Peripheral T-cell Lymphoma (PTCL)
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Ruijin Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Voluntarily sign and acknowledge understanding of the Informed Consent Form 2. Clinically confirmed diagnosis of peripheral T-cell lymphoma 3. Inclusion of PTCL patients who initiated a Golidocitinib-based treatment regimen within the past 3 months 4. 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
Exclusion criteria
1. Poor patient adherence 2. Investigator-deemed ineligibility for enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | up to 24 weeks after enrollment | 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 | up to 4 weeks after the last dose | Rate of adverse events (AEs)/ serious adverse events (SAEs) in patients with lymphoma receiving Golidocitinib therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | Baseline up to data cut-off(up to approximately 3 years) | Percentage of participants with complete or partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria. |
| Duration of Response | Baseline up to data cut-off(up to approximately 3 years) | 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 | Baseline up to data cut-off(up to approximately 3 years) | 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. |
Contacts
Primary ContactWeili Zhao
Outcome results
None listed