A Real-world Study on Golidocitinib-based Therapeutic Regimens for the Treatment of Patients With Peripheral T-cell Lymphoma

Not yet recruiting

• Conditions: Peripheral T-cell Lymphoma (PTCL)

• Registration Number: NCT06963632
• Lead Sponsor: Ruijin Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-23
• Study Start: 2025-04-30
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-06
• Last Update Submitted: 2025-05-06
• Study First Posted: 2025-05-09
• Last Update Posted: 2025-05-09
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.