Lymphoma, T-Cell, PeripheralNCT01142674
T-Cell Project: Prospective Collection of Data in Patients With Peripheral T-Cell Lymphoma
An observational study of Lymphoma, T-Cell, Peripheral, run by Associazione Angela Serra per la ricerca sul cancro at 76 sites in 14 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, T-Cell, Peripheral
- How many people
- 1,650 participants
- Where
- 76 sitesin 14 countries
- Study dates
- Sep 2006to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Previously-untreated patients with de novo diagnosis of peripheral T-cell or NK/T-cell lymphoma
Who may be able to join
- 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;
Show all 22Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
76 sites in 14 countries.
76 sites in 14 countries
Italy41 sites
Centro di Riferimento Oncologico
Aviano, Pordenone, 33081
Istituto di Ematologia A & Seragnoli
Bologna, 40138
Ospedale Centrale di Bolzano
Bolzano, 39100
Presidio Spedali Civili
Brescia, BS, 25123
Ospedale A. Perrino
Brindisi, 72100
Ospedale Oncologico A. Businco
Cagliari, 09121
Presidio Ospedaliero Garibaldi-Nesima
Catania, CT, 95123
Azienda O.U. Vittorio Emanuele-Ferrarotto-S. Bambino
Catania, CT, 95124
Azienda Ospedaliera Pugliese-Ciaccio
Catanzaro, CZ, 88100
Azienda Ospedaliera Pugliese-Ciaccio
Catanzaro, 88100
Ospedale Civile
Civitanova Marche, Macerata, 62012
Azienda Ospedaliera S. Croce e Carle
Cuneo, CN, 12100
Azienda Ospedaliera Universitaria Careggi
Florence, 50134
Ospedale Felettino
La Spezia, 19100
Azienda Ospedaliera Vito Fazzi
Lecce, LE, 73100
Ospedale Madonna delle Grazie
Matera, Mount, 75100
Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte
Messina, ME, 98158
Istituto Clinico Humanitas
Milan, MI, 20089
Istituto Scientifico Universitario San Raffaele
Milan, MI, 20132
Istituto Europeo di Oncologia
Milan, MI, 20142
Azienda Ospedaliera Ospedale Niguarda Ca' Franda
Milan, MI
Fondazione Policlinico MaRe IRCCS
Milan, 20122
Centro Oncologico Modenese
Modena, MO, 41124
Azienda Ospedaliera Universitaria Federico II
Naples, 80130
Presidio Ospedaliero Umberto I
Nocera Inferiore, SA, 84014
Azienda Ospedaliera Maggiore della Carità
Novara, 28100
Istituto Oncologico Veneto
Padova, PD, 35128
Casa di Cura La Maddalena
Palermo, Pa, 90100
Azienda Ospedaliero-Universitaria
Parma
Ospedale Santo Spirito
Pescara, 65100
Ospedale Guglielmo da Saliceto
Piacenza, 29100
Azienda Ospedaliera Universitaria Pisana
Pisa, 56100
Azienda Ospedaliera Bianchi-Melacrino-Morelli
Reggio Calabria, RC, 89100
Arcispedale S. Maria Nuova
Reggio Emilia, RE, 42100
Università La Sapienza
Roma, 00161
Ospedale Casa Sollievo della Sofferenza IRCCS
San Giovanni Rotondo, FG, 71013
Ospedale S. Vincenzo
Taormina, 85123
Ospedale Moscati
Taranto, 74100
Azienda Ospedaliera S. Maria
Terni
Azienda Ospedaliera S. Giovanni Battista
Torino, TO, 10126
Ospedale Civile SS. Giovanni e Paolo
Venezia, 30123
United States8 sites
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
MD Anderson Cancer Center
Houston, Texas, 77030
Yale Cancer Center
New Haven, Connecticut, 06510
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
University of Nebraska Medical Center
Omaha, Nebraska, 68022
Stanford University Medical Center
Palo Alto, California, 94301
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98101
St Louis Washington University
St Louis, Missouri, 63130
United Kingdom7 sites
University Hospital Birmingham NHS Foundation Trust
Birmingham, B15 2TT
Barths and The London NHS Trust
London, EC1A 7BE
Guy's and St. Thomas NHS Foundation Trust
London, SE19RT
Christie Hospital NHS Foundation Trust
Manchester, M20 4BX
Newcastle University
Newcastle upon Tyne, NE17RU
University of Southampton School of Medicine
Southampton, SO16 6YD
New Cross Hospital
Wolverhampton, WV10 OQP
Argentina3 sites
Fundacion Fundaleu
Buenos Aires, C1114AAN
Hospital Italiano
La Plata, Buenos Aires, 1896
Hospital San Martìn
La Plata, Buenos Aires, 1900
China3 sites
Princess Margaret Hospital
Hong Kong
Queen Mary Hospital
Hong Kong
Tuen Mun Hospital
Hong Kong
Switzerland3 sites
Kantonsspital
Aarau, Canton of Aargau, 5001
Ospedale S. Giovanni
Bellinzona, Canton Ticino, 6500
Kantonsspital St. Gallen
Sankt Gallen, 9007
Brazil2 sites
University of Campinas
Campinas, São Paulo, 13083-97
Santa Casa Medical School
São Paulo, 01223
Israel2 sites
Sheba Medical Center
Tel Aviv, 52621
Sourasky Medical Center
Tel Aviv, 64239
Spain2 sites
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Universitario
Salamanca
About this study
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
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
Read the 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
- Keywords
- Lymphoma, T-Cell, Peripheral, Prognosis, Outcome, International Cooperation, Biological Characteristics, Heterogeneity, Rare Diseases
- Medical subject headings
- Lymphoma, T-Cell, Peripheral, Rare Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Measured: 5 years
Secondary outcomes (3)
Event Free Survival (EFS)
Measured: 5 years
Remission rate with initial therapy
Measured: End of front-line therapy
Progression Free Survival (PFS)
Measured: 5-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startSep 2006
- Primary completionJul 2016
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, T-Cell, PeripheralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associazione Angela Serra per la ricerca sul cancro
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Italiana Linfomi - ETS, INTERNATIONAL T-CELL NON-HODGKIN'S LYMPHOMA STUDY GROUP
- Responsible party
- Sponsor
- Investigators
- Massimo Federico, MD, Study chair, Dip. Medicina Diagnostica - Università di Modena e Reggio Emilia, , Modena, ITJulie M. Vose, MD, Study chair, Nebraska Medical Center, Omaha, NE, USAEmanuele Zucca, MD, Study chair, IOSI/Oncology Institute of Southern Switzerland, Ospedale S. Giovanni - Bellinzona, CHJoseph M Connors, MD, Study chair, British Columbia Cancer Agency, Vancouver, CASteven M. Horwitz, MD, Study chair, Memorial Sloan Kettering Cancer CenterFrancine M. Foss, MD, Study chair, Yale Cancer Center, New Haven, CT, USAPier Luigi Zinzani, MD, Study chair, Istituto di Ematologia e Oncologia Medica "L. e A. Seragnoli", Policlinico Sant'Orsola, Bologna, ITSilvia Montoto, MD, Study chair, St. Bartholomew Hospital, London, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142674
- Sponsor's protocol ID
- T-Cell Project
- Status last verified
- Jul 2019
- First submitted
- 10 Jun 2010
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Preliminary analysis results will be made available during the study on the single population and separately for each subtype. Final results will be made available 6-12 months after the end of the study
Publications
Harris NL, Jaffe ES, Diebold J, Flandrin G, Muller-Hermelink HK, Vardiman J, Lister TA, Bloomfield CD. World Health Organization classification of neoplastic diseases of the hematopoietic and lymphoid tissues: report of the Clinical Advisory Committee meeting-Airlie House, Virginia, November 1997. J Clin Oncol. 1999 Dec;17(12):3835-49. doi: 10.1200/JCO.1999.17.12.3835.
PubMed 10577857Jones D, O'Hara C, Kraus MD, Perez-Atayde AR, Shahsafaei A, Wu L, Dorfman DM. Expression pattern of T-cell-associated chemokine receptors and their chemokines correlates with specific subtypes of T-cell non-Hodgkin lymphoma. Blood. 2000 Jul 15;96(2):685-90.
PubMed 10887135Picker LJ, Weiss LM, Medeiros LJ, Wood GS, Warnke RA. Immunophenotypic criteria for the diagnosis of non-Hodgkin's lymphoma. Am J Pathol. 1987 Jul;128(1):181-201.
PubMed 3111266Cooke CB, Krenacs L, Stetler-Stevenson M, Greiner TC, Raffeld M, Kingma DW, Abruzzo L, Frantz C, Kaviani M, Jaffe ES. Hepatosplenic T-cell lymphoma: a distinct clinicopathologic entity of cytotoxic gamma delta T-cell origin. Blood. 1996 Dec 1;88(11):4265-74.
PubMed 8943863Melnyk A, Rodriguez A, Pugh WC, Cabannillas F. Evaluation of the Revised European-American Lymphoma classification confirms the clinical relevance of immunophenotype in 560 cases of aggressive non-Hodgkin's lymphoma. Blood. 1997 Jun 15;89(12):4514-20.
