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

Summary

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.

Eligibility

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.

Conditions2

Locations1 site

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