drugset
drugset / Trial / NCT04548700

Liposomal Mitoxantrone Hydrochloride Injection,Cyclophosphamide, Vincristine and Prednisone in the Treatment of PTCL

NCT04548700 ↗

Phase 1 Terminated 38 enrolled CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This is a multicentre, open-label, single-arm, phase Ib clinical study to evaluate the safety, tolerability, efficacy and pharmacokinetics of liposomal mitoxantrone hydrochloride in combination with Cyclophosphamide, Vincristine and Prednisone in the frontline treatment of patients with peripheral T cell lymphoma (PTCL).

Timeline

Start
2020-12-24
Primary completion
2023-06-30
Completion
2023-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Mitoxantrone Small molecule 12 mg/m2 Intravenous
Subject Mitoxantrone Small molecule 15 mg/m2 Intravenous
Subject Mitoxantrone Small molecule 18 mg/m2 Intravenous
Background Cyclophosphamide Other / unclassified 750 mg/m2 Intravenous
Background Prednisone Other / unclassified 100 mg Oral
Background Vincristine Small molecule 1.4 mg/m2 Intravenous

Indications

peripheral T-cell lymphoma, not otherwise specified