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

NCT ID: NCT01142674

Last Updated: 2019-07-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1650 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2018-12-31

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.

Conditions

Lymphoma, T-Cell, Peripheral

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Italiana Linfomi - ETS

OTHER

Sponsor Role: collaborator

INTERNATIONAL T-CELL NON-HODGKIN'S LYMPHOMA STUDY GROUP

UNKNOWN

Sponsor Role: collaborator

Associazione Angela Serra per la ricerca sul cancro

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Massimo Federico, MD

Role: STUDY_CHAIR

Dip. Medicina Diagnostica - Università di Modena e Reggio Emilia, , Modena, IT

Julie M. Vose, MD

Role: STUDY_CHAIR

Nebraska Medical Center, Omaha, NE, USA

Emanuele Zucca, MD

Role: STUDY_CHAIR

IOSI/Oncology Institute of Southern Switzerland, Ospedale S. Giovanni - Bellinzona, CH

Joseph M Connors, MD

Role: STUDY_CHAIR

British Columbia Cancer Agency, Vancouver, CA

Steven M. Horwitz, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Francine M. Foss, MD

Role: STUDY_CHAIR

Yale Cancer Center, New Haven, CT, USA

Pier Luigi Zinzani, MD

Role: STUDY_CHAIR

Istituto di Ematologia e Oncologia Medica "L. e A. Seragnoli", Policlinico Sant'Orsola, Bologna, IT

Silvia Montoto, MD

Role: STUDY_CHAIR

St. Bartholomew Hospital, London, UK

Aaron Polliack, MD

Role: STUDY_CHAIR

Sourasky Medical Center, Tel Aviv, IL

Stefano A. Pileri, MD

Role: STUDY_CHAIR

Università di Bologna, IT & Istituto Europeo di Oncologia, Milano, IT

Young H. Ko, MD

Role: STUDY_CHAIR

Samsung Medical Center, Seoul, KR

Locations

Stanford University Medical Center

Palo Alto, California, United States

Yale Cancer Center

New Haven, Connecticut, United States

St Louis Washington University

St 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

Fundacion Fundaleu

Buenos Aires, , Argentina

University of Campinas

Campinas, São Paulo, Brazil

Santa Casa Medical School

São Paulo, , Brazil

Hospital del Salvador SSMO

Santiago, , Chile

Princess Margaret Hospital

Hong Kong, , China

Queen Mary Hospital

Hong Kong, , China

Tuen Mun Hospital

Hong Kong, , China

Hopital St Louis

Paris, , France

Sheba Medical Center

Tel Aviv, , Israel

Sourasky Medical Center

Tel Aviv, , Israel

Presidio Spedali Civili

Brescia, BS, Italy

Azienda Ospedaliera S. Croce e Carle

Cuneo, CN, Italy

Presidio Ospedaliero Garibaldi-Nesima

Catania, CT, Italy

Azienda O.U. Vittorio Emanuele-Ferrarotto-S. Bambino

Catania, CT, Italy

Azienda Ospedaliera Pugliese-Ciaccio

Catanzaro, CZ, Italy

Ospedale Casa Sollievo della Sofferenza IRCCS

San Giovanni Rotondo, FG, Italy

Azienda Ospedaliera Vito Fazzi

Lecce, LE, Italy

Ospedale Civile

Civitanova Marche, Macerata, Italy

Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte

Messina, ME, Italy

Istituto Clinico Humanitas

Milan, MI, Italy

Istituto Scientifico Universitario San Raffaele

Milan, MI, Italy

Istituto Europeo di Oncologia

Milan, MI, Italy

Azienda Ospedaliera Ospedale Niguarda Ca' Franda

Milan, MI, Italy

Ospedale Madonna delle Grazie

Matera, Mount, Italy

Centro Oncologico Modenese

Modena, MO, Italy

Casa di Cura La Maddalena

Palermo, Pa, Italy

Istituto Oncologico Veneto

Padua, PD, Italy

Centro di Riferimento Oncologico

Aviano, Pordenone, Italy

Azienda Ospedaliera Bianchi-Melacrino-Morelli

Reggio Calabria, RC, Italy

Arcispedale S. Maria Nuova

Reggio Emilia, RE, Italy

Presidio Ospedaliero Umberto I

Nocera Inferiore, SA, Italy

Azienda Ospedaliera S. Giovanni Battista

Torino, TO, Italy

Istituto di Ematologia A & Seragnoli

Bologna, , Italy

Ospedale Centrale di Bolzano

Bolzano, , Italy

Ospedale A. Perrino

Brindisi, , Italy

Ospedale Oncologico A. Businco

Cagliari, , Italy

Azienda Ospedaliera Pugliese-Ciaccio

Catanzaro, , Italy

Azienda Ospedaliera Universitaria Careggi

Florence, , Italy

Ospedale Felettino

La Spezia, , Italy

Fondazione Policlinico MaRe IRCCS

Milan, , Italy

Azienda Ospedaliera Universitaria Federico II

Napoli, , Italy

Azienda Ospedaliera Maggiore della Carità

Novara, , Italy

Azienda Ospedaliero-Universitaria

Parma, , Italy

Ospedale Santo Spirito

Pescara, , Italy

Ospedale Guglielmo da Saliceto

Piacenza, , Italy

Azienda Ospedaliera Universitaria Pisana

Pisa, , Italy

Università La Sapienza

Roma, , Italy

Ospedale S. Vincenzo

Taormina, , Italy

Ospedale Moscati

Taranto, , Italy

Azienda Ospedaliera S. Maria

Terni, , Italy

Ospedale Civile SS. Giovanni e Paolo

Venezia, , Italy

Nacional Cancer Institute

Bratislava, , Slovakia

Samsung Medical Center

Seoul, , South Korea

Hospital Clinic de Barcelona

Barcelona, , Spain

Hospital Universitario

Salamanca, , Spain

Kantonsspital

Aarau, Canton of Aargau, Switzerland

Ospedale S. Giovanni

Bellinzona, Canton Ticino, Switzerland

Kantonsspital St. Gallen

Sankt Gallen, , Switzerland

University Hospital Birmingham NHS Foundation Trust

Birmingham, , United Kingdom

Barths and The London NHS Trust

London, , United Kingdom

Guy's and St. Thomas NHS Foundation Trust

London, , United Kingdom

Christie Hospital NHS Foundation Trust

Manchester, , United Kingdom

Newcastle University

Newcastle upon Tyne, , United Kingdom

University of Southampton School of Medicine

Southampton, , United Kingdom

New Cross Hospital

Wolverhampton, , United Kingdom

Hospital Maciel

Montevideo, , Uruguay

Countries

United States; Argentina; Brazil; Chile; China; France; Israel; Italy; Slovakia; South Korea; Spain; Switzerland; United Kingdom; Uruguay

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Related Links

http://www.tcellproject.org

Click here for more information about the T-Cell Project

Other Identifiers

T-Cell Project

Identifier Type: -

Identifier Source: org_study_id