Clinical trial · Observational
A Real-world Study on Golidocitinib-based Therapeutic Regimens for the Treatment of Patients With Peripheral T-cell Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral T-cell Lymphoma (PTCL) | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- First line treatment cohort
- label
- Maintenance treatment cohort
- label
- Salvage treatment cohort
Primary outcomes (2)
- measure
- Objective Response Rate
- timeFrame
- up to 24 weeks after enrollment
- description
- Percentage of participants with complete or partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria during the treatment
- measure
- Safety such as adverse events
- timeFrame
- up to 4 weeks after the last dose
- description
- Rate of adverse events (AEs)/ serious adverse events (SAEs) in patients with lymphoma receiving Golidocitinib therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available