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

NCT06963632 | Not Yet Recruiting DMC

• 1 other identifier: golidocitinib-based treatment
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peripheral T-cell Lymphoma (PTCL)

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Duration of Response

  Baseline up to data cut-off(up to approximately 3 years)

• Progression-free survival

  Baseline up to data cut-off(up to approximately 3 years)

• Overall survival

  Baseline up to data cut-off(up to approximately 3 years)

Study Arms (3)

First line treatment cohort

Maintenance treatment cohort

Salvage treatment cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with peripheral T-cell lymphoma who would benefit from golicitinib

You may qualify if:

• Voluntarily sign and acknowledge understanding of the Informed Consent Form
• Clinically confirmed diagnosis of peripheral T-cell lymphoma
• 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

You may not qualify if:

• Poor patient adherence
• Investigator-deemed ineligibility for enrollment

Sponsors & Collaborators

• Ruijin Hospital: lead

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Weili Zhao

CONTACT

+86 02164370045; zwl_trial@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. and Ph.D

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 9, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share