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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Associazione Angela Serra per la ricerca sul cancro
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01142674
First received: June 10, 2010
Last updated: May 21, 2014
Last verified: May 2014
  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 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.

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Event Free Survival (EFS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Remission rate with initial therapy [ Time Frame: End of front-line therapy ] [ Designated as safety issue: No ]
  • Progression Free Survival (PFS) [ Time Frame: 5-years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Formalin-fixed tissue for central diagnostic pathology review


Estimated Enrollment: 1300
Study Start Date: September 2006
Estimated Primary Completion Date: June 2014 (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-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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01142674

Contacts
Contact: Monica Bellei, MSc, PhD +39 059 422 4020 monica.bellei@unimore.it
Contact: Emanuela A. Pesce, MSc,PhD +39 059 422 3284 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: Raymond Liang, MD Queen Mary Hospital - University of Hong Kong, Hong Kong, HK
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 Istituto di Ematologia e Oncologia Medica "L. e A. Seragnoli", Policlinico Sant'Orsola, Bologna, IT
Study Chair: Dennis D. Weisenburger, MD Nebraska Medical Center, Omaha, NE, USA
Study Chair: Thomas Ruediger, MD Universitat Wurzburg, Wurzburg, DE
Study Chair: Young H. Ko, MD Samsung Medical Center, Seoul, KR
  More 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

Responsible Party: Associazione Angela Serra per la ricerca sul cancro
ClinicalTrials.gov Identifier: NCT01142674     History of Changes
Other Study ID Numbers: T-Cell Project
Study First Received: June 10, 2010
Last Updated: May 21, 2014
Health Authority: Italy: The Italian Medicines Agency

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

ClinicalTrials.gov processed this record on August 19, 2014