Bendamustine Plus Rituximab for Mantle Cell Lymphoma: a Multicenter Retrospective Analysis(BR-MCL)
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Overall response rate,
研究概览
简要总结
This study with retrospective data collection does not entail sample size calculation. The study will involve patients who received bendamustine + rituximab for relapsed/refractory mantle cell lymphoma and meet the inclusion/exclusion criteria at each participating study site. Considering the incidence of mantle cell lymphoma in Korea and the number of participating sites, the expected sample size is approximately 40.
详细描述
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Inclusion criteria : Patients newly diagnosed with mantle cell lymphoma by a pathologist (based on the 2016 revision of the WHO classification) 1) mantle cell lymphoma 2) leukemic non-nodal mantle cell lymphoma 3) in situ mantle cell neoplasia
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Age ≥ 19 years
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Patients who received bendamustine + rituximab as initial therapy and patients who received bendamustine + rituximab for the treatment of relapsed/refractory condition are both included.
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Exclusion criteria :
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Patients whose clinical and pathological data are not available
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Patients who were not treated with a combination of bendamustine and rituximab
Data of patients who received bendamustine + rituximab for relapsed/refractory mantle cell lymphoma collected before the date of first submission of an IRB application for new project will be analyzed.
The aim is to publish the data analysis and study results before December 2020. The expected overall study period is until December 2020.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients newly diagnosed with mantle cell lymphoma by a pathologist (based on the 2016 revision of the WHO classification)
- •mantle cell lymphoma
- •leukemic non-nodal mantle cell lymphoma
- •in situ mantle cell neoplasia
- •Age ≥ 19 years
- •Patients who received bendamustine + rituximab as initial therapy and patients who received bendamustine + rituximab for the treatment of relapsed/refractory condition are both included.
排除标准
- •Patients whose clinical and pathological data are not available
- •Patients who were not treated with a combination of bendamustine and rituximab
结局指标
主要结局
Overall response rate,
时间窗: 2020.12.30
Overall response rate, including complete response and partial response
次要结局
- Duration of response(2020.12.30)
- Treatment-emergent adverse event(2020.12.30)
- Progression-free survival(2020.12.30)
- Prognostic factor(2020.12.30)
- Overall survival(2020.12.30)
研究者
Won Seog Kim
MD,phD,Division of hematology, Department of medicine
Samsung Medical Center