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Clinical and Biological Cohort Study of EBV-Positive T/NK-Cell Lymphoproliferative Diseases

ConditionsExtranodal NK/T-cell LymphomaAggressive NK-Cell LeukemiaSystemic Chronic Active Epstein-Barr Virus DiseaseEpstein-Barr Virus-Positive Nodal T/NK-Cell LymphomaEpstein-Barr Virus-Positive T/NK-Cell Lymphoproliferative Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRong Tao

About this trial

This is a multicenter, non-interventional, ambidirectional cohort study of Epstein-Barr virus-positive T/NK-cell lymphoproliferative diseases. The study consists of a retrospective clinical cohort of 500 consecutively diagnosed patients with extranodal NK/T-cell lymphoma and a prospective clinical-biological cohort of 1,000 newly diagnosed patients with extranodal NK/T-cell lymphoma, aggressive NK-cell leukemia, systemic chronic active Epstein-Barr virus disease of T/NK-cell type, or Epstein-Barr virus-positive nodal T/NK-cell lymphoma.

The study will characterize clinical features, treatment pathways, response, relapse or progression patterns, and long-term survival. The prospective cohort will additionally undergo standardized collection of peripheral blood and optional tumor tissue specimens at predefined clinical time points. Clinical, molecular, viral, and immune biomarkers will be evaluated for their associations with treatment response, treatment failure, disease progression, and survival. No treatment is assigned by the study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older.

Newly diagnosed Epstein-Barr virus-positive T/NK-cell lymphoproliferative disease meeting World Health Organization diagnostic criteria.

For the retrospective cohort: diagnosis of extranodal NK/T-cell lymphoma between January 1, 2017 and December 31, 2025 at a participating center.

Extranodal NK/T-cell lymphoma;

Disqualifiers

For the retrospective cohort: no usable survival follow-up information, inability to confirm survival status, or inability to calculate the principal survival outcomes.

For the prospective cohort: unwillingness or inability to participate in protocol-defined longitudinal clinical follow-up.

Trial population

Adults aged 18 years or older with a newly diagnosed Epstein-Barr virus-positive T/NK-cell lymphoproliferative disease meeting World Health Organization diagnostic criteria. The retrospective cohort includes consecutive hospitalized patients with extranodal NK/T-cell lymphoma diagnosed from 2017 through 2025. The prospective cohort includes consecutive newly diagnosed patients with extranodal NK/T-cell lymphoma or one of the prespecified rare Epstein-Barr virus-positive T/NK-cell disease entities from 2026 through 2030.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

1,500 Participants
are grouped into 2 trial groups
Group A: Retrospective NKTCL Cohort
Group B: Prospective EBV-Positive T/NK Disease Cohort

Trial outcomes

Primary outcomes

1

Overall Survival

Overall survival is defined as the time from the date of initial diagnosis to death from any cause. Participants who are alive will be censored at the date on which their survival status was last confirmed.

Time frame
From initial diagnosis to death or last confirmed follow-up, assessed for up to 10 years.
2

Progression-Free Survival

Progression-free survival is defined as the time from the date of initial diagnosis to the first documented disease progression, disease relapse, or death from any cause, whichever occurs first. Participants without an event will be censored at the date of the last assessment confirming absence of progression.

Time frame
From initial diagnosis to progression, relapse, death, or last disease assessment, assessed for up to 10 years.

Secondary outcomes

1

Objective Response Rate

The proportion of response-evaluable participants who achieve a best response of complete response or partial response during first-line treatment. The response-evaluable population includes participants who undergo at least one formal response assessment.

Time frame
From initiation of first-line treatment through the first-line end-of-treatment assessment, assessed for up to 24 months.
2

Complete Response Rate

The proportion of response-evaluable participants who achieve complete response during first-line treatment.

Time frame
From initiation of first-line treatment through the first-line end-of-treatment assessment, assessed for up to 24 months.
3

Grade 3 or Higher Adverse Events

The proportion of participants experiencing grade 3 or higher adverse events during systemic anticancer treatment, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

Time frame
During each treatment line, from treatment initiation through treatment completion, assessed for up to 24 months per treatment line.
4

Treatment-Related Mortality

The proportion of participants whose death is assessed as related to anticancer treatment.

Time frame
From initiation of first anticancer treatment to 30 days after the last administered treatment, assessed for up to 10 years across treatment lines.

Other outcomes

1

Plasma Epstein-Barr Virus (EBV) DNA Level

Plasma Epstein-Barr virus (EBV) DNA level (Copies/mL) will be quantitatively measured by real-time polymerase chain reaction (PCR) at predefined clinical time points in the prospective cohort.

Time frame
Baseline, after 2 treatment cycles, at end of treatment, and at relapse or refractory disease confirmation; assessed for up to 10 years.
2

Circulating Tumor DNA Mutation Detection Status

The presence or absence of tumor-derived somatic mutations detected in circulating tumor DNA will be evaluated by next-generation sequencing at predefined clinical time points.

Time frame
Baseline, after 2 treatment cycles, at end of treatment, and at relapse or refractory disease confirmation; assessed for up to 10 years.
3

Peripheral Blood Immune Cell Subset Frequencies

Frequencies of immune cell subsets in peripheral blood, including EBV-infected cell subsets when applicable, will be evaluated by flow cytometry at predefined clinical time points.

Time frame
Baseline, after 2 treatment cycles, at end of treatment, and at relapse or refractory disease confirmation; assessed for up to 10 years.
4

Peripheral Blood Cytokine Concentrations

Peripheral Blood Cytokine Concentrations

Time frame
Baseline, after 2 treatment cycles, at end of treatment or formal end-of-treatment assessment, and at relapse or refractory disease confirmation; assessed for up to 10 years.

Sponsors and contacts

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Rong Tao

Lead sponsor

Fudan University

Sponsor institution

Source ClinicalTrials.gov
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