drugset / Trial / NCT04668690

Clinical Study of Mitoxantrone Hydrochloride Liposome Injection vs. Chidamide in Patients With Relapsed/Refractory PTCL

NCT04668690

Phase 3 Active not recruiting 193 enrolled CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized, open-label, active controlled, multi-center, phase 3 clinical study to compare the efficacy and safety of Mitoxantrone Hydrochloride Liposome Injection with Chidamide in patients with relapsed/refractory Peripheral T Cell Lymphoma (PTCL).

Timeline

Start
2021-04-13
Primary completion
2027-12-30
Completion
2028-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Mitoxantrone Hydrochloride Liposome Injection Unknown 20 mg/m2 Intravenous
Comparator Tucidinostat Small molecule 30 mg Oral