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临床试验/NCT04061850
NCT04061850已完成不适用

Ibrutinib for Relapsed or Refractory Mantle Cell Lymphoma: Multicenter Retrospective Analysis

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
88
试验地点
1
主要终点
Progression free survival period

研究概览

简要总结

To review the efficacy and the safety of ibrutinib in patients with relapsed or refractory mantle cell lymphoma (MCL).

详细描述

Background and Rationale Mantle cell lymphoma (MCL) is a rare subtype of lymphoma, accounting for about 3-6% of all non-Hodgkin's lymphoma. It is clinically prevalent in the elderly and men, commonly with gastrointestinal tract involvement. Since about 80% of patients present with advanced stage disease at diagnosis, the prognosis is very poor. Mantle cell lymphoma is less frequent in Korean than in Western countries, accounting for about 2% of all non-Hodgkin's lymphoma cases, with very poor treatment outcome as Western countries.

In Korea, the clinical information about patients with MCL is very scarce so far and does not reflect recent treatment patterns. Firstly, the incidence in Korea is relatively lower than that in Western countries, with only about 100 patients a year. Secondly, due to substandard national health insurance regulations in Korea, it was not until recently that ibrutinib for relapsed/refractory MCL was approved for coverage by the National Health Insurance. In this context, the study was designed to investigate the efficacy and safety of ibrutinib in patients with relapsed or refractory MCL in Korea.

研究设计

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

入排标准

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

入选标准

  • Patients with MCL diagnosed by a pathologist (based on the WHO 2017 classification)
  • mantle cell lymphoma
  • leukemic nonnodal mantle cell lymphoma
  • in situ mantle cell neoplasia
  • Aged ≥ 19 years
  • Relapsed or refractory patients treated with ibrutinib, including relapse after autologous stem cell transplantation

排除标准

  • Patients whose clinical and pathological data are not available
  • Patients who were not treated with ibrutinib

结局指标

主要结局

Progression free survival period

时间窗: Up to 3 years, From the date of diagnosis with MCL to the date of relapse/disease progression, or last follow-up date

Progression free survival period with ibrutinib

次要结局

  • Overall response rate(Up to 3 years, From the date of diagnosis with MCL to the date of death, or last follow-up date)

研究者

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

Won Seog Kim

MD, Ph.D, Professor of Hematology-Oncology

Samsung Medical Center

研究点 (1)

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