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临床试验/NCT04048395
NCT04048395Unknown不适用

Clinical Outcomes of Early-progressed Follicular Lymphoma in Korea : A Multicenter, Retrospective Analysis

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年7月8日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Overall survival

研究概览

简要总结

This retrospective study was proposed by the investigators to analyze treatment status and outcome in patients with early relapsed follicular lymphoma. In patients with follicular lymphoma who experienced disease progression within 24 months after initiation of treatment, the second-line therapy, stem cell transplantation, tumor response, progression free survival, and overall survival will be analyzed.

详细描述

Follicular lymphoma is the second most common non-Hodgkin's lymphoma in Western countries, but it is relatively less frequent in Asia. As a result, the prognosis and treatment status in Korean patients with follicular lymphoma have been rarely studied.

With the recent addition of monoclonal antibodies targeting CD20 into existing cytotoxic chemotherapy, the overall life expectancy of patients with follicular lymphoma has improved a lot. However, nearly 20% of these patients experience early worsening of disease within the first 24 months of treatment, followed by poor prognosis. Since patients with early relapse within 24 months usually experience worsening of disease during treatment with rituximab combined with chemotherapy or during rituximab maintenance therapy, optimal treatment for such patients is unknown, but remission induction therapy followed by stem cell transplantation, bendamustine combined with obinutuzumab, PI3K inhibitors, and lenalidomide are possible options. However, most of these drugs are limited for use in Korea, and there is little information with regard to treatment guidelines for patients with early relapsed follicular lymphoma or their treatment outcome in Korea.

This retrospective study was proposed by the investigators to analyze treatment status and outcome in patients with early relapsed follicular lymphoma. This study will provide basic data for follicular lymphoma study in Korea and for future clinical trial design.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients histologically diagnosed with follicular lymphoma (ICD-10 C82.0 to C82.9)
  • Radiologically confirmed disease progression within 24 months from the start date of an induction chemotherapy
  • All of the following should be available for retrospective analysis.
  • Pathologic findings report
  • Medical records containing age, sex, date of diagnosis, clinical symptoms, laboratory findings, treatment methods, progression, survival, death, etc.

排除标准

  • Known histologic transformation to aggressive lymphoma
  • Follicular lymphoma grade 3B
  • Patients whose pathologic findings report and appropriate medical records are not available

结局指标

主要结局

Overall survival

时间窗: from the date of the IRB approval until 12 month

Overall survival is defined as the time from the diagnosis to death or last follow-up.

次要结局

  • Progression free survival(from the date of the IRB approval until 12 month)

研究者

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

Won Seog Kim

Principal Investigator

Samsung Medical Center

研究点 (1)

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