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

T-Cell Project: Prospective Collection of Data in Patients With
Peripheral T-Cell Lymphoma
Status: Recruiting
Study Phase: N/A
Start Date: September 2006 | Completion Date: December 2022
Condition(s): Lymphoma, T-Cell, Peripheral
Full Title of Study
Prospective Collection of Data in Pts With Peripheral T-Cell Lymphoma:
PTCL,NOS;AITL; Extranodal NK/T-cell;Enteropathy-type; Hepatosplenic γ-δ;
Subcutaneous Panniculitis-like; ALCL,Primary Systemic Type. By the Intl. T-Cell
Lymphoma Project
Overview
The designed study follows up the retrospective previous one by the International Tcell 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.
Study Details
Study Type: Observational
Study Design: Observational Model: Cohort, Time Perspective: Prospective
Investigator Details
Lead Sponsor: Associazione Angela Serra per la ricerca sul cancro
Collaborator: Fondazione Italiana Linfomi ONLUS
Collaborator: International Peripheral T-Cell Lymphoma Project (Study group)
Study Chair: Massimo Federico, MD Dip. Medicina Diagnostica - Università di Modena e Reggio Emilia, , Modena,
IT
Study Chair: Julie M. Vose, MD Nebraska Medical Center, Omaha, NE, USA
Study Chair: Emanuele Zucca, MD IOSI/Oncology Institute of Southern Switzerland, Ospedale S. Giovanni Bellinzona, CH
Study Chair: Joseph M Connors, MD British Columbia Cancer Agency, Vancouver, CA
Study Chair: Steven M. Horwitz, MD Memorial Sloan Kettering Cancer Center
Study Chair: Francine M. Foss, MD Yale Cancer Center, New Haven, CT, USA
Study Chair: Pier Luigi Zinzani, MD Istituto di Ematologia e Oncologia Medica "L. e A. Seragnoli", Policlinico
Sant'Orsola, Bologna, IT
Study Chair: Silvia Montoto, MD St. Bartholomew Hospital, London, UK
Study Chair: Aaron Polliack, MD Sourasky Medical Center, Tel Aviv, IL
Study Chair: Stefano A. Pileri, MD Università di Bologna, IT & Istituto Europeo di Oncologia, Milano, IT
Study Chair: Young H. Ko, MD Samsung Medical Center, Seoul, KR
Trial Location Details
Facility: Stanford University Medical Center Palo Alto, United States
Principal Investigator: Rajana Advani, MD
Facility: Yale Cancer Center New Haven, United States
Facility: St Louis Washington University St Louis, United States
Principal Investigator: Kenneth Carson, MD
Facility: University of Nebraska Medical Center Omaha, United States
Principal Investigator: Julie M Vose, MD
Facility: Memorial Sloan-Kettering Cancer Center New York, United States
Principal Investigator: Steven Horwitz, MD
Facility: Cleveland Clinic Foundation Cleveland, United States
Facility: MD Anderson Cancer Center Houston, United States
Principal Investigator: Barbara Pro, MD
Facility: Fred Hutchinson Cancer Research Center Seattle, United States
Principal Investigator: Andrei Shustov, MD
Facility: Hospital Italiano La Plata, Argentina
Principal Investigator: Jorge Milone, MD
Facility: Hospital San Martìn La Plata, Argentina
Principal Investigator: Lucia Zoppegno, MD
Facility: Fundacion Fundaleu Buenos Aires, Argentina
Principal Investigator: Astrid Pavlovsky, MD
Facility: University of Campinas Campinas, Brazil
Principal Investigator: Carmino de Souza, MD
Facility: Santa Casa Medical School Sao Paulo, Brazil
Principal Investigator: Carlos Chiattone, MD, PhD
Facility: Hospital del Salvador SSMO Santiago de Chile, Chile
Principal Investigator: Maria E. Cabrera, MD
Facility: Princess Margaret Hospital Hong Kong, China
