To evaluate the safety of mitoxantrone hydrochloride liposome combined with enlonstobart in the treatment of relapsed or refractory peripheral T-cell lymphoma, to determine the optimal dosage of mitoxantrone hydrochloride liposome within the combination regimen, and to assess the efficacy of the combined therapy.
Peripheral T-cell lymphoma, not otherwise specified (PTCL, NOS);
Systemic anaplastic large cell lymphoma (ALK+ and ALK-);
Follicular helper T (TFH) cell lymphoma of lymph nodes, including angioimmunoblastic, follicular, NOS;
and any other PTCL subtypes deemed by the investigator to be eligible for inclusion.
Patients with hemophagocytic lymphohistiocytosis;
Patients with active infection or with obvious B symptoms and high fever should be excluded according to the comprehensive judgment of the investigators;
Failure to achieve CR or PR after previous treatment with mitoxantrone or mitoxantrone liposome, or relapse within 6 months after treatment;
Prior treatment with anthracyclines or anthraquinones and cumulative dose of doxorubicin > 550 mg/m2 (liposomal doxorubicin > 2000 mg/m2, epirubicin > 1000 mg/m2, pirarubicin > 1000 mg/m2, mitoxantrone > 160 mg/m2);
Single group
Mitoxantrone Hydrochloride Liposome & Enlonstobart
DrugMitoxantrone hydrochloride liposome: ①Phase Ib：16 mg/m2、20 mg/m2 ，D1，q4w; ②Phase II：RP2D, D1，q4w, Up to 6 cycles Enlonstobart: 360mg，D1，q4w (The maintenance treatment phase is q3w), Up to 1 year
Phase Ib: Dose limited toxicities (DLTs)
Adverse events (AE) defined as DLT events per protocol
Phase Ib: Recommended Phase II Dose (RP2D)
RP2D based on Phase Ib results
Phase II: Objective response rate (ORR)
Response is assessed according to the 2014 lugano criteria
Complete response rate (CRR)
Response is assessed according to the 2014 lugano criteria
Disease control rate (DCR)
Response is assessed according to the 2014 lugano criteria
Progression-free survival（PFS）
From the time subjects were enrolled to the time of disease progression (in any way) or death from any cause.
Overall survival (OS)
From the date of inclusion to date of death, irrespective of cause.
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Sun Yat-Sen University Cancer Center
Lead sponsor
CSPC Ouyi Pharmaceutical Co., Ltd.
Collaborator
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