A Study of Liposome-entrapped Mitoxantrone Hydrochloride Injection in Relapsed/Refractory Peripheral T-cell Lymphoma and NK/T-cell Lymphoma
- Conditions
- Relapsed or Refractory Peripheral T-cell and NK/T-cell Lymphoma
- Interventions
- Registration Number
- NCT03776279
- Lead Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Brief Summary
This is a single-arm, open, multi-center, phase II study to evaluate the efficacy and safety of Mitoxantrone Hydrochloride Liposome Injection in Relapsed or refractory peripheral t-cell and NK/T-cell lymphoma.
- Detailed Description
The dosage regimen of Liposome-entrapped Mitoxantrone is multi-cycle 20mg/m2 intravenous infusion. Every 4 weeks is a treatment cycle, with administration on the first day of each cycle. End-of-treatment visit will be made to the subjects within 4 weeks after the end of the last administration. Progression-free survival (PFS) follow-up will be conducted to the subjects in stable or improved condition after treatment and the subjects with early termination of treatment due to intolerance in Week 8 after the last administration of study drug, and thereafter once every 8 weeks until PD, death, withdrawal of informed consent form (ICF), starting another new treatment or end of the entire study (whichever occurs first). Meanwhile, overall survival (OS) follow-up will also be conducted to the subjects with PD and starting another new treatment once every 8 weeks until death, withdrawal of ICF or end of the entire study (whichever occurs first).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 106
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Mitoxantrone Hydrochloride Liposome Injection Mitoxantrone Hydrochloride Liposome Injection 4 weeks is a treatment cycle, and the first day of each cycle is administered.
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) >4weeks The percentage of complete response (CR) and partial response (PR) in all the enrolled subjects from the date of the first administration (calculated by the optimum response during the entire study period)
- Secondary Outcome Measures
Name Time Method Duration of Response(DoR) >3 months The duration from achieving effective treatment (CR or PR recorded for the first time) until definite relapse or progression for the first time.
Progression-free survival(PFS) 3 years The duration from the first administration date until lymphoma progression (PD evaluated by imaging diagnosis) date or all-cause death date (whichever occurs first).
Overall survival(OS) 3 years The duration from the first administration date until all-cause death date.
Disease control rate(DCR) 3 years The percentage of CR and PR in all the enrolled subjects from the date of the first administration, including the subjects with CR, PRC or SD
Trial Locations
- Locations (1)
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China