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临床试验/NCT02732236
NCT02732236Unknown不适用

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)

Dong-A University Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
试验地点
1
主要终点
Hepatitis B virus reactivation in patients with marginal zone B-cell lymphoma after rituximab containing treatment

研究概览

简要总结

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

详细描述

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)

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • pathological confirmed marginal zone lymphoma
  • No history of chemotherapy
  • enable to routine staging w/u and sampling including HBV serology
  • informed consent

排除标准

  • mixed with other type lymphoma
  • refuse informed consent
  • co-existing cancer needed treatment
  • prior organ transplantation
  • accompany with immunodeficiency

结局指标

主要结局

Hepatitis B virus reactivation in patients with marginal zone B-cell lymphoma after rituximab containing treatment

时间窗: up to 12 months

Rate of HBV reactivation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sung Yong Oh

Associate professor

Dong-A University Hospital

研究点 (1)

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