An Observational Study of Blinatumomab Safety and Effectiveness, Utilization, and Treatment Practices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 279
- 试验地点
- 80
- 主要终点
- Proportion of Blincyto administrations with medication errors
研究概览
简要总结
An observational study of blinatumomab safety and effectiveness, utilisation, and treatment practices.
详细描述
The primary objective of this study is to characterize the safety of Blincyto in routine clinical practice. Blincyto effectiveness, medication errors, and utilisation; and select healthcare resource use while using Blincyto will also be described. Safety and effectiveness of Blincyto in specified subgroups of patients will also be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medical records of patients initiating Blincyto after country-specific reimbursement in routine clinical practice will be eligible for extraction.
排除标准
- •Medical records of patients who have participated in Blincyto clinical trials will be excluded since their treatment will be prescribed by the study protocol unless the patient is receiving new Blincyto treatment outside the clinical trial.
- •Medical records of patients participating in other Amgen non-interventional prospective studies in which safety endpoints are collected will be excluded.
- •Medical records of patients who have received Blincyto via an expanded access/compassionate use program will be excluded.
- •In countries where patient informed consent is required for access to their medical records, any patient who does not provide informed consent will be excluded.
结局指标
主要结局
Proportion of Blincyto administrations with medication errors
时间窗: Estimated to be 100 days
Proportion of Blincyto administrations with medication errors, defined as an unintended failure in the drug treatment process that leads to, or has the potential to lead to, harm to the patient, identified through medical records. Types of medication errors will also be described * incorrect Blincyto dose administered/prepared (eg. drug concentration, device issues, treatment according to SmPC) * does not include treatment related to dexamethasone.
Proportion of patients with specified AEs as mentioned in description
时间窗: Estimated to be 100 days
* Neurological adverse events * Opportunistic infections * Cytokine release syndrome
Time to onset of first specified AEs
时间窗: Estimated to be 100 days
Time to onset of first specified AEs.
Summary of duration of specified AEs as detailed in the description (all events and resolved/recovered events)
时间窗: Estimated to be 100 days
Summary of duration of specified AEs (all events and resolved/recovered events) * Neurological adverse events * Opportunistic Infections
次要结局
- Blincyto utilisation: Total number of days of administration(Estimated to be 100 days)
- Proportion of patients receiving allogeneic HSCT amongst patient sub-groups(Estimated to be 100 days)
- Blincyto utilisation: Number of cycles initiated(Estimated to be 100 days)
- Disease Free Survival (DFS) time(Estimated to be 100 days)
- Blincyto utilisation: Number of bag changes(Estimated to be 100 days)
- Blincyto utilisation: Proportion of patients with treatment changes(Estimated to be 100 days)
- Select healthcare resource use: Proportion of treatment days that were inpatient(Estimated to be 100 days)
- Select healthcare resource use: Incidence of hospitalization not related to infusion(Estimated to be 100 days)
- Blincyto utilisation: Proportion of patients with dose step-up on Day 8(Day 8)
- Proportion of patients with AEs as detailed in the description(Estimated to be 100 days)
- Proportion of patients achieving CR/CRh*/CRi amongst patient sub-groups(Estimated to be 100 days)
- Overall survival (OS) time amongst patient sub-groups(Estimated to be 100 days)
- Proportion of patients with MRD achieving CR/CRh*/CRi within 2 cycles of Blincyto(Estimated to be 100 days)
- Blincyto utilisation: Number of completed cycles(Estimated to be 100 days)
- Select healthcare resource use: Total number of days of inpatient Blincyto treatment(Estimated to be 100 days)
- Select healthcare resource use: Number of bag changes in each setting(Estimated to be 100 days)
- Proportion of patients achieving Complete Remission overall and amongst patient sub-groups(Estimated to be 100 days)
- 1-year and 100-day mortality proportion after allogeneic HSCT amongst patient sub-groups(Estimated to be 100 days)
- Relapse-free survival (RFS) time amongst patient sub-groups(Estimated to be 100 days)
- Select healthcare resource use: Length of hospital stay not related to infusion(Estimated to be 100 days)