Clinical trial · Observational
Clinical and Biological Cohort Study of EBV-Positive T/NK-Cell Lymphoproliferative Diseases
A Multicenter Ambidirectional Clinical and Biological Cohort Study of Epstein-Barr Virus-Positive T/NK-Cell Lymphoproliferative Diseases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aggressive NK-Cell Leukemia | Aggressive NK-Cell Leukemia | ONTOLOGY_EXACT | 0.98 |
| Epstein-Barr Virus-Positive Nodal T/NK-Cell Lymphoma | — | UNRESOLVED | — |
| Epstein-Barr Virus-Positive T/NK-Cell Lymphoproliferative Disease | — | UNRESOLVED | — |
| Extranodal NK/T-cell Lymphoma | Nasal Type Extranodal NK/T-Cell Lymphoma | ALIAS | 0.90 |
| Systemic Chronic Active Epstein-Barr Virus Disease | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Retrospective NKTCL Cohort
- description
- Approximately 500 consecutive hospitalized patients with newly diagnosed extranodal NK/T-cell lymphoma diagnosed between January 1, 2017 and December 31, 2025. Clinical, treatment, response, relapse, safety, and survival information is collected from medical records and follow-up records. No biospecimen collection is mandated.
- label
- Prospective EBV-Positive T/NK Disease Cohort
- description
- Approximately 1,000 consecutive newly diagnosed patients enrolled between June 1, 2026 and December 31, 2030. Eligible diseases 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. Clinical information, longitudinal outcomes, and protocol-defined biospecimens are collected. Extranodal NK/T-cell lymphoma will represent at least 80% of this cohort.
Primary outcomes (2)
- measure
- Overall Survival
- timeFrame
- From initial diagnosis to death or last confirmed follow-up, assessed for up to 10 years.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. * For the prospective cohort: diagnosis between June 1, 2026 and December 31, 2030 of one of the following: * 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. * Availability of essential diagnostic, staging, and treatment information. * For the prospective cohort: written informed consent and successful collection of the protocol-required baseline peripheral blood specimen. Exclusion Criteria: * 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.
References
Publications (6)
- BACKGROUNDCheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo Espanol de Medula Osea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. doi: 10.1200/JCO.2013.54.8800. PMID 25113753
- RESULTLi D, Liu C, Wan J, Zhang W, Ma Y, Zhu Y, Ma L, Tian S, Ding H, Tao R. Sintilimab, pegaspargase, and anlotinib as induction therapy for advanced-stage NKTCL: a multicenter phase II study. Blood Adv. 2026 Mar 3:bloodadvances.2025018720. doi: 10.1182/bloodadvances.2025018720. Online ahead of print. PMID 41774854
- RESULTZhu Y, Tian S, Xu L, Ma Y, Zhang W, Wang L, Jin L, Liu C, Zhu C, Li Z, Hao S, Zhong H, Ding H, Tao R. GELAD chemotherapy with sandwiched radiotherapy for patients with newly diagnosed stage IE/IIE natural killer/T-cell lymphoma: a prospective multicentre study. Br J Haematol. 2022 Feb;196(4):939-946. doi: 10.1111/bjh.17960. Epub 2021 Nov 21. PMID 34806163
- RESULTLiu C, Ding H, Zhu Q, Liu P, Zhu Y, Wang L, Ma Y, Zhang W, Tian S, Zhang X, Jin L, Liu L, Li Z, Hao S, Tao R. Induction with MEDA regimen and consolidation with Auto-HSCT for stage IV NKTCL patients: A prospective multicenter study. Int J Cancer. 2022 Sep 1;151(5):752-763. doi: 10.1002/ijc.34055. Epub 2022 Jun 9. PMID 35489026
- RESULTOishi N, Ahmed R, Feldman AL. Updates in the Classification of T-cell Lymphomas and Lymphoproliferative Disorders. Curr Hematol Malig Rep. 2023 Dec;18(6):252-263. doi: 10.1007/s11899-023-00712-9. Epub 2023 Oct 23.