This is a single-arm, multicenter, Phase Ib/IIa study designed to explore the efficacy and safety of SHR2554 in combination with liposomal mitoxantrone for the treatment of patients with treatment-naive peripheral T-cell lymphoma (PTCL). The study is divided into a Phase Ib safety lead-in phase and a Phase IIa dose expansion phase.
Age ≥18 years old,regardless of gender;
Centrally confirmed histopathological/cytologic diagnosis of PTCL with the following subtypes:Peripheral T-cell lymphoma, not otherwise specified (PTCL, NOS);Follicular helper T (TFH) cell lymphoma of lymph nodes, including angioimmunoblastic, follicular, NOS; Enteropathy-associated T-cell lymphoma(EATL); Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL)and any other PTCL subtypes deemed by the investigator to be eligible for inclusion.
No prior anti-tumor therapy.
There must be at least one measurable or evaluable lesion that meets the Lugano 2014 criteria for lymphoma: Measurable lesion: Nodal lesions with major diameter greater than 1.5cm and minor diameter greater than 1.0cm as assessed by PET/CT or Computed Tomography (CT) and/or Magnetic Resonance Imaging (MRI); Or the length of extranodal lesions >1.0cm; 2)Evaluable lesions: PET-CT showed increased uptake in lymph nodes or extranodal regions (higher than liver) and imaging features consistent with lymphoma;
Prior treatment with epigenetic agents before enrollment;
Patients with a history of severe cardiac disease, history of radiation therapy to the mediastinal/pericardial region, cumulative anthracycline dose > 550 mg (doxorubicin equivalent), prior use of mitoxantrone, baseline left ventricular ejection fraction (LVEF) < 50%, or history of exposure to other cardiotoxic drugs;
History of other primary aggressive malignancies that are not in remission, or have been in remission for less than 3 years;
Primary central nervous system (CNS) lymphoma or secondary CNS involvement.