Evaluation of the Safety and Efficacy of SHR2554 as Maintenance Therapy after first-line systemic treatment in patients with peripheral T-cell lymphoma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
SHR2554 orally twice daily
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
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.
Time frame: 2 years
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.
Time frame: 1year,2year
Rate of patients who were PR at enrollment converting to CR
The Rate of patients who were PR at enrollment converting to CR
Time frame: Time from the first dose to any events, assessed up to 12 months
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.
Time frame: Time from the first dose to disease progression or death, assessed up to 12months
Duration of Response (DoR)
The interval from the initial documentation of response (CR or PR) to the first documentation of disease progression or death.
Time frame: From the date response is first documented to the date of disease progression or death, up to 36 months
Progression-Free Survival (PFS)
The length of time during and after treatment that the participant lives without progression of the disease, as assessed by 2014 Lugano criteria.
Time frame: Time from the first dose to disease progression or death, assessed up to 36 months
Overall Survival (OS)
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The length of time from the start of treatment until death from any cause.
Time frame: Time from the first dose to death from any cause, assessed up to 36 months
Incidence of Treatment-Related Adverse Events (Safety and Tolerability)
The incidence, type, and severity of adverse events (graded according to CTCAE v5.0), and their relationship to the study treatment.
Time frame: Up to 12 months