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

Lymphoma, T-Cell, Peripheral Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01142674
• Other study ID #: T-Cell Project
• Status: Completed
• Start date: September 2006
• Est. completion date: December 2018

Study information

• Verified date: July 2019
• Source: Associazione Angela Serra per la ricerca sul cancro
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1650
• Est. completion date: December 2018
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral

Locations

Country	Name	City	State
Argentina	Fundacion Fundaleu	Buenos Aires
Argentina	Hospital Italiano	La Plata	Buenos Aires
Argentina	Hospital San Martìn	La Plata	Buenos Aires
Brazil	University of Campinas	Campinas	SP
Brazil	Santa Casa Medical School	Sao Paulo
Chile	Hospital del Salvador SSMO	Santiago de Chile
China	Princess Margaret Hospital	Hong Kong
China	Queen Mary Hospital	Hong Kong
China	Tuen Mun Hospital	Hong Kong
France	Hopital St Louis	Paris
Israel	Sheba Medical Center	Tel-Aviv
Israel	Sourasky Medical Center	Tel-Aviv
Italy	Centro di Riferimento Oncologico	Aviano	Pordenone
Italy	Istituto di Ematologia A & Seragnoli	Bologna
Italy	Ospedale Centrale di Bolzano	Bolzano
Italy	Presidio Spedali Civili	Brescia	BS
Italy	Ospedale A. Perrino	Brindisi
Italy	Ospedale Oncologico A. Businco	Cagliari
Italy	Azienda O.U. Vittorio Emanuele-Ferrarotto-S. Bambino	Catania	CT
Italy	Presidio Ospedaliero Garibaldi-Nesima	Catania	CT
Italy	Azienda Ospedaliera Pugliese-Ciaccio	Catanzaro	CZ
Italy	Azienda Ospedaliera Pugliese-Ciaccio	Catanzaro
Italy	Ospedale Civile	Civitanova Marche	Macerata
Italy	Azienda Ospedaliera S. Croce e Carle	Cuneo	CN
Italy	Azienda Ospedaliera Universitaria Careggi	Firenze
Italy	Ospedale Felettino	La Spezia
Italy	Azienda Ospedaliera Vito Fazzi	Lecce	LE
Italy	Ospedale Madonna delle Grazie	Matera	Mount
Italy	Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte	Messina	ME
Italy	Azienda Ospedaliera Ospedale Niguarda Ca' Franda	Milano	MI
Italy	Fondazione Policlinico MaRe IRCCS	Milano
Italy	Istituto Clinico Humanitas	Milano	MI
Italy	Istituto Europeo di Oncologia	Milano	MI
Italy	Istituto Scientifico Universitario San Raffaele	Milano	MI
Italy	Centro Oncologico Modenese	Modena	MO
Italy	Azienda Ospedaliera Universitaria Federico II	Napoli
Italy	Presidio Ospedaliero Umberto I	Nocera Inferiore	SA
Italy	Azienda Ospedaliera Maggiore della Carità	Novara
Italy	Istituto Oncologico Veneto	Padova	PD
Italy	Casa di Cura La Maddalena	Palermo	Pa
Italy	Azienda Ospedaliero-Universitaria	Parma
Italy	Ospedale Santo Spirito	Pescara
Italy	Ospedale Guglielmo da Saliceto	Piacenza
Italy	Azienda Ospedaliera Universitaria Pisana	Pisa
Italy	Azienda Ospedaliera Bianchi-Melacrino-Morelli	Reggio Calabria	RC
Italy	Arcispedale S. Maria Nuova	Reggio Emilia	RE
Italy	Università La Sapienza	Roma
Italy	Ospedale Casa Sollievo della Sofferenza IRCCS	San Giovanni Rotondo	FG
Italy	Ospedale S. Vincenzo	Taormina
Italy	Ospedale Moscati	Taranto
Italy	Azienda Ospedaliera S. Maria	Terni
Italy	Azienda Ospedaliera S. Giovanni Battista	Torino	TO
Italy	Ospedale Civile SS. Giovanni e Paolo	Venezia
Korea, Republic of	Samsung Medical Center	Seoul
Slovakia	Nacional Cancer Institute	Bratislava
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Universitario	Salamanca
Switzerland	Kantonsspital	Aarau	AG
Switzerland	Ospedale S. Giovanni	Bellinzona	TI
Switzerland	Kantonsspital St. Gallen	St. Gallen
United Kingdom	University Hospital Birmingham NHS Foundation Trust	Birmingham
United Kingdom	Barths and The London NHS Trust	London
United Kingdom	Guy's and St. Thomas NHS Foundation Trust	London
United Kingdom	Christie Hospital NHS Foundation Trust	Manchester
United Kingdom	Newcastle University	Newcastle upon Tyne
United Kingdom	University of Southampton School of Medicine	Southampton
United Kingdom	New Cross Hospital	Wolverhampton
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	MD Anderson Cancer Center	Houston	Texas
United States	Yale Cancer Center	New Haven	Connecticut
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Stanford University Medical Center	Palo Alto	California
United States	St Louis Washington University	Saint Louis	Missouri
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
Uruguay	Hospital Maciel	Montevideo

Sponsors (3)

Lead Sponsor	Collaborator
Associazione Angela Serra per la ricerca sul cancro	Fondazione Italiana Linfomi ONLUS, INTERNATIONAL T-CELL NON-HODGKIN'S LYMPHOMA STUDY GROUP

Countries where clinical trial is conducted

United States,  Uruguay,  Argentina,  Brazil,  Chile,  China,  France,  Israel,  Italy,  Korea, Republic of,  Slovakia,  Spain,  Switzerland,  United Kingdom, 

References & Publications (20)

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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 lym — View Citation

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, 2

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-c — View Citation

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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 aggre

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 wi

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. — View Citation

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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(

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. — View Citation

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. — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)		5 years
Secondary	Event Free Survival (EFS)		5 years
Secondary	Remission rate with initial therapy		End of front-line therapy
Secondary	Progression Free Survival (PFS)		5-years