NCT Number: NCT07727083
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Shanghai, Shanghai Municipality, 200032, China
Location status: Recruiting
Chuanxu Liu, MD
CONTACT
008621-64175590 ext. 660103
Rong Tao, MD
CONTACT
008621-64175590 ext. 660103
Rong Tao, MD
PRINCIPAL_INVESTIGATOR
Epstein-Barr virus-positive T/NK-cell lymphoproliferative diseases comprise a heterogeneous spectrum of disorders that share viral and immunobiological features but differ substantially in clinical presentation, disease course, treatment, and prognosis. Extranodal NK/T-cell lymphoma is the principal disease entity in this study and will constitute the core population for clinical outcome analyses and development of integrated clinical-molecular prognostic models.
The study includes two cohorts. Cohort A is a retrospective cohort of approximately 500 consecutive hospitalized patients with newly diagnosed extranodal NK/T-cell lymphoma diagnosed between January 1, 2020 and December 31, 2025. Patients are identified through pathology records, followed by clinical verification and confirmation of survival follow-up. Cohort A includes clinical data only.
Cohort B is a prospective clinical-biological cohort of approximately 1,000 consecutive newly diagnosed patients enrolled between June 1, 2026 and December 31, 2030. Eligible disease entities include extranodal NK/T-cell lymphoma, aggressive NK-cell leukemia, systemic chronic active Epstein-Barr virus disease of T/NK-cell type, and Epstein-Barr virus-positive nodal T/NK-cell lymphoma. Extranodal NK/T-cell lymphoma will account for at least 80% of Cohort B.
Treatment is determined by treating physicians according to routine clinical practice and is not assigned by the study. Clinical information includes baseline disease characteristics, pathology, laboratory and imaging findings, treatment exposures, response assessments, adverse events, relapse or progression, subsequent treatment, and survival.
Prospective participants provide a 10-mL peripheral blood sample before treatment and are scheduled for additional sample collection after two treatment cycles, at the end of treatment or first formal end-of-treatment assessment, and at relapse or refractory disease confirmation. Plasma and peripheral blood mononuclear cells are stored in two aliquots at participating-center biobanks. Tumor tissue is optional. Molecular, viral, immune, and tumor microenvironment analyses will be performed within the scope approved by the protocol and informed consent.
The main clinical outcomes are overall survival and progression-free survival. Secondary outcomes include objective response rate, complete response rate, primary refractory disease, early progression, relapse or progression patterns, post-relapse survival, grade 3 or higher adverse events, serious infections, treatment-related mortality, and longitudinal changes in plasma Epstein-Barr virus DNA, circulating tumor DNA, and immune biomarkers.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From initial diagnosis to death or last confirmed follow-up, assessed for up to 10 years.
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 progression, relapse, death, or last disease assessment, assessed for up to 10 years.
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 initiation of first-line treatment through the first-line end-of-treatment assessment, assessed for up to 24 months.
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.
The proportion of response-evaluable participants who achieve complete response during first-line treatment.
Time frame: During each treatment line, from treatment initiation through treatment completion, assessed for up to 24 months per treatment line.
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: From initiation of first anticancer treatment to 30 days after the last administered treatment, assessed for up to 10 years across treatment lines.
The proportion of participants whose death is assessed as related to anticancer treatment.
Time frame: Baseline, after 2 treatment cycles, at end of treatment, and at relapse or refractory disease confirmation; assessed for up to 10 years.
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.
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.
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 or formal end-of-treatment assessment, and at relapse or refractory disease confirmation; assessed for up to 10 years.
Peripheral Blood Cytokine Concentrations
Contact information is provided by the study sponsor or research team.
Chuanxu Liu, MD
CONTACT
008621-64175590 ext. 660103
Rong Tao, MD
CONTACT
008621-64175590 ext. 660103
Rong Tao
Other
A Multicenter Ambidirectional Clinical and Biological Cohort Study of Epstein-Barr Virus-Positive T/NK-Cell Lymphoproliferative Diseases
Acronym: EBV-T/NK Cohor
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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