Facility: Queen Mary Hospital Hong Kong, China
Facility: Tuen Mun Hospital Hong Kong, China
Facility: Hopital St Louis Paris, France
Principal Investigator: Catherine Thieblemont, MD
Facility: Sheba Medical Center Tel-Aviv, Israel
Principal Investigator: Arnon Nagler, MD
Facility: Sourasky Medical Center Tel-Aviv, Israel
Facility: Presidio Spedali Civili Brescia, Italy
Principal Investigator: Giuseppe Rossi, PD
Facility: Azienda Ospedaliera S. Croce e Carle Cuneo, Italy
Facility: Presidio Ospedaliero Garibaldi-Nesima Catania, Italy
Principal Investigator: Patrizia Guglielmo, MD
Facility: Azienda O.U. Vittorio Emanuele-Ferrarotto-S. Bambino Catania, Italy
Principal Investigator: Francesco Di Raimondo, MD
Facility: Azienda Ospedaliera Pugliese-Ciaccio Catanzaro, Italy
Principal Investigator: Renato Cantaffa, MD
Facility: Ospedale Casa Sollievo della Sofferenza IRCCS S. Giovanni Rotondo, Italy
Principal Investigator: Nicola Cascavilla, MD
Facility: Azienda Ospedaliera Vito Fazzi Lecce, Italy
Principal Investigator: Nicola Di Renzo, MD
Facility: Ospedale Civile Civitanova Marche, Italy
Principal Investigator: Riccardo Centurioni, MD
Facility: Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte Messina, Italy
Principal Investigator: Maura Brugiatelli, MD
Facility: Istituto Clinico Humanitas Milano, Italy
Principal Investigator: Armando Santoro, MD
Facility: Istituto Scientifico Universitario San Raffaele Milano, Italy
Principal Investigator: Andres Ferreri, MD
Facility: Istituto Europeo di Oncologia Milano, Italy
Principal Investigator: Giovanni Martinelli, MD
Facility: Azienda Ospedaliera Ospedale Niguarda Ca' Franda Milano, Italy
Principal Investigator: Enrica Morra, MD
Facility: Centro Oncologico Modenese Modena, Italy
Principal Investigator: Massimo Federico, MD
Facility: Ospedale Madonna delle Grazie Matera, Italy
Principal Investigator: Alberto Fragasso, MD
Facility: Casa di Cura La Maddalena Palermo, Italy
Principal Investigator: Maurizio Musso, MD
Facility: Istituto Oncologico Veneto Padova, Italy
Principal Investigator: Savina Aversa, MD
Facility: Centro di Riferimento Oncologico Aviano, Italy
Principal Investigator: Michele Spina, MD
Facility: Azienda Ospedaliera Bianchi-Melacrino-Morelli Reggio Calabria, Italy
Principal Investigator: Francesco Nobile, MD
Facility: Arcispedale S. Maria Nuova Reggio Emilia, Italy
Principal Investigator: Francesco Merli, MD
Facility: Presidio Ospedaliero Umberto I Nocera Inferiore, Italy
Principal Investigator: Alfonso M. D'Arco, MD
Facility: Azienda Ospedaliera S. Giovanni Battista Torino, Italy
Principal Investigator: Umberto Vitolo, MD
Facility: Istituto di Ematologia A & Seragnoli Bologna, Italy
Principal Investigator: Michele Baccarani, MD
Facility: Ospedale Centrale di Bolzano Bolzano, Italy
Principal Investigator: Sergio Cortelazzo, MD
Facility: Ospedale A. Perrino Brindisi, Italy
Principal Investigator: Giovanni Quarta, MD
Facility: Ospedale Oncologico A. Businco Cagliari, Italy
Principal Investigator: Maria G Cabras, MD
Facility: Azienda Ospedaliera Pugliese-Ciaccio Catanzaro, Italy
Principal Investigator: Stefano Molica, MD
Facility: Azienda Ospedaliera Universitaria Careggi Firenze, Italy
Principal Investigator: Luigi Rigacci, MD
Facility: Ospedale Felettino La Spezia, Italy
Principal Investigator: Annunziata Manna, MD
Facility: Fondazione Policlinico MaRe IRCCS Milano, Italy
Principal Investigator: Luca Baldini, MD
