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NCT Number: NCT07270861

Real-world Outcomes of Peripheral T-cell Lymphoma: A Multicenter Retrospective and Prospective Cohort Study

This study aims to characterize the epidemiology, clinicopathologic features, and survival outcomes of Chinese patients with PTCL; to develop and validate prognostic models to this population; to compare the real-world effectiveness and safety of alternative therapeutic strategies; to elucidate molecular mechanisms underlying treatment resistance and relapse; to identify actionable targets and predictive biomarkers.

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Key information

Conditions

Peripheral T-cell Lymphoma 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

Primary location

About this study

Due to disease heterogeneity and variability in clinical practice, establishing a large-scale Chinese PTCL database to characterize real-world treatment patterns and clinical outcomes is a critical undertaking. A retrospective cohort will define the clinical epidemiology of the disease, while a prospective cohort will delineate current treatment pathways and outcomes in routine practice and explore the molecular features of PTCL in the Chinese population, thereby providing evidence to support precision therapy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥18 years, with a histopathologic diagnosis of PTCL (any subtype per WHO 2016 classification of hematolymphoid neoplasms).
  • Cohort A: Patients diagnosed and treated at participating centers between 2010 and 2024.
  • Cohort B: Patients newly diagnosed from October 2025 onward.
  • Availability of basic diagnostic and treatment records .

Exclusion criteria

  • Indeterminate diagnosis or missing pathology report.
  • Patients diagnosed at an outside institution who did not receive their primary treatment and follow-up at a participating center.
  • Diagnoses of NK/T-cell lymphoma or primary cutaneous T-cell lymphomas.

Treatment and study plan

Observational

Other

Observational

Primary outcomes

  1. Distribution of PTCL Histological Subtypes according to WHO 2016 Classification

    Time frame: Baseline (at the time of enrollment or diagnosis)

    The number and percentage of participants diagnosed with each specific subtype of Peripheral T-Cell Lymphoma (e.g., PTCL-NOS, AITL, ALCL, ENKTL, etc.). Diagnosis is confirmed by pathological review based on the WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues (Revised 4th edition, 2017).

  2. Overall Survival (OS)

    Time frame: 5 year after diagnosis

    OS is defined as the time from the date of pathological diagnosis to the date of death from any cause. For patients who are lost to follow-up, survival time will be censored at the date of last contact.

  3. Progression-Free Survival (PFS)

    Time frame: 5 year after diagnosis

    PFS is defined as the time from the date of pathological diagnosis to the date of the first documented disease progression (PD) or death from any cause, whichever occurs first. Disease progression is assessed based on the investigator's evaluation of radiological and clinical data.

Secondary outcomes

  1. Frequency of Specific Genetic Mutations

    Time frame: Up to 5 years (at Baseline and at time of Disease Progression/Relapse)

    Evaluation of the number and percentage of participants carrying specific genetic alterations. Key biomarkers to be assessed include:

    Gene Mutations: TET2, DNMT3A, IDH2, RHOA, TP53, EZH2, and genes related to the PI3K-AKT pathway, assessed by Next-Generation Sequencing (NGS) or ct-DNA analysis. Correlations between these biomarkers and clinical outcomes (response, survival) will be analyzed.

  2. Expression levels of biomarker proteins

    Time frame: Up to 5 years (at Baseline and at time of Disease Progression/Relapse)

    Protein/Pathological Markers: Expression of PD-1/PD-L1, CD30, Ki-67 proliferation index, and EBV status, assessed by Immunohistochemistry (IHC) or In Situ Hybridization (ISH). Correlations between these biomarkers and clinical outcomes (response, survival) will be analyzed.

  3. Incidence of Treatment-Emergent Adverse Events (TEAEs) assessed by CTCAE v5.0

    Time frame: Up to 5 years

    Safety will be assessed by recording the number of participants with adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. This includes treatment-related deaths and incidence of second primary malignancies.

Study contacts

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

Chuanxu Liu, MD

CONTACT

[email protected]

008621-64175590 ext. 660103

Rong Tao, MD

CONTACT

[email protected]

008621-64175590 ext. 660103

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Collaborators

  • The First Affiliated Hospital of Zhengzhou University

Registry information

Official study title

A Multicenter, Non-interventional, Two-cohort Study to Describe Real-world Treatment Patterns and Outcomes in Patients With Peripheral T-cell Lymphoma

Important dates

Study start
2025
Primary completion
2030
Study completion
2035
First posted
Dec 8, 2025
Registry last updated
Mar 24, 2026

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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