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

NCT03964480 | Recruiting

• 1 other identifier: T-Cell Project 2.0
• Study Type: observational
• Target: 1,000
• Locations: 4 countries
• Sites: 6

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.

Conditions

Peripheral T-Cell Lymphoma

Keywords

Peripheral T-Cell Lymphoma; Prognosis; Outcome; Biological Characteristics; Heterogeneity; Rare Diseases

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  Measured from the date of diagnosis until the date of disease progression or death from T-cell Lymphoma

  2 year

Secondary Outcomes (4)

• Overall Survival (OS)

  3 and 5 year

• Progression-Free Survival (PFS)

  3 and 5 years

• Event Free Survival (EFS)

  at 24 months

• Complete Response Rate (CR)

  at 30 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.
• Age 18 and over;

You may not qualify if:

• 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
• Age \< 18.

Sponsors & Collaborators

• Associazione Angela Serra per la ricerca sul cancro: lead

Study Sites (6)

Stanford University

Stanford, California, 94305, United States

NOT YET RECRUITING

IRCCS Istituto Tumori "Giovanni Paolo II"

Bari, 70124, Italy

RECRUITING

Palermo_La Maddalena

Palermo, 90146, Italy

NOT YET RECRUITING

Terni-Santa Maria

Terni, 05100, Italy

NOT YET RECRUITING

Cluj Napoca_Ion Chiricuta Oncology Institute

Cluj-Napoca, 400015, Romania

RECRUITING

National Cancer Institute

Kiev, 03022, Ukraine

RECRUITING

Related Publications (46)

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Biospecimen

Retention: SAMPLES WITH DNA

Formalin-fixed tissue for central diagnostic pathology review; Peripheral blood samples.

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral; Rare Diseases

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Massimo Federico, MD

  University of Modena and Reggio Emilia, Centro Oncologico Modenese, Modena, Italy

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martina Manni, MSc, PhD

CONTACT

+390594223284; marmanni@unimore.it

Athina Lymboussakis, MSc, PhD

CONTACT

+390594223143; athina.lymboussakis@unimore.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: May 28, 2019
• Study Start: October 14, 2018
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (1); IT (3); UA (1); RO (1)