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Prospective Observational International Registry of Patients With Newly Diagnosed Peripheral T Cell Lymphoma.

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ClinicalTrials.gov Identifier: NCT03964480
Recruitment Status : Recruiting
First Posted : May 27, 2019
Last Update Posted : May 27, 2019
Sponsor:
Information provided by (Responsible Party):
Associazione Angela Serra per la ricerca sul cancro

Brief Summary:

This study T-Cell Project 2.0 is based on the former International PTCL study designed by the International T-cell Non-Hodgkin's Lymphoma Study Group (T-Cell Project 1.0: Prospective Collection of Data in Patients With Peripheral T-Cell Lymphoma) as a prospective collection of data to predict the prognosis of patients with the more frequent subtypes of PTCL. It is a prospective, longitudinal, international, observational study of patients with newly diagnosed peripheral T-cell lymphoma aiming to verify whether this prospective collection of data would allow achieving a more accurate information on T-cell lymphomas.

The study aims to better define the clinical relevance of the new WHO Classification, the role of FDG-PET in staging and response assessment, the prognosis of different entities, the genomic landscape of different subtypes, and to investigate on most optimal treatment strategies for these neoplasms in the real-world population as well as molecular markers and to explore the prognostic or predictive implications of them in PTCL.

The study aims to better define the clinical relevance of the new WHO Classification, the role of FDG-PET in staging and response assessment, the prognosis of different entities, the genomic landscape of different subtypes, and to investigate on most optimal treatment strategies for these neoplasms in the real-world population.


Condition or disease
Peripheral T-Cell Lymphoma

Detailed Description:

Peripheral T-cell non-Hodgkin lymphomas (PTCLs) are a heterogeneous group of lymphoproliferative disorder arising from mature T cells of post-thymic origin at different stages of differentiation with different morphological patterns, phenotypes, and clinical presentation. All subtypes are found more commonly in male patients, and the median age at diagnosis is 62 years. This disease is generally associated with high relapse rates and a poor prognosis, with inferior treatment outcomes compared with B-cell lymphomas and have a 5-year-survival < 32%.

T-cell lymphomas are widely recognized as a complex and heterogeneous group of lymphoproliferative disorders, generally associated with high relapse rates and a poor prognosis. Because of their rarity, they are still very poorly understood.

The introduction of new and more effective therapies and better technologies led the International T-cell non-Hodgkin's Lymphoma Study Group to launch the T-cell Project 2.0 in order to have a contemporary, real-time understanding of the T-cell lymphoma biology and treatment, together with the application of contemporary technologies to further identification of new therapeutic targets.

Per protocol, patients are evaluated according to the treating physician's standard practice. There are no specific evaluations or visits required for the Registry. Data captured in the Registry reflects what is routinely collected for patients with PTCL.

The study plans to collect the tissue sample for central review. The ordinary fixation, cryopreservation and routine tumor cytogenetics are planned for biopsy samples. Chairmen of the Histopathology Review Panel will locate Regional sites where expert hematopathologists will review the material and perform a panel of immunostains (T-cell panel + CD20) and markers not assessed at local site.

Adding of blood sample collection will allow estimating prospectively the frequency of pEBVd detection in our cohort of PTCL patients at baseline and at the end of initial therapy, to characterize agreement between pEBVd and EBER in tumor tissue, and to explore the prognostic or predictive implications of detectable pEBVd in PTCL. Finally, to investigate the genetics and pathogenic mechanisms of aggressive PTCLs on an international scale.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Prospective Observational International Registry of Patients With Newly Diagnosed Peripheral T Cell Lymphoma.
Actual Study Start Date : October 14, 2018
Estimated Primary Completion Date : January 30, 2023
Estimated Study Completion Date : July 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma




Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: 2 year ]
    Measured from the date of diagnosis until the date of disease progression or death from T-cell Lymphoma


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 3 and 5 year ]
    Measured from the date of diagnosis until death from any cause

  2. Progression-Free Survival (PFS) [ Time Frame: 3 and 5 years ]
    Measured from the date of diagnosis until the date of disease progression or death from T-cell Lymphoma

  3. Event Free Survival (EFS) [ Time Frame: at 24 months ]
    Measured from the date of diagnosis until the date of event

  4. Complete Response Rate (CR) [ Time Frame: at 30 months ]
    Complete response rate at 30 months (CR30) after enrollment (i.e., initiation of treatment)


Biospecimen Retention:   Samples With DNA
Formalin-fixed tissue for central diagnostic pathology review; Peripheral blood samples.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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:

    • T-cell large granular lymphocytic leukaemia;
    • Chronic lymphoproliferative disorder of NK cells;
    • Aggressive NK-cell leukaemia;
    • Adult T-cell leukaemia/lymphoma;
    • Extranodal NK/T-cell lymphoma, nasal type;
    • Intestinal T-cell lymphoma;
    • Hepatosplenic T-cell lymphoma;
    • Subcutaneous panniculitis-like T-cell lymphoma;
    • Peripheral T-cell lymphoma, not otherwise specified;
    • Angioimmunoblastic T-cell lymphoma and other nodal lymphomas of T follicular helper cell origin;
    • Anaplastic large cell lymphoma, ALK-positive;
    • Anaplastic large cell lymphoma, ALK-negative;
    • Breast implant-associated anaplastic large cell lymphoma.
  2. Age 18 and over;
  3. Tissue biopsy 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 2 years are requested;
  5. Written informed consent.

