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.
Overview
- Phase
- Phase 3
- Intervention
- Mitoxantrone Hydrochloride Liposome Injection
- Conditions
- Peripheral T Cell Lymphoma
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Enrollment
- 193
- Locations
- 1
- Primary Endpoint
- PFS assessed by the IRC
- Status
- Active, not recruiting
- Last Updated
- 11 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects fully understand and voluntarily participate in this study and sign informed consent;
- •Age ≥18, ≤75 years, no gender limitation;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2;
- •Histopathologically confirmed Peripheral T -cell Lymphoma (PTCL) according to World Health Organization (WHO) criteria (version 2016), with the subtypes as follows:
- •Peripheral T-cell lymphoma, unspecified (PTCL, NOS);
- •Angioimmunoblastic T-cell lymphoma (AITL);
- •ALK+ systematic anaplastic large T-cell lymphoma (ALCL, ALK+);
- •ALK-systematic anaplastic large T-cell lymphoma (ALCL，ALK-);
- •Extranobal NK/T cell lymphoma (nasal type) (NKTCL);
- •Other subtypes of PTCL which are appropriate to be enrolled in the opinion of the investigator.
Exclusion Criteria
- Not provided
Arms & Interventions
Experimental: Mitoxantrone Hydrochloride Liposome Injection
Patients with relapsed/refractory PTCL will receive Mitoxantrone Hydrochloride Liposome Injection every 28 days (a cycle) for a maximum of 8 cycles. The dose of Mitoxantrone Hydrochloride Liposome Injection is 20 mg/m2.
Intervention: Mitoxantrone Hydrochloride Liposome Injection
Active Comparator: Chidamide
Patients with relapsed/refractory PTCL will receive Chidamide 30 mg p.o., twice per week until disease progression.
Intervention: Chidamide
Outcomes
Primary Outcomes
PFS assessed by the IRC
Time Frame: Up to 48 months
PFS (progression-free survival) assessed by the Independent Review Committee (IRC)
Secondary Outcomes
- OS(Up to 48 months)
- TTR(Up to 48 months)
- DoR(Up to 48 months)
- DoRR(Up to 48 months)
- PFS assessed by investigators(Up to 48 months)
- ORR(Up to 48 months)
- CR(Up to 48 months)
- The incidence of AE and SAE(Up to 48 months)