About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily sign and acknowledge understanding of the Informed Consent Form
Clinically confirmed diagnosis of peripheral T-cell lymphoma
Inclusion of PTCL patients who initiated a Golidocitinib-based treatment regimen within the past 3 months
Compliance with clinical management and provision of disease-related historical medical information required for the study, including but not limited to medical records, treatment history, and prior/prescribed therapeutic regimens
Disqualifiers
Poor patient adherence
Investigator-deemed ineligibility for enrollment
Trial population
Patients with peripheral T-cell lymphoma who would benefit from golicitinib
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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
Safety such as adverse events
Rate of adverse events (AEs)/ serious adverse events (SAEs) in patients with lymphoma receiving Golidocitinib therapy
Secondary outcomes
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.
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.
Overall survival
Percentage of participants with complete or partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: