MedPath

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

Completed
Conditions
Lymphoma, T-Cell, Peripheral
Registration Number
NCT01142674
Lead Sponsor
Associazione Angela Serra per la ricerca sul cancro
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 Description

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-NOS, the FIL study confirms the relevance of research on series of clearly defined cases in order to the development of rationally designed and potentially more-efficacious treatment modalities. More recently, the role of biological features of the disease is emerging as an important issue not only for understanding its pathogenesis but also for prognosis and for addressing specific biologic targets altered in the neoplasia. Significant progress in the prognosis of PTCL can be expected from the novel, sophisticated, and powerful technologies of genomics and proteomics, which will allow more reliable subtyping of PTCL into distinct clinical groups characterized by different patterns of survival, as already demonstrated for some B-NHLs.

One common limitation of existing studies on prognosis of PTCL is their retrospective nature. Currently available data are based on analysis performed on series collected over a long period of time. This aspect is very important as it may introduce relevant biases in the collected series. First classification systems have changed dramatically over time and cases may have been defined in differently based on diagnosis year. Second some clinical or laboratory data which now are considered as prognostic relevant may have not been determined in older series of patients. Third in a retrospective analysis there is no guarantee that collected series are based on real consecutive cases. These are the reasons why we thought it would be useful to start a new study based on the prospective registration in a short period of time of patients with diagnosis of Peripheral T-cell lymphoma for whom it would be possible collect an exhaustive set of clinical data and biological information.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1650
Inclusion Criteria
  1. Previously-untreated patients with de novo diagnosis of peripheral T-cell or NK/T-cell lymphoma:

    • Peripheral T-cell lymphoma unspecified;
    • Peripheral T-cell lymphoma, lymphoepithelioid variant;
    • Peripheral T-cell lymphoma, T-zone variant ;
    • Peripheral T-cell lymphoma, parafollicular variant ;
    • Angioimmunoblastic T-cell lymphoma;
    • Nasal NK/T-cell lymphoma;
    • NK/T-cell lymphoma, nasal time;
    • Anaplastic large-cell lymphoma, T/null cell, ALK+, primary systemic type
    • Anaplastic large-cell lymphoma, T/null cell, ALK-, primary systemic type
    • Anaplastic large cell lymphoma, small cell variant, ALK+
    • Anaplastic large cell lymphoma, lymphohistiocytic variant, ALK+
    • Enteropathy- type T-cell lymphoma;
    • Hepatosplenic T-cell lymphoma;
    • Peripheral gamma-delta T-cell lymphoma;
    • Subcutaneous panniculitis-like T-cell lymphoma;
    • Unclassifiable peripheral T-cell Lymphoma
    • Unclassifiable NK-cell lymphoma
  2. Age over 18

  3. Tissue biopsies 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 5 years are requested

  5. Written informed consent

Exclusion Criteria
  1. Age < 18

  2. Diagnosis of T-cell or NK-cell leukemia or proliferation and other than mature types including:

    • Adult T-cell leukemia/lymphoma;
    • Blastic NK-cell leukemia/lymphoma;
    • Aggressive NK-cell leukemia
    • T-cell large granular lymphocytic leukemia
    • T-cell large granular lymphocytic proliferation
    • NK-cell large granular lymphocytic proliferation
    • T-cell prolymphocytic leukemia
    • Precursor T-cell lymphoblastic leukemia/lymphoma
    • Mycosis fungoides;
    • Sézary syndrome;
    • Primary cutaneous ALCL

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Overall Survival (OS)5 years
Secondary Outcome Measures
NameTimeMethod
Event Free Survival (EFS)5 years
Remission rate with initial therapyEnd of front-line therapy
Progression Free Survival (PFS)5-years

Trial Locations

Locations (75)

Stanford University Medical Center

🇺🇸

Palo Alto, California, United States

Yale Cancer Center

🇺🇸

New Haven, Connecticut, United States

St Louis Washington University

🇺🇸

Saint Louis, Missouri, United States

University of Nebraska Medical Center

🇺🇸

Omaha, Nebraska, United States

Memorial Sloan-Kettering Cancer Center

🇺🇸

New York, New York, United States

Cleveland Clinic Foundation

🇺🇸

Cleveland, Ohio, United States

MD Anderson Cancer Center

🇺🇸

Houston, Texas, United States

Fred Hutchinson Cancer Research Center

🇺🇸

Seattle, Washington, United States

Hospital Italiano

🇦🇷

La Plata, Buenos Aires, Argentina

Hospital San Martìn

🇦🇷

La Plata, Buenos Aires, Argentina

Scroll for more (65 remaining)
Stanford University Medical Center
🇺🇸Palo Alto, California, United States

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.