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Trial record 2 of 4 for:    T cell Brazil project

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01142674
Recruitment Status : Completed
First Posted : June 11, 2010
Last Update Posted : July 8, 2019
Fondazione Italiana Linfomi ONLUS
Information provided by (Responsible Party):
Associazione Angela Serra per la ricerca sul cancro

Tracking Information
First Submitted Date June 10, 2010
First Posted Date June 11, 2010
Last Update Posted Date July 8, 2019
Actual Study Start Date September 2006
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 10, 2010)
Overall Survival (OS) [ Time Frame: 5 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01142674 on Archive Site
Current Secondary Outcome Measures
 (submitted: June 10, 2010)
  • Event Free Survival (EFS) [ Time Frame: 5 years ]
  • Remission rate with initial therapy [ Time Frame: End of front-line therapy ]
  • Progression Free Survival (PFS) [ Time Frame: 5-years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title T-Cell Project: Prospective Collection of Data in Patients With Peripheral T-Cell Lymphoma
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
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

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Formalin-fixed tissue for central diagnostic pathology review
Sampling Method Non-Probability Sample
Study Population Previously-untreated patients with de novo diagnosis of peripheral T-cell or NK/T-cell lymphoma
Condition Lymphoma, T-Cell, Peripheral
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: July 3, 2019)
Original Estimated Enrollment
 (submitted: June 10, 2010)
Actual Study Completion Date December 2018
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil,   Argentina,   Chile,   China,   France,   Israel,   Italy,   Korea, Republic of,   Slovakia,   Spain,   Switzerland,   United Kingdom,   United States,   Uruguay
Removed Location Countries  
Administrative Information
NCT Number NCT01142674
Other Study ID Numbers T-Cell Project
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Preliminary analysis results will be made available during the study on the single population and separately for each subtype. Final results will be made available 6-12 months after the end of the study
Responsible Party Associazione Angela Serra per la ricerca sul cancro
Study Sponsor Associazione Angela Serra per la ricerca sul cancro
  • Fondazione Italiana Linfomi ONLUS
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
PRS Account Associazione Angela Serra per la ricerca sul cancro
Verification Date July 2019