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

July 8, 2020 updated by: Associazione Angela Serra per la ricerca sul cancro

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

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

18 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:

    • 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 3 and 5 year
Measured from the date of diagnosis until death from any cause
3 and 5 year
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 and 5 years
Event Free Survival (EFS)
Time Frame: at 24 months
Measured from the date of diagnosis until the date of event
at 24 months
Complete Response Rate (CR)
Time Frame: at 30 months
Complete response rate at 30 months (CR30) after enrollment (i.e., initiation of treatment)
at 30 months

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

Investigators

  • 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: 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

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)

October 14, 2018

Primary Completion (ANTICIPATED)

January 30, 2023

Study Completion (ANTICIPATED)

July 30, 2025

Study Registration Dates

First Submitted

May 24, 2019

First Submitted That Met QC Criteria

May 24, 2019

First Posted (ACTUAL)

May 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 9, 2020

Last Update Submitted That Met QC Criteria

July 8, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T-Cell Project 2.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan to share with other involved researchers the minimum information on IPD for publication.

IPD Sharing 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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