Clinical trial NCT01142674: T-Cell Project: Prospective Collection of Data in Patients With Peripheral T-Cell Lymphoma
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 Panniculitis-like; ALCL,Primary Systemic Type. By the Intl. T-Cell Lymphoma Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma, T-Cell, Peripheral
Keywords: Lymphoma, T-Cell, Peripheral
Prognosis
Outcome
International Cooperation
Biological Characteristics
Heterogeneity
Rare Diseases
Lead sponsor: Associazione Angela Serra per la ricerca sul cancro
Sponsor class: OTHER
Collaborators: name: Fondazione Italiana Linfomi - ETS
name: INTERNATIONAL T-CELL NON-HODGKIN'S LYMPHOMA STUDY GROUP
First posted: 2010-06-11
Enrollment: 1650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Previously-untreated patients with de novo diagnosis of peripheral T-cell or NK/T-cell lymphoma

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.

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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: 5 years
Secondary outcomes:
measure: Event Free Survival (EFS)
timeFrame: 5 years
measure: Remission rate with initial therapy
timeFrame: End of front-line therapy
measure: Progression Free Survival (PFS)
timeFrame: 5-years
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Saint Louis
country: United States
facility: St Louis Washington University
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: La Plata
country: Argentina
facility: Hospital Italiano
state: Buenos Aires
city: La Plata
country: Argentina
facility: Hospital San Martìn
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Fundacion Fundaleu
city: Campinas
country: Brazil
facility: University of Campinas
state: SP
city: Sao Paulo
country: Brazil
facility: Santa Casa Medical School
city: Santiago de Chile
country: Chile
facility: Hospital del Salvador SSMO
city: Hong Kong
country: China
facility: Princess Margaret Hospital
city: Hong Kong
country: China
facility: Queen Mary Hospital
city: Hong Kong
country: China
facility: Tuen Mun Hospital
city: Paris
country: France
facility: Hopital St Louis
city: Tel-Aviv
country: Israel
facility: Sheba Medical Center
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Center
city: Brescia
country: Italy
facility: Presidio Spedali Civili
state: BS
city: Cuneo
country: Italy
facility: Azienda Ospedaliera S. Croce e Carle
state: CN
city: Catania
country: Italy
facility: Presidio Ospedaliero Garibaldi-Nesima
state: CT
city: Catania
country: Italy
facility: Azienda O.U. Vittorio Emanuele-Ferrarotto-S. Bambino
state: CT
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Pugliese-Ciaccio
state: CZ
city: San Giovanni Rotondo
country: Italy
facility: Ospedale Casa Sollievo della Sofferenza IRCCS
state: FG
city: Lecce
country: Italy
facility: Azienda Ospedaliera Vito Fazzi
state: LE
city: Civitanova Marche
country: Italy
facility: Ospedale Civile
state: Macerata
city: Messina
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte
state: ME
city: Milano
country: Italy
facility: Istituto Clinico Humanitas
state: MI
city: Milano
country: Italy
facility: Istituto Scientifico Universitario San Raffaele
state: MI
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
state: MI
city: Milano
country: Italy
facility: Azienda Ospedaliera Ospedale Niguarda Ca' Franda
state: MI
city: Matera
country: Italy
facility: Ospedale Madonna delle Grazie
state: Mount
city: Modena
country: Italy
facility: Centro Oncologico Modenese
state: MO
city: Palermo
country: Italy
facility: Casa di Cura La Maddalena
state: Pa
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
state: PD
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico
state: Pordenone
city: Reggio Calabria
country: Italy
facility: Azienda Ospedaliera Bianchi-Melacrino-Morelli
state: RC
city: Reggio Emilia
country: Italy
facility: Arcispedale S. Maria Nuova
state: RE
city: Nocera Inferiore
country: Italy
facility: Presidio Ospedaliero Umberto I
state: SA
city: Torino
country: Italy
facility: Azienda Ospedaliera S. Giovanni Battista
state: TO
city: Bologna
country: Italy
facility: Istituto di Ematologia A & Seragnoli
city: Bolzano
country: Italy
facility: Ospedale Centrale di Bolzano
city: Brindisi
country: Italy
facility: Ospedale A. Perrino
city: Cagliari
country: Italy
facility: Ospedale Oncologico A. Businco
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Pugliese-Ciaccio
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: La Spezia
country: Italy
facility: Ospedale Felettino
city: Milano
country: Italy
facility: Fondazione Policlinico MaRe IRCCS
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Novara
country: Italy
facility: Azienda Ospedaliera Maggiore della Carità
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria
city: Pescara
country: Italy
facility: Ospedale Santo Spirito
city: Piacenza
country: Italy
facility: Ospedale Guglielmo da Saliceto
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana
city: Roma
country: Italy
facility: Università La Sapienza
city: Taormina
country: Italy
facility: Ospedale S. Vincenzo
city: Taranto
country: Italy
facility: Ospedale Moscati
city: Terni
country: Italy
facility: Azienda Ospedaliera S. Maria
city: Venezia
country: Italy
facility: Ospedale Civile SS. Giovanni e Paolo
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Bratislava
country: Slovakia
facility: Nacional Cancer Institute
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Salamanca
country: Spain
facility: Hospital Universitario
city: Aarau
country: Switzerland
facility: Kantonsspital
state: AG
city: Bellinzona
country: Switzerland
facility: Ospedale S. Giovanni
state: TI
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Birmingham
country: United Kingdom
facility: University Hospital Birmingham NHS Foundation Trust
city: London
country: United Kingdom
facility: Barths and The London NHS Trust
city: London
country: United Kingdom
facility: Guy's and St. Thomas NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Foundation Trust
city: Newcastle upon Tyne
country: United Kingdom
facility: Newcastle University
city: Southampton
country: United Kingdom
facility: University of Southampton School of Medicine
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
city: Montevideo
country: Uruguay
facility: Hospital Maciel
Study officials:
affiliation: Dip. Medicina Diagnostica - Università di Modena e Reggio Emilia, , Modena, IT
name: Massimo Federico, MD
role: STUDY_CHAIR
affiliation: Nebraska Medical Center, Omaha, NE, USA
name: Julie M. Vose, MD
role: STUDY_CHAIR
affiliation: IOSI/Oncology Institute of Southern Switzerland, Ospedale S. Giovanni - Bellinzona, CH
name: Emanuele Zucca, MD
role: STUDY_CHAIR
affiliation: British Columbia Cancer Agency, Vancouver, CA
name: Joseph M Connors, MD
role: STUDY_CHAIR
affiliation: Memorial Sloan Kettering Cancer Center
name: Steven M. Horwitz, MD
role: STUDY_CHAIR
affiliation: Yale Cancer Center, New Haven, CT, USA
name: Francine M. Foss, MD
role: STUDY_CHAIR
affiliation: Istituto di Ematologia e Oncologia Medica "L. e A. Seragnoli", Policlinico Sant'Orsola, Bologna, IT
name: Pier Luigi Zinzani, MD
role: STUDY_CHAIR
affiliation: St. Bartholomew Hospital, London, UK
name: Silvia Montoto, MD
role: STUDY_CHAIR
affiliation: Sourasky Medical Center, Tel Aviv, IL
name: Aaron Polliack, MD
role: STUDY_CHAIR
affiliation: Università di Bologna, IT & Istituto Europeo di Oncologia, Milano, IT
name: Stefano A. Pileri, MD
role: STUDY_CHAIR
affiliation: Samsung Medical Center, Seoul, KR
name: Young H. Ko, MD
role: STUDY_CHAIR
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