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);
Sun Yat-Sen University Cancer Center
Lead sponsor
CSPC Ouyi Pharmaceutical Co., Ltd.
Collaborator