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

Peripheral T Cell Lymphoma Clinical Trial

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.

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04668690
Study type Interventional
Source CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Contact Huiqiang Huang, Docter
Phone +8613808885154
Email huanghq@sysucc.org.cn
Status Not yet recruiting
Phase Phase 3
Start date January 1, 2021
Completion date December 30, 2028
View Details
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