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

Phase 1

Completed

• Conditions: Recurrent/Refractory Lymphoma
• Interventions: Drug: Mitoxantrone Hydrochloride Liposome Injection

• Registration Number: NCT05173545
• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Brief 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.

Study Timeline

• Study Start: 2019-07-29
• Study First Submitted: 2019-07-31
• Primary Completion: 2020-10-28
• Study Completion: 2020-10-28
• Status Verified: 2021-11
• Study First Submitted QC: 2021-12-12
• Last Update Submitted: 2021-12-12
• Study First Posted: 2021-12-30
• Last Update Posted: 2021-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mitoxantrone Hydrochloride Liposome Injection（12 mg/m2）	Mitoxantrone Hydrochloride Liposome Injection	itoxantrone Hydrochloride Liposome Injection（12 mg/m2）
Mitoxantrone Hydrochloride Liposome Injection（16 mg/m2）	Mitoxantrone Hydrochloride Liposome Injection	itoxantrone Hydrochloride Liposome Injection（16 mg/m2）
Mitoxantrone Hydrochloride Liposome Injection（20mg/m2）	Mitoxantrone Hydrochloride Liposome Injection	itoxantrone Hydrochloride Liposome Injection（20 mg/m2）

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic indexes, Maximum concentration (Cmax,u)	Up to 28 days	Maximum concentration (Cmax,u) of Mitoxantrone Hydrochloride Liposome
Pharmacokinetic indexes, Cmax Maximum concentration (Cmax)	Up to 28 days	aximum concentration (Cmax) of Mitoxantrone Hydrochloride Liposome
Pharmacokinetic indexes, Tmax	Up to 28 days	Time to Cmax (Tmax) of Mitoxantrone Hydrochloride Liposome

Secondary Outcome Measures

Name	Time	Method
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）	progression-free survival(PFS) of Mitoxantrone Hydrochloride Liposome

Trial Locations

Locations (1)

Guizhou Cancer Hospita; 🇨🇳 Guiyang, Guizhou, China