Clinical trial · Observational
Prospective Observational International Registry of Patients With Newly Diagnosed Peripheral T Cell Lymphoma.
- 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 study T-Cell Project 2.0 is based on the former International PTCL study designed by the International T-cell Non-Hodgkin's Lymphoma Study Group (T-Cell Project 1.0: Prospective Collection of Data in Patients With Peripheral T-Cell Lymphoma) as a prospective collection of data to predict the prognosis of patients with the more frequent subtypes of PTCL. It is a prospective, longitudinal, international, observational study of patients with newly diagnosed peripheral T-cell lymphoma aiming to verify whether this prospective collection of data would allow achieving a more accurate information on T-cell lymphomas. The study aims to better define the clinical relevance of the new WHO Classification, the role of FDG-PET in staging and response assessment, the prognosis of different entities, the genomic landscape of different subtypes, and to investigate on most optimal treatment strategies for these neoplasms in the real-world population as well as molecular markers and to explore the prognostic or predictive implications of them in PTCL. The study aims to better define the clinical relevance of the new WHO Classification, the role of FDG-PET in staging and response assessment, the prognosis of different entities, the genomic landscape of different subtypes, and to investigate on most optimal treatment strategies for these neoplasms in the real-world population.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral T-Cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression-free survival (PFS)
- timeFrame
- 2 year
- description
- Measured from the date of diagnosis until the date of disease progression or death from T-cell Lymphoma
Secondary outcomes (4)
- measure
- Overall Survival (OS)
- timeFrame
- 3 and 5 year
- description
- Measured from the date of diagnosis until death from any cause
- measure
- Progression-Free Survival (PFS)
- timeFrame
- 3 and 5 years
- description
- Measured from the date of diagnosis until the date of disease progression or death from T-cell Lymphoma
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Previously-untreated patients with de novo diagnosis of peripheral T-cell or NK/T-cell lymphoma: * T-cell large granular lymphocytic leukaemia; * Chronic lymphoproliferative disorder of NK cells; * Aggressive NK-cell leukaemia; * Adult T-cell leukaemia/lymphoma; * Extranodal NK/T-cell lymphoma, nasal type; * Intestinal T-cell lymphoma; * Hepatosplenic T-cell lymphoma; * Subcutaneous panniculitis-like T-cell lymphoma; * Peripheral T-cell lymphoma, not otherwise specified; * Angioimmunoblastic T-cell lymphoma and other nodal lymphomas of T follicular helper cell origin; * Anaplastic large cell lymphoma, ALK-positive; * Anaplastic large cell lymphoma, ALK-negative; * Breast implant-associated anaplastic large cell lymphoma. 2. Age 18 and over; 3. Tissue biopsy adequate for diagnosis and classification and available for centralized review; 4. Clinical data including baseline information on disease localization and laboratory parameters at staging, features of treatment adopted and assurance of follow-up updating for at least 2 years are requested; 5. Written informed consent. Exclusion Criteria: 1. Diagnosis of: * EBV-positive T-cell and NK-cell lymphoproliferative diseases of childhood * Mycosis fungoides; * Sézary syndrome; * Primary cutaneous CD30-positive T-cell lymphoproliferative disorders; * Primary cutaneous peripheral T-cell lymphomas, rare subtypes; * T-cell lymphoblastic lymphoma/leukemia * T-cell prolymphocitic leukemia 2. Age \< 18.
References
Publications (46)
- BACKGROUNDAnsell S. How to select the frontline treatment for a patient with peripheral T-cell lymphoma. Leuk Lymphoma. 2016;57(4):783-8. doi: 10.3109/10428194.2016.1140760. Epub 2016 Feb 5. PMID 26850659
- BACKGROUNDVose J, Armitage J, Weisenburger D; International T-Cell Lymphoma Project. International peripheral T-cell and natural killer/T-cell lymphoma study: pathology findings and clinical outcomes. J Clin Oncol. 2008 Sep 1;26(25):4124-30. doi: 10.1200/JCO.2008.16.4558. Epub 2008 Jul 14. PMID 18626005
- BACKGROUNDA clinical evaluation of the International Lymphoma Study Group classification of non-Hodgkin's lymphoma. The Non-Hodgkin's Lymphoma Classification Project. Blood. 1997 Jun 1;89(11):3909-18. PMID 9166827
- BACKGROUNDSavage KJ. Peripheral T-cell lymphomas. Blood Rev. 2007 Jul;21(4):201-16. doi: 10.1016/j.blre.2007.03.001. Epub 2007 May 18. PMID 17512649
- BACKGROUNDIqbal J, Wright G, Wang C, Rosenwald A, Gascoyne RD, Weisenburger DD, Greiner TC, Smith L, Guo S, Wilcox RA, Teh BT, Lim ST, Tan SY, Rimsza LM, Jaffe ES, Campo E, Martinez A, Delabie J, Braziel RM, Cook JR, Tubbs RR, Ott G, Geissinger E, Gaulard P, Piccaluga PP, Pileri SA, Au WY, Nakamura S, Seto M, Berger F, de Leval L, Connors JM, Armitage J, Vose J, Chan WC, Staudt LM; Lymphoma Leukemia Molecular Profiling Project and the International Peripheral T-cell Lymphoma Project. Gene expression signatures delineate biological and prognostic subgroups in peripheral T-cell lymphoma. Blood. 2014 May 8;123(19):2915-23. doi: 10.1182/blood-2013-11-536359. Epub 2014 Mar 14. PMID 24632715
- BACKGROUNDBarbui T, Thiele J, Gisslinger H, Kvasnicka HM, Vannucchi AM, Guglielmelli P, Orazi A, Tefferi A. The 2016 WHO classification and diagnostic criteria for myeloproliferative neoplasms: document summary and in-depth discussion. Blood Cancer J. 2018 Feb 9;8(2):15. doi: 10.1038/s41408-018-0054-y. PMID 29426921