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

  • STATUS
    Recruiting
  • End date
    Jul 30, 2025
  • participants needed
    1000
  • sponsor
    Associazione Angela Serra per la ricerca sul cancro
Updated on 25 January 2021
hodgkin's disease
lymphocytic leukemia
adult t-cell leukemia/lymphoma
panniculitis
t-cell lymphoma
peripheral t-cell lymphoma
angioimmunoblastic t-cell lymphoma
anaplastic large cell lymphoma
large cell lymphoma
hepatosplenic t-cell lymphoma
extranodal nk/t-cell lymphoma, nasal type
intestinal t-cell lymphoma
extranodal nk/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.

Description

Peripheral T-cell non-Hodgkin lymphomas (PTCLs) are a heterogeneous group of lymphoproliferative disorder arising from mature T cells of post-thymic origin at different stages of differentiation with different morphological patterns, phenotypes, and clinical presentation. All subtypes are found more commonly in male patients, and the median age at diagnosis is 62 years. This disease is generally associated with high relapse rates and a poor prognosis, with inferior treatment outcomes compared with B-cell lymphomas and have a 5-year-survival < 32%.

T-cell lymphomas are widely recognized as a complex and heterogeneous group of lymphoproliferative disorders, generally associated with high relapse rates and a poor prognosis. Because of their rarity, they are still very poorly understood.

The introduction of new and more effective therapies and better technologies led the International T-cell non-Hodgkin's Lymphoma Study Group to launch the T-cell Project 2.0 in order to have a contemporary, real-time understanding of the T-cell lymphoma biology and treatment, together with the application of contemporary technologies to further identification of new therapeutic targets.

Per protocol, patients are evaluated according to the treating physician's standard practice. There are no specific evaluations or visits required for the Registry. Data captured in the Registry reflects what is routinely collected for patients with PTCL.

The study plans to collect the tissue sample for central review. The ordinary fixation, cryopreservation and routine tumor cytogenetics are planned for biopsy samples. Chairmen of the Histopathology Review Panel will locate Regional sites where expert hematopathologists will review the material and perform a panel of immunostains (T-cell panel + CD20) and markers not assessed at local site.

Adding of blood sample collection will allow estimating prospectively the frequency of pEBVd detection in our cohort of PTCL patients at baseline and at the end of initial therapy, to characterize agreement between pEBVd and EBER in tumor tissue, and to explore the prognostic or predictive implications of detectable pEBVd in PTCL. Finally, to investigate the genetics and pathogenic mechanisms of aggressive PTCLs on an international scale.

Details
Condition Peripheral T-Cell Lymphoma, T-Cell Lymphoma
Clinical Study IdentifierNCT03964480
SponsorAssociazione Angela Serra per la ricerca sul cancro
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: T-Cell Lymphoma or Peripheral T-Cell Lymphoma?
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
Age 18 and over
Tissue biopsy adequate for diagnosis and classification and available for centralized review
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
Written informed consent

Exclusion Criteria

Diagnosis of
EBV-positive T-cell and NK-cell lymphoproliferative diseases of childhood
Mycosis fungoides
Szary 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
Age < 18\
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