NCT05173545

Clinical Pharmacokinetics of Mitoxantrone Hydrochloride Liposome Injection in Recurrent/Refractory Lymphoma Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Recurrent/Refractory Lymphoma

Interventions

Type	Name	Description
DRUG	Mitoxantrone Hydrochloride Liposome Injection	Every 28 days is a administration cycle, a total of 4 cycles.Until the subject's PD or intolerable or withdrawal (whichever occurs first). 5% Glucose Injection drugs dissolved in 250 ml, intravenous drip for 60 minutes.

Timeline

• Start date: 2019-07-29
• Primary completion: 2020-10-28
• Completion: 2020-10-28
• First posted: 2021-12-30
• Last updated: 2021-12-30

Locations

1 site across 1 country: China