Facility: Azienda Ospedaliera Universitaria Federico II Napoli, Italy
Principal Investigator: Fabrizio Pane, MD
Facility: Azienda Ospedaliera Maggiore della Carità Novara, Italy
Principal Investigator: Gianluca Gaidano, MD
Facility: Azienda Ospedaliero-Universitaria Parma, Italy
Principal Investigator: Francesca Re, MD
Facility: Ospedale Santo Spirito Pescara, Italy
Principal Investigator: Francesco Angrilli, MD
Facility: Ospedale Guglielmo da Saliceto Piacenza, Italy
Principal Investigator: Daniele Vallisa, MD
Facility: Azienda Ospedaliera Universitaria Pisana Pisa, Italy
Principal Investigator: Francesco Caracciolo, MD
Facility: Università La Sapienza Roma, Italy
Principal Investigator: Maurizio Martelli, MD
Facility: Ospedale S. Vincenzo Taormina, Italy
Principal Investigator: Giuseppe Mineo, MD
Facility: Ospedale Moscati Taranto, Italy
Principal Investigator: Patrizio Mazza, MD
Facility: Azienda Ospedaliera S. Maria Terni, Italy
Principal Investigator: Anna Marina Liberati, MD
Facility: Ospedale Civile SS. Giovanni e Paolo Venezia, Italy
Principal Investigator: Teodoro Chisesi, MD
Facility: Samsung Medical Center Seoul, Korea, Republic of
Principal Investigator: Won S Kim, MD PhD
Facility: Nacional Cancer Institute Bratislava, Slovakia
Principal Investigator: Veronika Ballova, MD
Facility: Hospital Clinic de Barcelona Barcelona, Spain
Principal Investigator: Armando Lopez Guillermo, MD
Facility: Hospital Universitario Salamanca, Spain
Principal Investigator: Dolores Caballero, MD
Facility: Kantonsspital Aarau, Switzerland
Facility: Ospedale S. Giovanni Bellinzona, Switzerland
Principal Investigator: Emanuele Zucca, PD
Facility: Kantonsspital St. Gallen St. Gallen, Switzerland
Principal Investigator: Felicitas Hitz, MD
Facility: University Hospital Birmingham NHS Foundation Trust Birmingham, United Kingdom
Principal Investigator: Martin Rowe, MD
Facility: Barths and The London NHS Trust London, United Kingdom
Principal Investigator: Silvia Montoto, MD
Facility: Guy's and St. Thomas NHS Foundation Trust London, United Kingdom
Facility: Christie Hospital NHS Foundation Trust Manchester, United Kingdom
Principal Investigator: John Radford, MD
Facility: Newcastle University Newcastle upon Tyne, United Kingdom
Facility: University of Southampton School of Medicine Southampton, United Kingdom
Principal Investigator: Peter Johnson, MD
Facility: New Cross Hospital Wolverhampton, United Kingdom
Facility: Hospital Maciel Montevideo, Uruguay
Principal Investigator: Raul Gabus, MD
Published Research
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Ascani S, Zinzani PL, Gherlinzoni F, Sabattini E, Briskomatis A, de Vivo A, Piccioli M, Fraternali Orcioni G, Pieri F, Goldoni A, Piccaluga
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Gallamini A, Stelitano C, Calvi R, Bellei M, Mattei D, Vitolo U, Morabito F, Martelli M, Brusamolino E, Iannitto E, Zaja F, Cortelazzo S,
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Information Source
ID Number: T-Cell Project
NCT Identifier: NCT01142674
Health Authority: Italy: The Italian Medicines Agency
Full Source of Clinical Trial Data: https://clinicaltrials.gov/show/NCT01142674
ClinicalTrials.gov processed this data on September 29, 2016
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately
by this site. Please see the full source link above for retrieving further details from the government database.