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

StatusActive, Not Recruiting
PhasePhase 3
Started2021-04-13
View on ClinicalTrials.gov ↗

Amendment history

2025-05-27
Not Yet Recruiting→Active, Not Recruiting Study Status, Study Design, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Active, Not Recruiting
Start dateestimated 2021-01-01→confirmed 2021-04-13
Enrollment targetestimated 190→confirmed 193
Eligibility criteria+97 characters
[...] e controlled by oral hypoglycemic drugs or insulin therapy; The patients had a history of active bleeding within the previous 3 months before the screening; History of mental illness or history of drug abuse or depend [...]
2020-12-11
Original filing
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).
Trial Details
NCT Number NCT04668690
Lead Sponsor CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions Peripheral T Cell Lymphoma
Enrollment 193 participants
Start Date 2021-04-13
Primary Completion 2027-12-30 (estimated)
Study Completion 2028-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-05-31