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

NCT01142674 | Completed

• 1 other identifier: T-Cell Project
• Study Type: observational
• Target: 1,650
• Locations: 14 countries
• Sites: 76

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

Conditions

Lymphoma, T-Cell, Peripheral

Keywords

Lymphoma, T-Cell, Peripheral; Prognosis; Outcome; International Cooperation; Biological Characteristics; Heterogeneity; Rare Diseases

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  5 years

Secondary Outcomes (3)

• Event Free Survival (EFS)

  5 years

• Remission rate with initial therapy

  End of front-line therapy

• Progression Free Survival (PFS)

  5-years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Previously-untreated patients with de novo diagnosis of peripheral T-cell or NK/T-cell lymphoma

You may qualify if:

• 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;

You may not qualify if:

• 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;
• Sézary syndrome;
• Primary cutaneous ALCL

Sponsors & Collaborators

• Associazione Angela Serra per la ricerca sul cancro: lead
• Fondazione Italiana Linfomi - ETS: collaborator
• INTERNATIONAL T-CELL NON-HODGKIN'S LYMPHOMA STUDY GROUP: collaborator

Study Sites (76)

Stanford University Medical Center

Palo Alto, California, 94301, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06510, United States

Location

St Louis Washington University

St Louis, Missouri, 63130, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68022, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98101, United States

