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

NCT ID: NCT06963632

Last Updated: 2025-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-30

Study Completion Date

2027-12-31

Brief Summary

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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

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Conditions

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Peripheral T-cell Lymphoma (PTCL)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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First line treatment cohort

No interventions assigned to this group

Maintenance treatment cohort

No interventions assigned to this group

Salvage treatment cohort

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhao Weili

M.D. and Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Weili Zhao

Role: CONTACT

+86 02164370045

Other Identifiers

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golidocitinib-based treatment

Identifier Type: -

Identifier Source: org_study_id

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