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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Peripheral T-Cell Lymphoma
Intervention / Treatment

-

Contacts and Locations

Stanford

Stanford University, Stanford, California, United States, 94305

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Associazione Angela Serra per la ricerca sul cancro,

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

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

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

Steven Horwitz, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Miles Prince, MD, PRINCIPAL_INVESTIGATOR, Peter MacCallum Cancer Center, Melbourne, Australia

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

Dolores Caballero, MD, PRINCIPAL_INVESTIGATOR, Instituto Biosanitaria de Salamanca, Salamanca, Spain

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

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

Ranjana Advani, MD, PRINCIPAL_INVESTIGATOR, Stanford University Medical Center, Stanford, CA, USA

Andrei Shustov, MD, PRINCIPAL_INVESTIGATOR, Seattle Cancer Care Alliance, Seattle, WA, USA

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

Astrid Pavlovsky, MD, PRINCIPAL_INVESTIGATOR, Centro de Hematologia, FUNDALEU, Buenos Aires, Argentina

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

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

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

Study Record Dates

2025-07-30