ClinicalTrials.gov
ClinicalTrials.gov Menu

Marginal Zone Lymphoma Cohort in Korea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02732236
Recruitment Status : Recruiting
First Posted : April 8, 2016
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Sung Yong Oh, Dong-A University Hospital

Brief 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

Condition or disease Intervention/treatment
Lymphoma, B-Cell, Marginal Zone Other: Rituximab

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 [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
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)
Study Start Date : March 2013
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab


Intervention Details:
  • Other: Rituximab
    Cohort observation study


Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02732236


Contacts
Contact: Sung Yong Oh, MD, PhD +82-51-240-2808 drosy@dau.ac.kr

Locations
Korea, Republic of
Sung Yong Oh Recruiting
Busan, Korea, Republic of, 602-715
Contact: SUNG YONG OH, Professor       drosy@dau.ac.kr   
Sponsors and Collaborators
Dong-A University Hospital
Investigators
Principal Investigator: Sung Yong Oh Consortium for improving survival of lymphoma office

Responsible Party: Sung Yong Oh, Associate professor, Dong-A University Hospital
ClinicalTrials.gov Identifier: NCT02732236     History of Changes
Other Study ID Numbers: CISL-12-07
First Posted: April 8, 2016    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will share collected data with participated investigators in Korea

Keywords provided by Sung Yong Oh, Dong-A University Hospital:
marginal zone lymphoma
Cohort
Rituximab
HBV

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell, Marginal Zone
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents