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.
Single group
SHR2554 combined with Liposomal Mitoxantrone
DrugPatients will receive 6 cycles of SHR2554 combined with liposomal mitoxantrone as induction therapy. All patients who achieve a complete response (CR) after induction therapy are eligible for transplantation. Patients achieving CR or partial response (PR), as well as those post-transplantation, may receive SHR2554 maintenance therapy in 28-day cycles. Maintenance therapy will continue until disease progression or other reasons for discontinuation. The maximum duration of SHR2554 administration in the maintenance phase will not exceed 24 months.
Incidence of Dose-Limiting Toxicities (DLT)
Adverse events (AE) defined as DLT events per protocol
Complete response (CR) rate
The proportion of subjects evaluated as complete response (CR) according to Lugano 2014 efficacy evaluation criteria
Objective response rate (ORR)
The proportion of subjects evaluated as complete response (CR) and partial response (PR) according to Lugano 2014 efficacy evaluation criteria
Duration of Response (DOR)
The time from the first assessment of CR/PR to the first assessment of PD or death from any cause in the subject
Duration of complete response (CR)
The time from the first assessment of CR to the first assessment of PD or death from any cause in the subject
Progression-free Survival (PFS)
From the time subjects were enrolled to the time of disease progression (in any way) or death from any cause.
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