NCT03776279

A Study of Liposome-entrapped Mitoxantrone Hydrochloride Injection in Relapsed/Refractory Peripheral T-cell Lymphoma and NK/T-cell Lymphoma

Single-arm, Open and Multi-center Phase II Study of Liposome-entrapped Mitoxantrone Hydrochloride Injection in Relapsed/Refractory Peripheral T-cell Lymphoma and NK/T-cell Lymphoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 106 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open, multi-center, phase II study to evaluate the efficacy and safety of Mitoxantrone Hydrochloride Liposome Injection in Relapsed or refractory peripheral t-cell and NK/T-cell lymphoma.

Detailed description

The dosage regimen of Liposome-entrapped Mitoxantrone is multi-cycle 20mg/m2 intravenous infusion. Every 4 weeks is a treatment cycle, with administration on the first day of each cycle. End-of-treatment visit will be made to the subjects within 4 weeks after the end of the last administration. Progression-free survival (PFS) follow-up will be conducted to the subjects in stable or improved condition after treatment and the subjects with early termination of treatment due to intolerance in Week 8 after the last administration of study drug, and thereafter once every 8 weeks until PD, death, withdrawal of informed consent form (ICF), starting another new treatment or end of the entire study (whichever occurs first). Meanwhile, overall survival (OS) follow-up will also be conducted to the subjects with PD and starting another new treatment once every 8 weeks until death, withdrawal of ICF or end of the entire study (whichever occurs first).

Conditions

• Relapsed or Refractory Peripheral T-cell and NK/T-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Mitoxantrone Hydrochloride Liposome Injection	Mitoxantrone Hydrochloride Liposome Injection 20 mg/m2 will be infused intravenously once over 60min in 250 ml 5％ glucose injection on the first day during a treatment phase of 4 weeks.

Timeline

• Start date: 2018-04-02
• Primary completion: 2020-12-30
• Completion: 2020-12-30
• First posted: 2018-12-14
• Last updated: 2018-12-14

Locations

1 site across 1 country: China