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

July 3, 2019 updated by: Associazione Angela Serra per la ricerca sul cancro

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

Study Overview

Status

Completed

Conditions

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

Enrollment (Anticipated)

1650

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1114AAN
        • Fundacion Fundaleu
    • Buenos Aires
      • La Plata, Buenos Aires, Argentina, 1896
        • Hospital Italiano
      • La Plata, Buenos Aires, Argentina, 1900
        • Hospital San Martin
  • Brazil
      • Sao Paulo, Brazil, 01223
        • Santa Casa Medical School
    • SP
      • Campinas, SP, Brazil, 13083-97
        • University of Campinas
  • Chile
      • Santiago de Chile, Chile, 3580000
        • Hospital del Salvador SSMO
  • China
      • Hong Kong, China
        • Queen Mary Hospital
      • Hong Kong, China
        • Tuen Mun Hospital
      • Hong Kong, China
        • Princess Margaret Hospital
  • France
      • Paris, France
        • Hopital St Louis
  • Israel
      • Tel-Aviv, Israel, 64239
        • Sourasky Medical Center
      • Tel-Aviv, Israel, 52621
        • Sheba Medical Center
  • Italy
      • Bologna, Italy, 40138
        • Istituto di Ematologia A & Seragnoli
      • Bolzano, Italy, 39100
        • Ospedale Centrale di Bolzano
      • Brindisi, Italy, 72100
        • Ospedale A. Perrino
      • Cagliari, Italy, 09121
        • Ospedale Oncologico A. Businco
      • Catanzaro, Italy, 88100
        • Azienda Ospedaliera Pugliese-Ciaccio
      • Firenze, Italy, 50134
        • Azienda Ospedaliera Universitaria Careggi
      • La Spezia, Italy, 19100
        • Ospedale Felettino
      • Milano, Italy, 20122
        • Fondazione Policlinico MaRe IRCCS
      • Napoli, Italy, 80130
        • Azienda Ospedaliera Universitaria Federico II
      • Novara, Italy, 28100
        • Azienda Ospedaliera Maggiore Della Carita
      • Parma, Italy
        • Azienda Ospedaliero-Universitaria
      • Pescara, Italy, 65100
        • Ospedale Santo Spirito
      • Piacenza, Italy, 29100
        • Ospedale Guglielmo da Saliceto
      • Pisa, Italy, 56100
        • Azienda Ospedaliera Universitaria Pisana
      • Roma, Italy, 00161
        • Università La Sapienza
      • Taormina, Italy, 85123
        • Ospedale S. Vincenzo
      • Taranto, Italy, 74100
        • Ospedale Moscati
      • Terni, Italy
        • Azienda Ospedaliera S. Maria
      • Venezia, Italy, 30123
        • Ospedale Civile SS. Giovanni e Paolo
    • BS
      • Brescia, BS, Italy, 25123
        • Presidio Spedali Civili
    • CN
      • Cuneo, CN, Italy, 12100
        • Azienda Ospedaliera S. Croce e Carle
    • CT
      • Catania, CT, Italy, 95123
        • Presidio Ospedaliero Garibaldi-Nesima
      • Catania, CT, Italy, 95124
        • Azienda O.U. Vittorio Emanuele-Ferrarotto-S. Bambino
    • CZ
      • Catanzaro, CZ, Italy, 88100
        • Azienda Ospedaliera Pugliese-Ciaccio
    • FG
      • San Giovanni Rotondo, FG, Italy, 71013
        • Ospedale Casa Sollievo Della Sofferenza IRCCS
    • LE
      • Lecce, LE, Italy, 73100
        • Azienda Ospedaliera Vito Fazzi
    • ME
      • Messina, ME, Italy, 98158
        • Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte
    • MI
      • Milano, MI, Italy, 20089
        • Istituto Clinico Humanitas
      • Milano, MI, Italy, 20132
        • Istituto Scientifico Universitario San Raffaele
      • Milano, MI, Italy, 20142
        • Istituto Europeo di Oncologia
      • Milano, MI, Italy
        • Azienda Ospedaliera Ospedale Niguarda Ca' Franda
    • MO
      • Modena, MO, Italy, 41124
        • Centro Oncologico Modenese
    • Macerata
      • Civitanova Marche, Macerata, Italy, 62012
        • Ospedale Civile
    • Mount
      • Matera, Mount, Italy, 75100
        • Ospedale Madonna delle Grazie
    • PD
      • Padova, PD, Italy, 35128
        • Istituto Oncologico Veneto
    • Pa
      • Palermo, Pa, Italy, 90100
        • Casa di Cura La Maddalena
    • Pordenone
      • Aviano, Pordenone, Italy, 33081
        • Centro Di Riferimento Oncologico
    • RC
      • Reggio Calabria, RC, Italy, 89100
        • Azienda Ospedaliera Bianchi-Melacrino-Morelli
    • RE
      • Reggio Emilia, RE, Italy, 42100
        • Arcispedale S. Maria Nuova
    • SA
      • Nocera Inferiore, SA, Italy, 84014
        • Presidio Ospedaliero Umberto I
    • TO
      • Torino, TO, Italy, 10126
        • Azienda Ospedaliera S. Giovanni Battista
  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
  • Slovakia
      • Bratislava, Slovakia, 40138
        • Nacional Cancer Institute
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic De Barcelona
      • Salamanca, Spain
        • Hospital Universitario
  • Switzerland
      • St. Gallen, Switzerland, 9007
        • Kantonsspital St. Gallen
    • AG
      • Aarau, AG, Switzerland, 5001
        • Kantonsspital
    • TI
      • Bellinzona, TI, Switzerland, 6500
        • Ospedale S. Giovanni
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TT
        • University Hospital Birmingham NHS foundation Trust
      • London, United Kingdom, EC1A 7BE
        • Barths and The London NHS Trust
      • London, United Kingdom, SE19RT
        • Guy's and St. Thomas NHS Foundation Trust
      • Manchester, United Kingdom, M20 4BX
        • Christie Hospital NHS Foundation Trust
      • Newcastle upon Tyne, United Kingdom, NE17RU
        • Newcastle University
      • Southampton, United Kingdom, SO16 6YD
        • University of Southampton School of Medicine
      • Wolverhampton, United Kingdom, WV10 OQP
        • New Cross Hospital
  • United States
    • California
      • Palo Alto, California, United States, 94301
        • Stanford University Medical Center
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale Cancer Center
    • Missouri
      • Saint Louis, Missouri, United States, 63130
        • St Louis Washington University
    • Nebraska
      • Omaha, Nebraska, United States, 68022
        • University of Nebraska Medical Center
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, United States, 98101
        • Fred Hutchinson Cancer Research Center
  • Uruguay
      • Montevideo, Uruguay, 11000
        • Hospital Maciel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Previously-untreated patients with de novo diagnosis of peripheral T-cell or NK/T-cell lymphoma

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Event Free Survival (EFS)
Time Frame: 5 years
5 years
Remission rate with initial therapy
Time Frame: End of front-line therapy
End of front-line therapy
Progression Free Survival (PFS)
Time Frame: 5-years
5-years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Associazione Angela Serra per la ricerca sul cancro

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2006

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

June 10, 2010

First Submitted That Met QC Criteria

June 10, 2010

First Posted (Estimate)

June 11, 2010

Study Record Updates

Last Update Posted (Actual)

July 8, 2019

Last Update Submitted That Met QC Criteria

July 3, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T-Cell Project

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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