PubMed 9192775Armitage JO, Weisenburger DD. New approach to classifying non-Hodgkin's lymphomas: clinical features of the major histologic subtypes. Non-Hodgkin's Lymphoma Classification Project. J Clin Oncol. 1998 Aug;16(8):2780-95. doi: 10.1200/JCO.1998.16.8.2780.
PubMed 9704731Ascani S, Zinzani PL, Gherlinzoni F, Sabattini E, Briskomatis A, de Vivo A, Piccioli M, Fraternali Orcioni G, Pieri F, Goldoni A, Piccaluga PP, Zallocco D, Burnelli R, Leoncini L, Falini B, Tura S, Pileri SA. Peripheral T-cell lymphomas. Clinico-pathologic study of 168 cases diagnosed according to the R.E.A.L. Classification. Ann Oncol. 1997 Jun;8(6):583-92. doi: 10.1023/a:1008200307625.
PubMed 9261528Lopez-Guillermo A, Cid J, Salar A, Lopez A, Montalban C, Castrillo JM, Gonzalez M, Ribera JM, Brunet S, Garcia-Conde J, Fernandez de Sevilla A, Bosch F, Montserrat E. Peripheral T-cell lymphomas: initial features, natural history, and prognostic factors in a series of 174 patients diagnosed according to the R.E.A.L. Classification. Ann Oncol. 1998 Aug;9(8):849-55. doi: 10.1023/a:1008418727472.
PubMed 9789607Savage KJ, Chhanabhai M, Gascoyne RD, Connors JM. Characterization of peripheral T-cell lymphomas in a single North American institution by the WHO classification. Ann Oncol. 2004 Oct;15(10):1467-75. doi: 10.1093/annonc/mdh392.
PubMed 15367405Gallamini A, Stelitano C, Calvi R, Bellei M, Mattei D, Vitolo U, Morabito F, Martelli M, Brusamolino E, Iannitto E, Zaja F, Cortelazzo S, Rigacci L, Devizzi L, Todeschini G, Santini G, Brugiatelli M, Federico M; Intergruppo Italiano Linfomi. Peripheral T-cell lymphoma unspecified (PTCL-U): a new prognostic model from a retrospective multicentric clinical study. Blood. 2004 Apr 1;103(7):2474-9. doi: 10.1182/blood-2003-09-3080. Epub 2003 Nov 26.
PubMed 14645001Zaja F, Russo D, Silvestri F, Fanin R, Damiani D, Infanti L, Salmaso F, Mariuzzi L, Di Loreto C, Baccarani M. Retrospective analysis of 23 cases with peripheral T-cell lymphoma, unspecified: clinical characteristics and outcome. Haematologica. 1997 Mar-Apr;82(2):171-7.
PubMed 9175321Tsuchiya T, Ohshima K, Karube K, Yamaguchi T, Suefuji H, Hamasaki M, Kawasaki C, Suzumiya J, Tomonaga M, Kikuchi M. Th1, Th2, and activated T-cell marker and clinical prognosis in peripheral T-cell lymphoma, unspecified: comparison with AILD, ALCL, lymphoblastic lymphoma, and ATLL. Blood. 2004 Jan 1;103(1):236-41. doi: 10.1182/blood-2002-05-1352. Epub 2003 Sep 4.
PubMed 12958063Federico M, Bellei M, Pesce, E, Zucca E, Pileri S, Montoto S, Weisenburger DD, Ruediger T, KO YH, Liang R, Zinzani PL, Connors JM, Foss FM, Horwitz SM, Polliack A, Vose JM. T-Cell Project: an international, longitudinal, observational study of patients with aggressive peripheral T-cell lymphoma. Revista Brasileira de Hematologia e Hemoterapia 31(suppl 2):21-25,2009.
Federico M, Bellei M, Pesce EA, Zucca E, Pielri S, Montoto S, Weisenburger D, Rugiger T, Ko Y, Liang R, Zinzani PL, Connors J, Foss F, Horwitz S, Polliack A, Vose J. T-Cell Project: an international, prospective, observational study of patients with aggressive Peripheral T-cell Lymphoma. Analysis of the first 524 patients. 11 ICML, Lugano (Switzerland), 15-18 June 2011. Abs 241. Ann Oncol 22 (suppl 4), 2011
Bellei M, Chiattone CS, Luminari S, Pesce EA, Cabrera ME, de Souza CA, Gabus R, Zoppegno L, Zoppegno L, Milone J, Pavlovsky A, Connors JM, Foss FM, Horwitz SM, Liang R, Montoto S, Pileri SA, Polliack A, Vose JM, Zinzani PL, Zucca E, Federico M. T-cell lymphomas in South america and europe. Rev Bras Hematol Hemoter. 2012;34(1):42-7. doi: 10.5581/1516-8484.20120013.
