Retrospective Study of Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Treated With Chemotherapy Agents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 67
- 主要终点
- Duration of Response
研究概览
简要总结
The main goal of this study is to investigate the effectiveness and safety of chemotherapy agents in the treatment of participants with BPDCN and to provide comparator arm data to the prospective ELZONRIS registry study (STML-401-0521).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Alive, deceased, or unreachable participants (as permitted by local regulation), aged ≥18 years at the start of first-line treatment for BPDCN, and treated with chemotherapy regimens (at a minimum) as first-line treatment for BPDCN from May 2016
- •Diagnosed with BPDCN, based on clinical, laboratory, and imaging (where performed per institutional practice) assessments, with a demonstration of a specific immunophenotype (either by immunohistochemistry or flow cytometry), particularly CD4, CD56, and CD123
- •Participants (or their legally authorized representatives) who have signed the informed consent and privacy form, where required as per local regulation
排除标准
- •Participant has received an investigational agent as first-line therapy for BPDCN
- •Participant has received first-line therapy for BPDCN in an interventional clinical trial
研究组 & 干预措施
Chemotherapy
Adult participants with BPDCN who have been treated with chemotherapy regimens (at a minimum) as first-line treatment from May 2016.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Duration of Response
时间窗: Baseline through Month 18
Real-world Progression-free Survival
时间窗: Baseline through Month 18
Objective Response Rate
时间窗: Baseline through Month 18
Composite Compete Response
时间窗: Baseline through Month 18
Number of Participants Bridged to Stem Cell Transplant
时间窗: Baseline through Month 18
Overall Survival
时间窗: Baseline through Month 18
Number of Participants with Treatment-emergent Adverse Events
时间窗: Baseline through Month 18
Number of Participants Requiring Transfusions
时间窗: Baseline through Month 18
Duration of Treatments Received and Hospitalization
时间窗: Baseline through Month 18
Composite Complete Response
时间窗: Baseline through Month 18
次要结局
- Time to Next Treatment(Baseline through Month 26)
- Number of Different First-line Treatment Regimens and Sequences Received(Baseline through Month 26)