18, 2018

Last Update Submitted That Met QC Criteria

April 17, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CISL-12-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will share collected data with participated investigators in Korea

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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