PubMed 23049383
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01142674
- Acronym / sponsor ID
- T-Cell Project
- Conditions
- Lymphoma, T-Cell, Peripheral
- Keywords
- Lymphoma, T-Cell, Peripheral, Prognosis, Outcome, International Cooperation, Biological Characteristics, Heterogeneity, Rare Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,650 participants (estimated)
- Lead sponsor
- Associazione Angela Serra per la ricerca sul cancroUniversity, hospital or other
- Collaborators
- Fondazione Italiana Linfomi - ETS, INTERNATIONAL T-CELL NON-HODGKIN'S LYMPHOMA STUDY GROUP
- Study start
- Sep 2006 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 11 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Previously-untreated patients with de novo diagnosis of peripheral T-cell or NK/T-cell lymphoma
Key inclusion criteria (22 listed)
- Previously-untreated patients with de novo diagnosis of peripheral T-cell or NK/T-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
Key exclusion criteria (13 listed)
- Age < 18
- Diagnosis of T-cell or NK-cell leukemia or proliferation and other than mature types including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival (OS)
Time frame: 5 years
3 secondary outcomes
Event Free Survival (EFS)
Time frame: 5 years
Remission rate with initial therapy
Time frame: End of front-line therapy
Progression Free Survival (PFS)
Time frame: 5-years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Background: PubMed 10577857Harris NL, Jaffe ES, Diebold J, Flandrin G, Muller-Hermelink HK, Vardiman J, Lister TA, Bloomfield CD. World Health Organization classification of neoplastic diseases of the hematopoietic and lymphoid tissues: report of the Clinical Advisory Committee meeting-Airlie House, Virginia, November 1997. J Clin Oncol. 1999 Dec;17(12):3835-49. doi: 10.1200/JCO.1999.17.12.3835.
- Background: PubMed 10887135Jones D, O'Hara C, Kraus MD, Perez-Atayde AR, Shahsafaei A, Wu L, Dorfman DM. Expression pattern of T-cell-associated chemokine receptors and their chemokines correlates with specific subtypes of T-cell non-Hodgkin lymphoma. Blood. 2000 Jul 15;96(2):685-90.
- Background: PubMed 3111266Picker LJ, Weiss LM, Medeiros LJ, Wood GS, Warnke RA. Immunophenotypic criteria for the diagnosis of non-Hodgkin's lymphoma. Am J Pathol. 1987 Jul;128(1):181-201.
- Background: PubMed 8943863Cooke CB, Krenacs L, Stetler-Stevenson M, Greiner TC, Raffeld M, Kingma DW, Abruzzo L, Frantz C, Kaviani M, Jaffe ES. Hepatosplenic T-cell lymphoma: a distinct clinicopathologic entity of cytotoxic gamma delta T-cell origin. Blood. 1996 Dec 1;88(11):4265-74.
- Background: PubMed 9192775Melnyk A, Rodriguez A, Pugh WC, Cabannillas F. Evaluation of the Revised European-American Lymphoma classification confirms the clinical relevance of immunophenotype in 560 cases of aggressive non-Hodgkin's lymphoma. Blood. 1997 Jun 15;89(12):4514-20.
- Background: PubMed 9704731Armitage JO, Weisenburger DD. New approach to classifying non-Hodgkin's lymphomas: clinical features of the major histologic subtypes. Non-Hodgkin's Lymphoma Classification Project. J Clin Oncol. 1998 Aug;16(8):2780-95. doi: 10.1200/JCO.1998.16.8.2780.
- Background: PubMed 9261528Ascani S, Zinzani PL, Gherlinzoni F, Sabattini E, Briskomatis A, de Vivo A, Piccioli M, Fraternali Orcioni G, Pieri F, Goldoni A, Piccaluga PP, Zallocco D, Burnelli R, Leoncini L, Falini B, Tura S, Pileri SA. Peripheral T-cell lymphomas. Clinico-pathologic study of 168 cases diagnosed according to the R.E.A.L. Classification. Ann Oncol. 1997 Jun;8(6):583-92. doi: 10.1023/a:1008200307625.
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- Click here for more information about the T-Cell ProjectLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Preliminary analysis results will be made available during the study on the single population and separately for each subtype. Final results will be made available 6-12 months after the end of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massimo Federico, MD study chair
Dip. Medicina Diagnostica - Università di Modena e Reggio Emilia, , Modena, IT
Julie M. Vose, MD study chair
Nebraska Medical Center, Omaha, NE, USA
Emanuele Zucca, MD study chair
IOSI/Oncology Institute of Southern Switzerland, Ospedale S. Giovanni - Bellinzona, CH
76 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, T-Cell, Peripheral, run by Associazione Angela Serra per la ricerca sul cancro at 76 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 76 sites in Italy, United States, United Kingdom, Argentina, China and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01142674, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2019.