Marginal Zone Lymphoma Cohort in Korea

Sponsor

Dong-A University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02732236

Collaborator

(none)

500

Enrollment

Location

107.1

Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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 :

Mar 1, 2013

Anticipated Primary Completion Date :

Feb 1, 2020

Anticipated Study Completion Date :

Feb 1, 2022

Outcome Measures

Primary Outcome Measures

Hepatitis B virus reactivation in patients with marginal zone B-cell lymphoma after rituximab containing treatment [up to 12 months]
Rate of HBV reactivation