Evaluation of the Safety and Efficacy of SHR2554 as Maintenance Therapy after first-line systemic treatment in patients with peripheral T-cell lymphoma
Age ≥18 years old
Histologically confirmed PTCL,including PTCL NOS, ALCL, nTFHL,MEITL,ENKTL etc. according to WHO 2022 criteria.
Previously received first-line systemic induction therapy and achieved CR/PR; Auto-transplantation or allo-transplantation are allowed.
A measurable or evaluable disease at the time of first diagnosis of PTCL (any nodes/nodal masses>1.5 cm in longest diameter (LDi) or extralymphatic sites of disease >1.0 cm in LDi)
cutaneous T cell lymphoma
Has a prior malignancy other than the malignancies under study within 3 years without relieve
Participants with a presence of central nerves invasion
Known sensitivity or allergy to investigational product
Single group
SHR2554 Tablets
DrugSHR2554 orally twice daily
2 years PFS
The 2-year rate of during and after treatment that the participant lives without progression of the disease, as assessed by 2014 Lugano criteria.
1-year and 2-year DFS rates for patients who were in CR at enrollment
The rate of 1-year and 2-year that the participant lives without disease, as assessed by 2014 Lugano criteria.
Rate of patients who were PR at enrollment converting to CR
The Rate of patients who were PR at enrollment converting to CR
Complete Response Rate (CR)
The proportion of participants who achieve a complete response (CR) during the treatment period, as assessed by the 2014 Lugano criteria using FDG-PET imaging.
Duration of Response (DoR)
The interval from the initial documentation of response (CR or PR) to the first documentation of disease progression or death.
Minimal Residual Disease (MRD)-Negative Rate
The proportion of patients who achieve minimal residual disease negativity at the completion of treatment.
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