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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02732236
Other study ID # CISL-12-07
Secondary ID
Status Recruiting
Phase
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
Health authority
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

Study Design


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
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