This real-world study aims to evaluate the safety and efficacy of golidocitinib-based treatment regimens in patients with peripheral T-cell lymphoma (PTCL), without intervention in the selection of therapeutic strategies. A total of 1,000 PTCL patients are planned to be enrolled. After screening, eligible participants meeting the inclusion and exclusion criteria will be assigned to one of three predefined cohorts: Cohort 1: Treatment-naïve patients with PTCL or NK/T-cell lymphoma. Cohort 2: Patients receiving maintenance therapy following remission after first-line induction treatment for PTCL. Cohort 3: Patients with relapsed or refractory PTCL or relapsed/refractory NK/T-cell lymphoma. There is no cap on the number of participants in each cohort.
Study Type
OBSERVATIONAL
Enrollment
1,000
Objective Response Rate
Percentage of participants with complete or partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria during the treatment
Time frame: up to 24 weeks after enrollment
Safety such as adverse events
Rate of adverse events (AEs)/ serious adverse events (SAEs) in patients with lymphoma receiving Golidocitinib therapy
Time frame: up to 4 weeks after the last dose
Duration of Response
Applicable to complete or partial response participants. DoR was defined as the time from the first documented date of complete or partial response until the date of the disease progression or death from any causes.
Time frame: Baseline up to data cut-off(up to approximately 3 years)
Progression-free survival
Progression-free survival was defined as the time from the date of randomization until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
Time frame: Baseline up to data cut-off(up to approximately 3 years)
Overall survival
Percentage of participants with complete or partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Time frame: Baseline up to data cut-off(up to approximately 3 years)
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