NCT01142674 — T-Cell Project: Prospective Collection of Data in Patients With Peripheral T-Cell Lymphoma · CancerIndex
Clinical trial · Observational
T-Cell Project: Prospective Collection of Data in Patients With Peripheral T-Cell Lymphoma
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
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
References
Publications (25)
BACKGROUNDHarris 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
BACKGROUNDJones 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
BACKGROUNDPicker 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
BACKGROUNDCooke 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
BACKGROUNDMelnyk 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
BACKGROUNDArmitage 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
BACKGROUNDAscani 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.
BACKGROUNDLopez-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
BACKGROUNDSavage 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
BACKGROUNDGallamini 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
BACKGROUNDZaja 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
BACKGROUNDTsuchiya 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
RESULTFederico 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.
RESULTFederico 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
RESULTBellei 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
RESULTFederico 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
RESULTFederico 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
RESULTBellei 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
RESULTHorwitz 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
RESULTBellei 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
DERIVEDChiattone 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
DERIVEDAdvani 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
DERIVEDShustov 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
DERIVEDFox 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
DERIVEDBellei 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
Switzerland
3
0
China
3
0
Argentina
3
0
Spain
2
0
Israel
2
0
Brazil
2
0
South Korea
1
0
Slovakia
1
0
France
1
0
Uruguay
1
0
Chile
1
0
Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.