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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRuijin Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Poor patient adherence

Investigator-deemed ineligibility for enrollment

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 3 trial groups
Group A: First line treatment cohort
Group B: Maintenance treatment cohort
Group C: Salvage treatment cohort

Trial outcomes

Primary outcomes

1

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

Time frame
up to 24 weeks after enrollment
2

Safety such as adverse events

Rate of adverse events (AEs)/ serious adverse events (SAEs) in patients with lymphoma receiving Golidocitinib therapy

Time frame
up to 4 weeks after the last dose

Secondary outcomes

1

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.

Time frame
Baseline up to data cut-off(up to approximately 3 years)
2

Progression-free survival

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.

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

Overall survival

Percentage of participants with complete or partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: