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

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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Key information

Conditions

Peripheral T-cell Lymphoma (PTCL) Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Peripheral Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Voluntarily sign and acknowledge understanding of the Informed Consent Form
Clinically confirmed diagnosis of peripheral T-cell lymphoma
Inclusion of PTCL patients who initiated a Golidocitinib-based treatment regimen within the past 3 months
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

Poor patient adherence
Investigator-deemed ineligibility for enrollment

Treatment and study plan

Primary outcomes

Objective Response Rate

Time frame: 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

Time frame: 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 outcomes

Duration of Response

Time frame: 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

Time frame: 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

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Weili Zhao

CONTACT

[email protected]

+86 02164370045

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Acronym: JOYCE

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: May 9, 2025
Registry last updated: May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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