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

NCT03964480 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2025-05-06

No results posted yet for this study

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

Sponsors & Collaborators

  • Associazione Angela Serra per la ricerca sul cancro

    lead OTHER

Principal Investigators

  • Massimo Federico, MD · University of Modena and Reggio Emilia, Centro Oncologico Modenese, Modena, Italy

  • Attilio Guarini, MD · U.O. Ematologia, IRCCS Istituto Tumori "Giovanni Paolo II"

  • Julie Vose, MD · Section of Hematology/Oncology, Nebraska Medical Center, USA

  • Steven Horwitz, MD · Memorial Sloan Kettering Cancer Center

  • Miles Prince, MD · Peter MacCallum Cancer Center, Melbourne, Australia

  • Kim Won Seog, MD · Hematology-Oncology Samsung Medical Center, Seoul, South Korea

  • Dolores Caballero, MD · Instituto Biosanitaria de Salamanca, Salamanca, Spain

  • Francesco Zaya, MD · Azienda Sanitaria Universitaria Integrata S.M. Misericordia, Udine, Italy

  • Stefano Luminari, MD · S.C. Ematologia, Arcispedale S. Maria Nuova-IRCCS, Reggio Emilia, Italy

  • Ranjana Advani, MD · Stanford University Medical Center, Stanford, CA, USA

  • Andrei Shustov, MD · Seattle Cancer Care Alliance, Seattle, WA, USA

  • Pierluigi Porcu, MD · Hematopoietic Stem Cell Transplantation, Sidney Kimmel Cancer Center, USA

  • Astrid Pavlovsky, MD · Centro de Hematologia, FUNDALEU, Buenos Aires, Argentina

  • Carlos Chiattone, MD · Departamento de Clinica Médica, FCM da Santa Casa de Sao Paulo, Sao Paulo, Brazil

  • Francine Foss, MD · Yale University School of Medicine, New Haven, CT, USA

  • Christopher Fox, MD · Clinical Haematology, Nottingham University Hospitals NHS Trust, Nottingham, UK

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-14
Primary Completion
2025-07-30
Completion
2025-07-30

Countries

  • United States
  • Italy
  • Romania
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03964480 on ClinicalTrials.gov