Peripheral T-Cell Lymphoma Clinical Trial
Official title:
Prospective Observational International Registry of Patients With Newly Diagnosed Peripheral T Cell Lymphoma.
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.
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.
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