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

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Lymphoma, T-Cell, Peripheral
Monica Bellei, MSc, PhD
+39 059 422 4020
See all trial contact details
Primary Contact Details
Recruiting
Recruitment Status
NCT01142674
Primary Trial ID Number
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
Research Details
  • 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-u, the Intergruppo Italiano Linfomi (IIL) 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-u, the IIL 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.
Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Study Type
Observational
Intervention
Sorry, this information is not available
Intervention Type
See Interventions above
Primary Outcome Measures
  • Overall Survival (OS); 5 years
Secondary Outcome Measures
  • Event Free Survival (EFS); 5 years; Remission rate with initial therapy; End of front-line therapy; Progression Free Survival (PFS); 5-years
Publication(s)
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.; null; 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; null; 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.; 23049383
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
1300
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Christie Hospital NHS Foundation Trust
Manchester
M20 4BX
Southampton General Hospital
Southampton
England
SO16 6YD
Cancer Research UK Clinical Trials Unit - Birmingham
Birmingham
England
B15 2TT
St. Bartholomew's and The Royal London Hospital
London
EC1A 7BE
Local Institution
London
Greater London
SE19RT
Royal Wolverhampton Hospitals Trust - Research and Development
Wolverhampton
WV10 OQP
Newcastle University
Newcastle upon Tyne
NE17RU
Trial Contact(s)
Primary Trial Contact
Monica Bellei, MSc, PhD
monica.bellei@unimore.it
+39 059 422 4020
Other Trial Contacts
Emanuela A. Pesce, MSc,PhD
emanuelaanna.pesce@unimore.it
+39 059 422 3284
Countries Recruiting
United States, Argentina, Brazil, Chile, China, France, Israel, Italy, Korea, Republic of, Slovakia, Spain, Switzerland, United Kingdom, Uruguay
Scientific Title
Prospective Collection of Data in Patients With Peripheral T-Cell Lymphoma: PTCL,NOS;AITL; Extranodal NK/T-cell;Enteropathy-type T-cell; Hepatosplenic γ-δ T-cell; Subcutaneous Panniculitis-like T-cell; ALCL,T/Null Cell,Primary Systemic Type. From the International T-Cell Lymphoma Project.
EudraCT Number
Not available for this trial
Funder(s)
  • Fondazione Italiana Linfomi ONLUS
  • International Peripheral T-Cell Lymphoma Project (Study group)
Other Study ID Numbers
T-Cell Project
Sponsor(s)
Associazione Angela Serra per la ricerca sul cancro
Key Dates

Recruitment Start Date

Sep 2006

Recruitment End Date

Jun 2016

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

10 Jun 2010

Last Updated

13 Jan 2015