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ACTIVE NOT RECRUITING
NCT04668690
PHASE3

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

Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

View on ClinicalTrials.gov

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).

Official title: 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 PTCL.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

193

Start Date

2021-04-13

Completion Date

2028-12-30

Last Updated

2025-05-31

Healthy Volunteers

No

Interventions

DRUG

Mitoxantrone Hydrochloride Liposome Injection

Drug: Liposomal mitoxantrone hydrochloride (20 mg/m2) administered as an intravenous infusion on day 1 of each 28-day cycle.

DRUG

Chidamide

Drug: Chidamide tablet (30 mg) is given to the patients p.o. 30 minutes after breakfast, twice per week with 3-day intervals.

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China