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

• Sponsor: Associazione Angela Serra per la ricerca sul cancro (Other)
• Overall Status: Completed
• CT.gov ID: NCT01142674
• Collaborator: Fondazione Italiana Linfomi ONLUS (Other), INTERNATIONAL T-CELL NON-HODGKIN'S LYMPHOMA STUDY GROUP (Other)
• Enrollment: 1,650
• Locations: 76
• Actual Duration (Months): 147
• Patients Per Site: 21.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, T-Cell, Peripheral

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

• Study Type: Observational
• Anticipated Enrollment: 1650 participants
• 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
• Actual Study Start Date: Sep 1, 2006
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Dec 1, 2018

Outcome Measures

Primary Outcome Measures

1. Overall Survival (OS) [5 years]

Secondary Outcome Measures

1. Event Free Survival (EFS) [5 years]

2. Remission rate with initial therapy [End of front-line therapy]

3. Progression Free Survival (PFS) [5-years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. Age over 18

2. Tissue biopsies adequate for diagnosis and classification and available for centralized review

3. 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

4. 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

Locations

	Site	City	State	Country	Postal Code
1	Stanford University Medical Center	Palo Alto	California	United States	94301
2	Yale Cancer Center	New Haven	Connecticut	United States	06510
3	St Louis Washington University	Saint Louis	Missouri	United States	63130
4	University of Nebraska Medical Center	Omaha	Nebraska	United States	68022
5	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
6	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
7	MD Anderson Cancer Center	Houston	Texas	United States	77030
8	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98101
9	Hospital Italiano	La Plata	Buenos Aires	Argentina	1896
10	Hospital San Martìn	La Plata	Buenos Aires	Argentina	1900
11	Fundacion Fundaleu	Buenos Aires		Argentina	C1114AAN
12	University of Campinas	Campinas	SP	Brazil	13083-97
13	Santa Casa Medical School	Sao Paulo		Brazil	01223
14	Hospital del Salvador SSMO	Santiago de Chile		Chile	3580000
15	Princess Margaret Hospital	Hong Kong		China
16	Queen Mary Hospital	Hong Kong		China
17	Tuen Mun Hospital	Hong Kong		China
18	Hopital St Louis	Paris		France
19	Sheba Medical Center	Tel-Aviv		Israel	52621
20	Sourasky Medical Center	Tel-Aviv		Israel	64239
21	Presidio Spedali Civili	Brescia	BS	Italy	25123
22	Azienda Ospedaliera S. Croce e Carle	Cuneo	CN	Italy	12100
23	Presidio Ospedaliero Garibaldi-Nesima	Catania	CT	Italy	95123
24	Azienda O.U. Vittorio Emanuele-Ferrarotto-S. Bambino	Catania	CT	Italy	95124
25	Azienda Ospedaliera Pugliese-Ciaccio	Catanzaro	CZ	Italy	88100
26	Ospedale Casa Sollievo della Sofferenza IRCCS	San Giovanni Rotondo	FG	Italy	71013
27	Azienda Ospedaliera Vito Fazzi	Lecce	LE	Italy	73100
28	Ospedale Civile	Civitanova Marche	Macerata	Italy	62012
29	Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte	Messina	ME	Italy	98158
30	Istituto Clinico Humanitas	Milano	MI	Italy	20089
31	Istituto Scientifico Universitario San Raffaele	Milano	MI	Italy	20132
32	Istituto Europeo di Oncologia	Milano	MI	Italy	20142
33	Azienda Ospedaliera Ospedale Niguarda Ca' Franda	Milano	MI	Italy
34	Ospedale Madonna delle Grazie	Matera	Mount	Italy	75100
35	Centro Oncologico Modenese	Modena	MO	Italy	41124
36	Casa di Cura La Maddalena	Palermo	Pa	Italy	90100
37	Istituto Oncologico Veneto	Padova	PD	Italy	35128
38	Centro di Riferimento Oncologico	Aviano	Pordenone	Italy	33081
39	Azienda Ospedaliera Bianchi-Melacrino-Morelli	Reggio Calabria	RC	Italy	89100
40	Arcispedale S. Maria Nuova	Reggio Emilia	RE	Italy	42100
41	Presidio Ospedaliero Umberto I	Nocera Inferiore	SA	Italy	84014
42	Azienda Ospedaliera S. Giovanni Battista	Torino	TO	Italy	10126
43	Istituto di Ematologia A & Seragnoli	Bologna		Italy	40138
44	Ospedale Centrale di Bolzano	Bolzano		Italy	39100
45	Ospedale A. Perrino	Brindisi		Italy	72100
46	Ospedale Oncologico A. Businco	Cagliari		Italy	09121
47	Azienda Ospedaliera Pugliese-Ciaccio	Catanzaro		Italy	88100
48	Azienda Ospedaliera Universitaria Careggi	Firenze		Italy	50134
49	Ospedale Felettino	La Spezia		Italy	19100
50	Fondazione Policlinico MaRe IRCCS	Milano		Italy	20122
51	Azienda Ospedaliera Universitaria Federico II	Napoli		Italy	80130
52	Azienda Ospedaliera Maggiore della Carità	Novara		Italy	28100
53	Azienda Ospedaliero-Universitaria	Parma		Italy
54	Ospedale Santo Spirito	Pescara		Italy	65100
55	Ospedale Guglielmo da Saliceto	Piacenza		Italy	29100
56	Azienda Ospedaliera Universitaria Pisana	Pisa		Italy	56100
57	Università La Sapienza	Roma		Italy	00161
58	Ospedale S. Vincenzo	Taormina		Italy	85123
59	Ospedale Moscati	Taranto		Italy	74100
60	Azienda Ospedaliera S. Maria	Terni		Italy
61	Ospedale Civile SS. Giovanni e Paolo	Venezia		Italy	30123
62	Samsung Medical Center	Seoul		Korea, Republic of	135-710
63	Nacional Cancer Institute	Bratislava		Slovakia	40138
64	Hospital Clinic de Barcelona	Barcelona		Spain	08036
65	Hospital Universitario	Salamanca		Spain
66	Kantonsspital	Aarau	AG	Switzerland	5001
67	Ospedale S. Giovanni	Bellinzona	TI	Switzerland	6500
68	Kantonsspital St. Gallen	St. Gallen		Switzerland	9007
69	University Hospital Birmingham NHS Foundation Trust	Birmingham		United Kingdom	B15 2TT
70	Barths and The London NHS Trust	London		United Kingdom	EC1A 7BE
71	Guy's and St. Thomas NHS Foundation Trust	London		United Kingdom	SE19RT
72	Christie Hospital NHS Foundation Trust	Manchester		United Kingdom	M20 4BX
73	Newcastle University	Newcastle upon Tyne		United Kingdom	NE17RU
74	University of Southampton School of Medicine	Southampton		United Kingdom	SO16 6YD
75	New Cross Hospital	Wolverhampton		United Kingdom	WV10 OQP
76	Hospital Maciel	Montevideo		Uruguay	11000

Sponsors and Collaborators

• Associazione Angela Serra per la ricerca sul cancro
• Fondazione Italiana Linfomi ONLUS
• INTERNATIONAL T-CELL NON-HODGKIN'S LYMPHOMA 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Associazione Angela Serra per la ricerca sul cancro
• ClinicalTrials.gov Identifier: NCT01142674
• Other Study ID Numbers: T-Cell Project
• First Posted: Jun 11, 2010
• Last Update Posted: Jul 8, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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

Study Results

No Results Posted as of Jul 8, 2019