Location

Hospital Italiano

La Plata, Buenos Aires, 1896, Argentina

Location

Hospital San Martìn

La Plata, Buenos Aires, 1900, Argentina

Location

Fundacion Fundaleu

Buenos Aires, C1114AAN, Argentina

Location

University of Campinas

Campinas, São Paulo, 13083-97, Brazil

Location

Santa Casa Medical School

São Paulo, 01223, Brazil

Location

Hospital del Salvador SSMO

Santiago, 3580000, Chile

Location

Princess Margaret Hospital

Hong Kong, China

Location

Queen Mary Hospital

Hong Kong, China

Location

Tuen Mun Hospital

Hong Kong, China

Location

Hopital St Louis

Paris, France

Location

Sheba Medical Center

Tel Aviv, 52621, Israel

Location

Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Presidio Spedali Civili

Brescia, BS, 25123, Italy

Location

Azienda Ospedaliera S. Croce e Carle

Cuneo, CN, 12100, Italy

Location

Presidio Ospedaliero Garibaldi-Nesima

Catania, CT, 95123, Italy

Location

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

Catania, CT, 95124, Italy

Location

Azienda Ospedaliera Pugliese-Ciaccio

Catanzaro, CZ, 88100, Italy

Location

Ospedale Casa Sollievo della Sofferenza IRCCS

San Giovanni Rotondo, FG, 71013, Italy

Location

Azienda Ospedaliera Vito Fazzi

Lecce, LE, 73100, Italy

Location

Ospedale Civile

Civitanova Marche, Macerata, 62012, Italy

Location

Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte

Messina, ME, 98158, Italy

Location

Istituto Clinico Humanitas

Milan, MI, 20089, Italy

Location

Istituto Scientifico Universitario San Raffaele

Milan, MI, 20132, Italy

Location

Istituto Europeo di Oncologia

Milan, MI, 20142, Italy

Location

Azienda Ospedaliera Ospedale Niguarda Ca' Franda

Milan, MI, Italy

Location

Ospedale Madonna delle Grazie

Matera, Mount, 75100, Italy

Location

Centro Oncologico Modenese

Modena, MO, 41124, Italy

Location

Casa di Cura La Maddalena

Palermo, Pa, 90100, Italy

Location

Istituto Oncologico Veneto

Padua, PD, 35128, Italy

Location

Centro di Riferimento Oncologico

Aviano, Pordenone, 33081, Italy

Location

Azienda Ospedaliera Bianchi-Melacrino-Morelli

Reggio Calabria, RC, 89100, Italy

Location

Arcispedale S. Maria Nuova

Reggio Emilia, RE, 42100, Italy

Location

Presidio Ospedaliero Umberto I

Nocera Inferiore, SA, 84014, Italy

Location

Azienda Ospedaliera S. Giovanni Battista

Torino, TO, 10126, Italy

Location

Istituto di Ematologia A & Seragnoli

Bologna, 40138, Italy

Location

Ospedale Centrale di Bolzano

Bolzano, 39100, Italy

Location

Ospedale A. Perrino

Brindisi, 72100, Italy

Location

Ospedale Oncologico A. Businco

Cagliari, 09121, Italy

Location

Azienda Ospedaliera Pugliese-Ciaccio

Catanzaro, 88100, Italy

Location

Azienda Ospedaliera Universitaria Careggi

Florence, 50134, Italy

Location

Ospedale Felettino

La Spezia, 19100, Italy

Location

Fondazione Policlinico MaRe IRCCS

Milan, 20122, Italy

Location

Azienda Ospedaliera Universitaria Federico II

Napoli, 80130, Italy

Location

Azienda Ospedaliera Maggiore della Carità

Novara, 28100, Italy

Location

Azienda Ospedaliero-Universitaria

Parma, Italy

Location

Ospedale Santo Spirito

Pescara, 65100, Italy

Location

Ospedale Guglielmo da Saliceto

Piacenza, 29100, Italy

Location

Azienda Ospedaliera Universitaria Pisana

Pisa, 56100, Italy

Location

Università La Sapienza

Roma, 00161, Italy

Location

Ospedale S. Vincenzo

Taormina, 85123, Italy

Location

Ospedale Moscati

Taranto, 74100, Italy

Location

Azienda Ospedaliera S. Maria

Terni, Italy

Location

Ospedale Civile SS. Giovanni e Paolo

Venezia, 30123, Italy

Location

Nacional Cancer Institute

Bratislava, 40138, Slovakia

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario

Salamanca, Spain

Location

Kantonsspital

Aarau, Canton of Aargau, 5001, Switzerland

Location

Ospedale S. Giovanni

Bellinzona, Canton Ticino, 6500, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

University Hospital Birmingham NHS Foundation Trust

Birmingham, B15 2TT, United Kingdom

Location

Barths and The London NHS Trust

London, EC1A 7BE, United Kingdom

Location

Guy's and St. Thomas NHS Foundation Trust

London, SE19RT, United Kingdom

Location

Christie Hospital NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Newcastle University

Newcastle upon Tyne, NE17RU, United Kingdom

Location

University of Southampton School of Medicine

Southampton, SO16 6YD, United Kingdom

Location

New Cross Hospital

Wolverhampton, WV10 OQP, United Kingdom

Location

Hospital Maciel

Montevideo, 11000, Uruguay

Location

Related Publications (25)

• 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.

  PMID: 10577857 BACKGROUND

• Jones 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.

  PMID: 10887135 BACKGROUND

• Picker 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.

  PMID: 3111266 BACKGROUND

• Cooke 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.

  PMID: 8943863 BACKGROUND

• Melnyk 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.

  PMID: 9192775 BACKGROUND

• Armitage 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.

  PMID: 9704731 BACKGROUND

• Ascani 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.

  PMID: 9261528 BACKGROUND

• Lopez-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.

  PMID: 9789607 BACKGROUND

• Savage 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.

  PMID: 15367405 BACKGROUND

• Gallamini 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.

  PMID: 14645001 BACKGROUND

• Zaja 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.

  PMID: 9175321 BACKGROUND

• Tsuchiya 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.

  PMID: 12958063 BACKGROUND

• Federico 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.

  RESULT

• 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

  RESULT

• 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.

  PMID: 23049383 RESULT

• Federico M, Bellei M, Luminari S, Horwitz SM, Montoto S, Zucca E, Pileri SA, Ko YH, Zinzani PL, Connors JM, Foss FM, Polliack A, Cabrera ME, Kim WS, Spina M, De Souza CA, Bobillo Varela S, Dlouhy I, Advani RH, Vose J and T-Cell Project. CD30+ expression in Peripheral T-cell lymphomas (PTCLs): A subset analysis from the international, prospective T-Cell Project. Journal of Clinical Oncology, 2015 ASCO Annual Meeting (May 29 - June 2, 2015).Vol 33, No 15_suppl (May 20 Supplement), 2015: 8552

  RESULT

• Federico M, Bellei M, Pesce EA, et al. T-Cell Project: an international, prospective, observational study of patients with aggressive Peripheral NK/T-Cell Lymphoma: Lesson from the first 1308 patients. 13 ICML, Lugano (Switzerland) 17-20 June, 2015. Abstract 070. Hematol Oncol 2015; 33(Suppl1):100-180

  RESULT

• Bellei M, Marcheselli L, Pesce EA, et al. Clinical Characteristics and Patterns of Care of Patients (pts) with Peripheral T-cell Lymphoma (PTCLs) according to age at time of diagnosis: A T-Cell Project snapshot. 13 ICML, Lugano (Switzerland) 17-20 June, 2015. Abstract 231. Hematol Oncol 2015; 33(Suppl1):181-243

