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

This study is currently recruiting participants.
Verified August 2016 by Associazione Angela Serra per la ricerca sul cancro
Sponsor:
ClinicalTrials.gov Identifier:
NCT01142674
First Posted: June 11, 2010
Last Update Posted: August 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Fondazione Italiana Linfomi ONLUS
International Peripheral T-Cell Lymphoma Project (Study group)
Information provided by (Responsible Party):
Associazione Angela Serra per la ricerca sul cancro
  Purpose

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


Condition
Lymphoma, T-Cell, Peripheral

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Associazione Angela Serra per la ricerca sul cancro:

Primary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA
Formalin-fixed tissue for central diagnostic pathology review

Estimated Enrollment: 2000
Study Start Date: September 2006
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Previously-untreated patients with de novo diagnosis of peripheral T-cell or NK/T-cell lymphoma
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01142674


Contacts
Contact: Monica Bellei, MSc, PhD +39 059 422 4020 monica.bellei@unimore.it
Contact: Emanuela A. Pesce, MSc,PhD +39 059 422 2577 emanuelaanna.pesce@unimore.it

  Show 76 Study Locations
Sponsors and Collaborators
Associazione Angela Serra per la ricerca sul cancro
Fondazione Italiana Linfomi ONLUS
International Peripheral T-Cell Lymphoma Project (Study group)
Investigators
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
  More Information

Additional Information:
Publications:
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.
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, Gabús 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.
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
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
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
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
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, Rüdiger 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. 2016 Jun 3. doi: 10.1002/hon.2316. [Epub ahead of print]
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.
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.
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. Review.
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.
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.
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.
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.
López-Guillermo A, Cid J, Salar A, López A, Montalbán C, Castrillo JM, González M, Ribera JM, Brunet S, García-Conde J, Fernández 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. Review.
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.
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. Epub 2003 Nov 26.
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.
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. Epub 2003 Sep 4.

Responsible Party: Associazione Angela Serra per la ricerca sul cancro
ClinicalTrials.gov Identifier: NCT01142674     History of Changes
Other Study ID Numbers: T-Cell Project
First Submitted: June 10, 2010
First Posted: June 11, 2010
Last Update Posted: August 9, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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

Keywords provided by Associazione Angela Serra per la ricerca sul cancro:
Lymphoma, T-Cell, Peripheral
Prognosis
Outcome
International Cooperation
Biological Characteristics
Heterogeneity
Rare Diseases

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin


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