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

NCT04668690 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 193

Last updated 2025-05-31

No results posted yet for this study

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).

Conditions

  • Peripheral T Cell Lymphoma

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.

Sponsors & Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04668690 on ClinicalTrials.gov