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Prospective Observational International Registry of Patients With Newly Diagnosed Peripheral T Cell Lymphoma.

Recruitingn/aAges 18 Years - anyAllAssociazione Angela Serra per la ricerca sul canc…
NCT03964480 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 strateg

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

6 sites
Stanford University
Stanford, United States
IRCCS Istituto Tumori "Giovanni Paolo II"
Bari, Italy
Palermo_La Maddalena
Palermo, Italy
Terni-Santa Maria
Terni, Italy
Cluj Napoca_Ion Chiricuta Oncology Institute
Cluj-Napoca, Romania
National Cancer Institute
Kiev, Ukraine
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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