NCT03526926已完成不适用
A Post-Marketing Observational Study of VYXEOS™ to Assess the Incidence of Infusion-Related Reactions in Adult Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 7
- 主要终点
- Infusion-Related Reactions on Day 1
研究概览
简要总结
The purpose of this observational study is to provide data on the incidence and severity of infusion-related reactions during and immediately following each infusion of VYXEOS during the first induction.
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
- •The decision to prescribe VYXEOS must have been made prior to enrollment in this study and based upon approved US indications and dosing: 44mg/m2 daunorubicin and cytarabine 100 mg/2 on Days 1, 3, and
- •Ability to understand and voluntarily give informed consent and understand the requirements of the registry.
- •Age ≥ 18 years.
- •Initiating VYXEOS therapy for the first time according to the current prescribing information.
- •Initiating VYXEOS therapy for the first time according to standard institutional practice.
排除标准
- •Prior treatment with VYXEOS.
- •Patients receiving any investigational agent other than VYXEOS (e.g., any drug or biologic agent or medical device that has not received approval in the US) or receiving VYXEOS for any indication not currently approved in the US.
研究组 & 干预措施
Vyxeos
A minimum of 50 patients who receive at least one infusion of prescribed VYXEOS.
干预措施: CPX-351 (Drug)
结局指标
主要结局
Infusion-Related Reactions on Day 1
时间窗: Day 1
The investigator will assess each AE and indicate if it as an infusion-related reaction.
次要结局
- Incidence of Treatment-emergent Adverse Events (TEAEs)(1 day after the last infusion)
- Incidence of Infusion-Related Reactions Occurring until One Day after the Last Infusion(1 day after the last infusion)
- Changes in Vital Signs(Up to 180 minutes after the start of infusion)
研究者
研究点 (7)
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