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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First line treatment cohort | |||
| Maintenance treatment cohort | |||
| Salvage treatment cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | up to 4 weeks after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to data cut-off(up to approximately 3 years) |
| Progression-free survival |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with peripheral T-cell lymphoma who would benefit from golicitinib
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weili Zhao | Contact | +86 02164370045 | zwl_trial@163.com |
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| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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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. |
| 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. | Baseline up to data cut-off(up to approximately 3 years) |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |