BESPONSA INJECTION 1MG SPECIAL INVESTIGATION (PEDIATRIC INVESTIGATION)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Occurrence of adverse events
研究概览
简要总结
The purpose of this study is to learn about the safety of BESPONSA for pediatric patients. .
BESPONSA is approved for treatment of relapsed or refractory CD22-positive acute lymphocytic leukemia for pediatric patients. A type of leukemia (blood cancer) that comes on quickly and is fast growing. In acute lymphocytic leukemia, there are too many lymphoblasts (early-stage white blood cells) in the blood and bone marrow. Also called ALL.
The registration criteria for this study are:
- Never used BESPONSA before
- <18 years at the start of treatment with BESPONSA
All patients in this study will receive BESPONSA according to the prescriptions.
Patients will be followed up as follow
- Treatment phase: From the day of treatment initiation (Day 1) to Day 28 post-treatment to collect information on safety (e.g., adverse events).
- Follow-up phase: From Day 29 post-treatment to Week 52 to collect information on VOD/SOS.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with relapsed or refractory CD22-positive ALL
- •Patients who have never used BESPONSA before
- •Patients aged <18 years at the start of treatment with BESPONSA
排除标准
- 未提供
结局指标
主要结局
Occurrence of adverse events
时间窗: Up to 28 days after the last administration
Risk factors related to the onset of venoocclusive liver disease/sinusoidal obstruction syndrome
时间窗: Up to 52 weeks
次要结局
未报告次要终点