Exclusion Criteria:

  1. Diagnosis of:

    • EBV-positive T-cell and NK-cell lymphoproliferative diseases of childhood
    • Mycosis fungoides;
    • Sézary syndrome;
    • Primary cutaneous CD30-positive T-cell lymphoproliferative disorders;
    • Primary cutaneous peripheral T-cell lymphomas, rare subtypes;
    • T-cell lymphoblastic lymphoma/leukemia
    • T-cell prolymphocitic leukemia
  2. Age < 18.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964480


Contacts
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Contact: Martina Manni, MSc, PhD +390594223284 marmanni@unimore.it
Contact: Monica Civallero, MSc, PhD +390594223475 monica.civallero@unimore.it

Locations
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United States, California
Stanford University Not yet recruiting
Stanford, California, United States, 94305
Contact: Ranjana Advani, MD    650-725-6456    radvani@stanford.edu   
Contact: Jessica Catherine Lam, MSc, PhD    +16507230437    jclam11@stanford.edu   
Italy
IRCCS Istituto Tumori "Giovanni Paolo II" Recruiting
Bari, Italy, 70124
Contact: Attilio Guarini, MD    0039080/5555 905    attilioguarini@oncologico.bari.it   
Contact: Angela Monica Sciacovelli, PhD    0039080/5555 416    angelamonicasciacovelli@gmail.com   
Palermo_La Maddalena Not yet recruiting
Palermo, Italy, 90146
Contact: Maurizio Musso, MD    00 39 091-688 6801    mamusso53@gmail.com   
Contact: Emilio Ianitto, MD    00 39 091-680 6603    emilio.iannitto@gmail.com   
Terni-Santa Maria Not yet recruiting
Terni, Italy, 05100
Contact: Anna Marina Liberati, MD    00390744205971    marina.liberati@unipg.it   
Contact: Viviana Appolloni, PhD    00390744205971    appolloniviviana@gmail.com   
Romania
Cluj Napoca_Ion Chiricuta Oncology Institute Recruiting
Cluj Napoca, Romania, 400015
Contact: Ciprian Tomuleasa, MD    0040741337480    ciprian.tomuleasa@umfcluj.ro   
Contact: Catalin Vlad, MD    0040264598362    catalinvlad@yahoo.it   
Ukraine
National Cancer Institute Recruiting
Kiev, Ukraine, 03022
Contact: Iryna Kriachok, MD    +380442572156    irina.kryachok@gmail.com   
Contact: Tetiana Skrypets, MD    +380502526606    skrip@ua.fm   
Sponsors and Collaborators
Associazione Angela Serra per la ricerca sul cancro
Investigators
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Study Director: Massimo Federico, MD University of Modena and Reggio Emilia, Centro Oncologico Modenese, Modena, Italy
Principal Investigator: Attilio Guarini, MD U.O. Ematologia, IRCCS Istituto Tumori "Giovanni Paolo II"
Principal Investigator: Julie Vose, MD Section of Hematology/Oncology, Nebraska Medical Center, USA
Principal Investigator: Steven Horwitz, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Miles Prince, MD Peter MacCallum Cancer Center, Melbourne, Australia
Principal Investigator: Kim Won Seog, MD Hematology-Oncology Samsung Medical Center, Seoul, South Korea
Principal Investigator: Dolores Caballero, MD Instituto Biosanitaria de Salamanca, Salamanca, Spain
Principal Investigator: Francesco Zaya, MD Azienda Sanitaria Universitaria Integrata S.M. Misericordia, Udine, Italy
Principal Investigator: Stefano Luminari, MD S.C. Ematologia, Arcispedale S. Maria Nuova-IRCCS, Reggio Emilia, Italy
Principal Investigator: Ranjana Advani, MD Stanford University Medical Center, Stanford, CA, USA
Principal Investigator: Andrei Shustov, MD Seattle Cancer Care Alliance, Seattle, WA, USA
Principal Investigator: Pierluigi Porcu, MD Hematopoietic Stem Cell Transplantation, Sidney Kimmel Cancer Center, USA
Principal Investigator: Astrid Pavlovsky, MD Centro de Hematologia, FUNDALEU, Buenos Aires, Argentina
Principal Investigator: Carlos Chiattone, MD Departamento de Clinica Médica, FCM da Santa Casa de Sao Paulo, Sao Paulo, Brazil
Principal Investigator: Francine Foss, MD Yale University School of Medicine, New Haven, CT, USA
Principal Investigator: Christopher Fox, MD Clinical Haematology, Nottingham University Hospitals NHS Trust, Nottingham, UK

Additional Information:
Study Data/Documents: Printed book  This link exits the ClinicalTrials.gov site
Identifier: ISBN-13 (Print Book)

Publications:
Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo Español de Médula Ósea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68.

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Responsible Party: Associazione Angela Serra per la ricerca sul cancro
ClinicalTrials.gov Identifier: NCT03964480     History of Changes
Other Study ID Numbers: T-Cell Project 2.0
First Posted: May 27, 2019    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We plan to share with other involved researchers the minimum information on IPD for publication.
Time Frame: Preliminary analysis results will be made available during the study on the single population and separately for each sub-type. Final results will be made available 6-12 months after the end of the study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Associazione Angela Serra per la ricerca sul cancro:
Peripheral T-Cell Lymphoma
Prognosis
Outcome
Biological Characteristics
Heterogeneity
Rare Diseases
Additional relevant MeSH terms:
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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