Marginal Zone Lymphoma Cohort in Korea

Lymphoma, B-Cell, Marginal Zone Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02732236
• Other study ID #: CISL-12-07
• Status: Recruiting
• First received: April 4, 2016
• Last updated: April 17, 2018
• Start date: March 2013
• Est. completion date: February 2022

Study information

• Verified date: April 2018
• Source: Dong-A University Hospital
• Contact: Sung Yong Oh, MD, PhD
• Phone: +82-51-240-2808
• Email: drosy[@]dau.ac.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 2022
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, B-Cell, Marginal Zone

Intervention

Other:
• Rituximab
Cohort observation study

Locations

Country	Name	City	State
Korea, Republic of	Sung Yong Oh	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatitis B virus reactivation in patients with marginal zone B-cell lymphoma after rituximab containing treatment	Rate of HBV reactivation	up to 12 months