NCT04668690

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

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.

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 193 (actual)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This study is a randomized, open-label, positive control, multicenter, phase Ⅲ study to compare the efficacy and safety of Mitoxantrone Hydrochloride Liposome Injection with Chidamide in patients with relapsed/refractory Peripheral T Cell Lymphoma (PTCL). The eligible patients will be randomly assigned to the experimental and control groups in a 1:1 ratio. The patients in experimental group will receive Mitoxantrone Hydrochloride Liposome Injection (20 mg/m2) once every 28 days for a maximum of 6-8 cycles. Patients in the control group will be treated with Chidamide (30 mg) twice per week with 3-day intervals until disease progression. Patients in the control group who had confirmed disease progression will have the option to switch to the liposomal mitoxantrone hydrochloride treatment. Patients will receive treatment until the completion of 6-8 cycles of treatment (this applies only to the experiment group), disease progression, intolerable toxicity, death, loss to follow-up, withdrawal (patient's decision or investigator's decision), whichever comes first. All patients will have post-treatment follow-up for disease status until disease progression/recurrence, initiation of new antitumor therapy, or being lost to follow-up.

Conditions

• Peripheral T Cell Lymphoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-04-13
• Primary completion: 2027-12-30
• Completion: 2028-12-30
• First posted: 2020-12-16
• Last updated: 2025-05-31

Locations

1 site across 1 country: China