T-Cell Project: Prospective Collection of Data in Patients With Peripheral T-Cell Lymphoma
- 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
-
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
-
Age over 18
-
Tissue biopsies 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 5 years are requested
-
Written informed consent
-
Age < 18
-
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;
- Sรฉzary syndrome;
- Primary cutaneous ALCL
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival (OS) 5 years
- Secondary Outcome Measures
Name Time Method Event Free Survival (EFS) 5 years Remission rate with initial therapy End of front-line therapy Progression Free Survival (PFS) 5-years
Trial Locations
- Locations (75)
Tuen Mun Hospital
๐จ๐ณHong Kong, China
Presidio Ospedaliero Garibaldi-Nesima
๐ฎ๐นCatania, CT, Italy
Azienda O.U. Vittorio Emanuele-Ferrarotto-S. Bambino
๐ฎ๐นCatania, CT, Italy
Istituto Scientifico Universitario San Raffaele
๐ฎ๐นMilano, MI, Italy
Istituto Europeo di Oncologia
๐ฎ๐นMilano, MI, Italy
Ospedale Madonna delle Grazie
๐ฎ๐นMatera, Mount, Italy
Memorial Sloan-Kettering Cancer Center
๐บ๐ธNew York, New York, United States
Hospital Italiano
๐ฆ๐ทLa Plata, Buenos Aires, Argentina
Fred Hutchinson Cancer Research Center
๐บ๐ธSeattle, Washington, United States
Yale Cancer Center
๐บ๐ธNew Haven, Connecticut, United States
University of Nebraska Medical Center
๐บ๐ธOmaha, Nebraska, United States
MD Anderson Cancer Center
๐บ๐ธHouston, Texas, United States
Azienda Ospedaliera Pugliese-Ciaccio
๐ฎ๐นCatanzaro, Italy
Ospedale Centrale di Bolzano
๐ฎ๐นBolzano, Italy
Azienda Ospedaliera Universitaria Federico II
๐ฎ๐นNapoli, Italy
Ospedale Santo Spirito
๐ฎ๐นPescara, Italy
Nacional Cancer Institute
๐ธ๐ฐBratislava, Slovakia
Kantonsspital
๐จ๐ญAarau, AG, Switzerland
University of Southampton School of Medicine
๐ฌ๐งSouthampton, United Kingdom
Universitร La Sapienza
๐ฎ๐นRoma, Italy
Fundacion Fundaleu
๐ฆ๐ทBuenos Aires, Argentina
Santa Casa Medical School
๐ง๐ทSao Paulo, Brazil
Hospital del Salvador SSMO
๐จ๐ฑSantiago de Chile, Chile
Princess Margaret Hospital
๐จ๐ณHong Kong, China
Presidio Spedali Civili
๐ฎ๐นBrescia, BS, Italy
Azienda Ospedaliera Vito Fazzi
๐ฎ๐นLecce, LE, Italy
Azienda Ospedaliera Bianchi-Melacrino-Morelli
๐ฎ๐นReggio Calabria, RC, Italy
Presidio Ospedaliero Umberto I
๐ฎ๐นNocera Inferiore, SA, Italy
Azienda Ospedaliera S. Giovanni Battista
๐ฎ๐นTorino, TO, Italy
Istituto di Ematologia A & Seragnoli
๐ฎ๐นBologna, Italy
Ospedale Guglielmo da Saliceto
๐ฎ๐นPiacenza, Italy
Ospedale S. Giovanni
๐จ๐ญBellinzona, TI, Switzerland
Ospedale Civile
๐ฎ๐นCivitanova Marche, Macerata, Italy
Stanford University Medical Center
๐บ๐ธPalo Alto, California, United States
St Louis Washington University
๐บ๐ธSaint Louis, Missouri, United States
Cleveland Clinic Foundation
๐บ๐ธCleveland, Ohio, United States
Hospital San Martรฌn
๐ฆ๐ทLa Plata, Buenos Aires, Argentina
University of Campinas
๐ง๐ทCampinas, SP, Brazil
Sheba Medical Center
๐ฎ๐ฑTel-Aviv, Israel
Azienda Ospedaliera S. Croce e Carle
๐ฎ๐นCuneo, CN, Italy
Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte
๐ฎ๐นMessina, ME, Italy
Centro Oncologico Modenese
๐ฎ๐นModena, MO, Italy
Arcispedale S. Maria Nuova
๐ฎ๐นReggio Emilia, RE, Italy
Ospedale Oncologico A. Businco
๐ฎ๐นCagliari, Italy
Azienda Ospedaliera S. Maria
๐ฎ๐นTerni, Italy
Barths and The London NHS Trust
๐ฌ๐งLondon, United Kingdom
Queen Mary Hospital
๐จ๐ณHong Kong, China
Sourasky Medical Center
๐ฎ๐ฑTel-Aviv, Israel
Ospedale Casa Sollievo della Sofferenza IRCCS
๐ฎ๐นSan Giovanni Rotondo, FG, Italy
Istituto Clinico Humanitas
๐ฎ๐นMilano, MI, Italy
Azienda Ospedaliera Ospedale Niguarda Ca' Franda
๐ฎ๐นMilano, MI, Italy
Centro di Riferimento Oncologico
๐ฎ๐นAviano, Pordenone, Italy
Ospedale Felettino
๐ฎ๐นLa Spezia, Italy
Fondazione Policlinico MaRe IRCCS
๐ฎ๐นMilano, Italy
Azienda Ospedaliero-Universitaria
๐ฎ๐นParma, Italy
Ospedale Moscati
๐ฎ๐นTaranto, Italy
Ospedale Civile SS. Giovanni e Paolo
๐ฎ๐นVenezia, Italy
Hospital Universitario
๐ช๐ธSalamanca, Spain
Kantonsspital St. Gallen
๐จ๐ญSt. Gallen, Switzerland
University Hospital Birmingham NHS Foundation Trust
๐ฌ๐งBirmingham, United Kingdom
Samsung Medical Center
๐ฐ๐ทSeoul, Korea, Republic of
Casa di Cura La Maddalena
๐ฎ๐นPalermo, Pa, Italy
Hopital St Louis
๐ซ๐ทParis, France
Guy's and St. Thomas NHS Foundation Trust
๐ฌ๐งLondon, United Kingdom
Ospedale A. Perrino
๐ฎ๐นBrindisi, Italy
Istituto Oncologico Veneto
๐ฎ๐นPadova, PD, Italy
Azienda Ospedaliera Universitaria Careggi
๐ฎ๐นFirenze, Italy
Azienda Ospedaliera Maggiore della Caritร
๐ฎ๐นNovara, Italy
Azienda Ospedaliera Universitaria Pisana
๐ฎ๐นPisa, Italy
Ospedale S. Vincenzo
๐ฎ๐นTaormina, Italy
New Cross Hospital
๐ฌ๐งWolverhampton, United Kingdom
Hospital Maciel
๐บ๐พMontevideo, Uruguay
Hospital Clinic de Barcelona
๐ช๐ธBarcelona, Spain
Christie Hospital NHS Foundation Trust
๐ฌ๐งManchester, United Kingdom
Newcastle University
๐ฌ๐งNewcastle upon Tyne, United Kingdom