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Not yet recruiting NCT06963632

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

Observational Peripheral T-cell Lymphoma (PTCL)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Peripheral T-cell Lymphoma (PTCL). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Objective Response Rate [Time frame: up to 24 weeks after enrollment]
  • Safety such as adverse events [Time frame: up to 4 weeks after the last dose]
Secondary outcome measures (3)
  • Duration of Response [Time frame: Baseline up to data cut-off(up to approximately 3 years)]
  • Progression-free survival [Time frame: Baseline up to data cut-off(up to approximately 3 years)]
  • Overall survival [Time frame: Baseline up to data cut-off(up to approximately 3 years)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06963632 · golidocitinib-based treatment

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