  RESULT

• Horwitz SM, Bellei M, Marcheselli L, et al. The role of transplant in the treatment of Peripheral T-cell Lymphomas (PTCLs): an analysis from the T-cell Project database. 13 ICML, Lugano (Switzerland) 17-20 June, 2015. Abstract 247. Hematol Oncol 2015; 33(Suppl1):181-243

  RESULT

• Bellei M, Sabattini E, Pesce EA, Ko YH, Kim WS, Cabrera ME, Martinez V, Dlouhy I, Paes RP, Barrese T, Vassallo J, Tarantino V, Vose J, Weisenburger D, Rudiger T, Federico M, Pileri S. Pitfalls and major issues in the histologic diagnosis of peripheral T-cell lymphomas: results of the central review of 573 cases from the T-Cell Project, an international, cooperative study. Hematol Oncol. 2017 Dec;35(4):630-636. doi: 10.1002/hon.2316. Epub 2016 Jun 3.

  PMID: 27255982 RESULT

• Chiattone C, Civallero M, Fischer T, Miranda E, Manni M, Zing NPC, Pileri SA, Montoto S, Horwitz SM, Cabrera ME, De Souza CA, Nagler A, Luminari S, Ferreri AJM, Carson KR, Re A, Rigacci L, Nassi L, Stepanishyna Y, Federico M, Inghirami G. Characteristics and clinical outcomes of patients with ALK-positive anaplastic large cell lymphoma: Report from the prospective international T-cell lymphoma project. Hematol Oncol. 2022 Dec;40(5):953-961. doi: 10.1002/hon.3074. Epub 2022 Sep 15.

  PMID: 36083035 DERIVED

• Advani RH, Skrypets T, Civallero M, Spinner MA, Manni M, Kim WS, Shustov AR, Horwitz SM, Hitz F, Cabrera ME, Dlouhy I, Vassallo J, Pileri SA, Inghirami G, Montoto S, Vitolo U, Radford J, Vose JM, Federico M. Outcomes and prognostic factors in angioimmunoblastic T-cell lymphoma: final report from the international T-cell Project. Blood. 2021 Jul 22;138(3):213-220. doi: 10.1182/blood.2020010387.

  PMID: 34292324 DERIVED

• Shustov A, Cabrera ME, Civallero M, Bellei M, Ko YH, Manni M, Skrypets T, Horwitz SM, De Souza CA, Radford JA, Bobillo S, Prates MV, Ferreri AJM, Chiattone C, Spina M, Vose JM, Chiappella A, Laszlo D, Marino D, Stelitano C, Federico M. ALK-negative anaplastic large cell lymphoma: features and outcomes of 235 patients from the International T-Cell Project. Blood Adv. 2021 Feb 9;5(3):640-648. doi: 10.1182/bloodadvances.2020001581.

  PMID: 33560375 DERIVED

• Fox CP, Civallero M, Ko YH, Manni M, Skrypets T, Pileri S, Kim SJ, Cabrera ME, Shustov AR, Chiattone CS, Horwitz SM, Dlouhy I, Spina M, Hitz F, Montoto S, Nagler A, Martinez V, De Souza CA, Fernandez-Alvarez R, Ballova V, Gabus R, Inghirami G, Federico M, Kim WS. Survival outcomes of patients with extranodal natural-killer T-cell lymphoma: a prospective cohort study from the international T-cell Project. Lancet Haematol. 2020 Apr;7(4):e284-e294. doi: 10.1016/S2352-3026(19)30283-2. Epub 2020 Feb 24.

  PMID: 32105608 DERIVED

• Bellei M, Foss FM, Shustov AR, Horwitz SM, Marcheselli L, Kim WS, Cabrera ME, Dlouhy I, Nagler A, Advani RH, Pesce EA, Ko YH, Martinez V, Montoto S, Chiattone C, Moskowitz A, Spina M, Biasoli I, Manni M, Federico M; International T-cell Project Network. The outcome of peripheral T-cell lymphoma patients failing first-line therapy: a report from the prospective, International T-Cell Project. Haematologica. 2018 Jul;103(7):1191-1197. doi: 10.3324/haematol.2017.186577. Epub 2018 Mar 29.

  PMID: 29599200 DERIVED

Related Links

• Click here for more information about the T-Cell Project

Biospecimen

Retention: SAMPLES WITHOUT DNA

Formalin-fixed tissue for central diagnostic pathology review

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral; Rare Diseases

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2010
• First Posted: June 11, 2010
• Study Start: September 1, 2006
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2018
• Last Updated: July 8, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share

Locations

IT (41); IL (2); CN (3); FR (1); GB (7); CL (1); BR (2); UR (1); AR (3); SL (1); KR (1); ES (2); CH (3); US (8)