Prospective Cohort Study for Genomic Evaluation in Patients With Diffuse Large B Cell Lymphoma After First Relapse/Progression
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Next generation sequencing with tumor tissue
研究概览
简要总结
DLBCL has the highest frequency out of all lymphoid malignancies. With the recent development of antitumor agents targeting intracellular/extracellular cell signaling pathways, patients have access to various treatment options after relapse. Therefore, for the purpose of developing effective treatment strategies, large-scale genomic data accumulation is necessary to understand the mechanism of relapse and refractory state of DLBCL.
详细描述
- To understand the mechanism of relapse by genome sequencing with tissues/blood obtained at diagnosis and relapse in patients with diffuse B cell lymphoma who relapsed after standard chemotherapy, to evaluate their response and survival following a salvage therapy depending on the genomic sequencing results, and to understand the prognostic or predictive value of genomic mutation.
- To understand the predictive value of genetic information with regard to the response to salvage chemotherapy and survival outcome in patients with newly diagnosed/relapsed or refractory large B cell lymphoma
- To determine the association between gene mutation, treatment response and prognosis in relapsed/refractory diffuse large B cell lymphoma (DLBCL), and to develop a clinically applicable platform by establishing a genetic data register based on prospective studies
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathologically confirmed DLBCL
- •DLBCL who relapsed or were refractory to first-line treatment with rituximab-based immunotherapy
- •Available for genomic analysis of tissues both at diagnosis (paraffin-embedded and stored) and at relapse (paraffin-embedded)
- •Aged ≥18 years
- •Written informed consent for participation in the prospective cohort study
- •Written informed consent to peripheral blood collection and genetic testing of human tissues
排除标准
- •No lymphoid malignancy, e.g. myeloid leukemia
- •Any of the following lymphoid malignancies:
- •Plasma cell dyscrasia, amyloidosis
- •Hodgkin lymphoma
- •Subtypes of B cell non-Hodgkin lymphoma, other than DLBCL
- •T or NK(Natural Killer) cell non-Hodgkin lymphoma
- •Other diseases in the WHO(World Health Organization) classification of lymphoid malignancies
- •Experienced a relapse before
- •Insufficient or no tissue sample at diagnosis for genomic analysis
- •Can not understand or provide written informed consent
- •Who do not provide written informed consent to blood collection and genetic testing
结局指标
主要结局
Next generation sequencing with tumor tissue
时间窗: 2-year follow-up from the end of the enrollment
To understand the mechanism of relapse, targeted sequencing based on HemaScan panel including the essential genes (including 425 whole exome).
Next generation sequencing with blood
时间窗: 2-year follow-up from the end of the enrollment
To understand the mechanism of relapse, targeted sequencing based on HemaScan panel including the essential genes (including 425 whole exome).
次要结局
- Data which included salvage chemotherapy.(2-year follow-up from the end of the enrollment)
- Data which included survival outcome.(2-year follow-up from the end of the enrollment)
研究者
Won Seog Kim
Principal Investigator
Samsung Medical Center