Clinical Pharmacokinetics of Mitoxantrone Hydrochloride Liposome Injection in Recurrent/Refractory Lymphoma Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pharmacokinetic indexes, Maximum concentration (Cmax,u)
研究概览
简要总结
This is a single-center, open, randomized parallel group design study to investigate the pharmacokinetic characteristics of Mitoxantrone Hydrochloride liposome injection in the treatment of relapsed/refractory lymphoma after the first administration, and the safety and efficacy.
详细描述
The study was divided into three dosage groups: 12 mg/m2, 16 mg/m2 and 20 mg/m2,and three dosage groups were randomly divided into parallel groups.Every 28 days is a administration cycle, a total of 4 cycles.Until the subject's PD or intolerable or withdrawal (whichever occurs first).
In the study before administration of the first cycle to cycle second will set up 16 blood points,to calculate the pharmacokinetic parameters of total mitoxantrone and free mitoxantrone after the first administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Mitoxantrone Hydrochloride Liposome Injection（12 mg/m2）
itoxantrone Hydrochloride Liposome Injection（12 mg/m2）
干预措施: Mitoxantrone Hydrochloride Liposome Injection (Drug)
Mitoxantrone Hydrochloride Liposome Injection（16 mg/m2）
itoxantrone Hydrochloride Liposome Injection（16 mg/m2）
干预措施: Mitoxantrone Hydrochloride Liposome Injection (Drug)
Mitoxantrone Hydrochloride Liposome Injection（20mg/m2）
itoxantrone Hydrochloride Liposome Injection（20 mg/m2）
干预措施: Mitoxantrone Hydrochloride Liposome Injection (Drug)
结局指标
主要结局
Pharmacokinetic indexes, Maximum concentration (Cmax,u)
时间窗: Up to 28 days
Maximum concentration (Cmax,u) of Mitoxantrone Hydrochloride Liposome
Pharmacokinetic indexes, Cmax Maximum concentration (Cmax)
时间窗: Up to 28 days
aximum concentration (Cmax) of Mitoxantrone Hydrochloride Liposome
Pharmacokinetic indexes, Tmax
时间窗: Up to 28 days
Time to Cmax (Tmax) of Mitoxantrone Hydrochloride Liposome
次要结局
- progression-free survival(PFS)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first（assessed up to 100 months）)