Clinical Trial: T-Cell Project: Prospective Collection of Data in Patients With Peripheral T-Cell Lymphoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Prospective Collection of Data in Pts With Peripheral T-Cell Lymphoma: PTCL,NOS;AITL; Extranodal NK/T-cell;Enteropathy-type; Hepatosplenic γ-δ; Subcutaneous Panniculiti

Brief Summary:

The designed study follows up the retrospective previous one by the International T-cell Non-Hodgkin's Lymphoma Study Group (International Peripheral T-Cell Lymphoma Project).

It is designed as a prospective collection of information potentially useful to predict the prognosis of newly diagnosed patients with the more frequent subtypes of Peripheral T-cell lymphoma (Peripheral T-cell lymphoma unspecified and Angioimmunoblastic T-cell lymphoma) and to better define clinical characteristics and outcome of the more uncommon subtypes


Detailed Summary:

Peripheral T-cell lymphomas (PTCLs) comprise a heterogeneous group of neoplasms that are derived from post-thymic lymphoid cells at different stages of differentiation with different morphological patterns, phenotypes, and clinical presentations. PTCLs are highly diverse, reflecting the diverse cells from which they can originate. Peripheral T-Cell Lymphomas account for 5-10% of all lymphoproliferative disorders in the Western hemisphere, with an overall incidence of 0.5-2 per 100,000 per year, and have a striking epidemiological distribution, with higher incidence in Asia.

The clinical features of PTCLs are extremely heterogeneous. PTCLs express even more clinical diversity than B-cell NHLs, and there is a close, though not absolute, relationship between some unusual clinical features and certain histological subtypes. Despite efforts to transferring to patients with T-cell lymphomas the most recent advances in the treatment of other subtypes of B-cell lymphomas, the prognosis of patients with PTCL is still poor an, unfortunately, the optimal therapy for PTCL is still unknown. The complete response rate is rather low, ranging from 40% to 50% with a median Relapse Free Survival (RFS) of 2-3 years. As a consequence of the aggressiveness of the disease and of the low efficacy of available salvage treatments, Overall Survival (OS) is also short and the long-term survival rate is lower than 10% in many series.

To better define the clinical outcome of PTCL-NOS, the Intergruppo Italiano Linfomi (IIL, now Fondazione Italiana Linfomi, FIL) performed a large study on 385 patients diagnosed and treated in the 1990s and defined a prognostic model specifically devised for patients with this uncommon disease (Gallamini, A. et al Blood, 2004. 103(7): p. 2474-9). In addition to defining a prognostic model specifically devised for PTCL-NO
Sponsor: Associazione Angela Serra per la ricerca sul cancro

Current Primary Outcome: Overall Survival (OS) [ Time Frame: 5 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Event Free Survival (EFS) [ Time Frame: 5 years ]
  • Remission rate with initial therapy [ Time Frame: End of front-line therapy ]
  • Progression Free Survival (PFS) [ Time Frame: 5-years ]


Original Secondary Outcome: Same as current

Information By: Associazione Angela Serra per la ricerca sul cancro

Dates:
Date Received: June 10, 2010
Date Started: September 2006
Date Completion: December 2022
Last Updated: August 8, 2016
Last Verified: August 2016