NCT07785154招募中不适用
Post-Authorisation Registry of ELZONRIS (Tagraxofusp) in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 41
- 主要终点
- Number of Participants Achieving Complete Response After 3 Months (+/- 1 month) of Treatment
研究概览
简要总结
The main goal of this registry study is to investigate the effectiveness and safety of tagraxofusp in the treatment of adult participants with BPDCN in the real-world clinical practice setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Diagnosed with BPDCN, confirmed by hematopathology and biomarkers (inclusive of CD123, CD4, and CD56).
- •Planning to start treatment with tagraxofusp monotherapy for BPDCN at the time of, or within 6 months prior to, informed consent form (ICF) signature or has started treatment.
排除标准
- •Currently (or planning to) participating in another study or registry where BPDCN treatment outcomes are reported.
- •Participating in an interventional clinical trial at the time of ICF signature.
- •Known allergic reactions to components of tagraxofusp.
- •Note: Other protocol-specified criteria apply.
研究组 & 干预措施
Exploratory Cohort: Relapsed/Refractory
Adult participants with BPDCN prescribed tagraxofusp who are relapsed/refractory to prior treatment.
干预措施: Tagraxofusp (Drug)
Primary Cohort: Previously Untreated
Adult participants with BPDCN prescribed tagraxofusp as a first-line treatment.
干预措施: Tagraxofusp (Drug)
结局指标
主要结局
Number of Participants Achieving Complete Response After 3 Months (+/- 1 month) of Treatment
时间窗: Up to Month 4
Number of Participants Experiencing Capillary Leak Syndrome
时间窗: Up to Month 51
次要结局
- Number of Participants Who Receive Stem Cell Transplant (SCT)(Up to Month 66)
- Progression-free Survival (PFS)(Up to Month 66)
- Overall Survival (OS)(Up to Month 66)
- Best Overall Response (BOR)(Up to Month 66)
- Duration of Response (DOR)(Up to Month 66)
- Number of Participants with Dose Interruptions and/or Requiring Administration of Intravenous Albumin Supplementation(Up to Month 66)
- Number of Participants with Adverse Events of Special Interest (AESI)(Up to Month 66)
- Number of Participants with Adverse Events (AEs)(Up to Month 66)
- Number of Doses/Cycles of Tagraxofusp Administered(Up to Month 66)
研究者
研究点 (41)
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