RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2018-10-14

Study Completion:2025-07-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03964480

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Martina Manni, MSc, PhD

CONTACT

+390594223284

marmanni@unimore.it

Monica Civallero, MSc, PhD

CONTACT

+390594223475

monica.civallero@unimore.it

Principal Investigator

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 Locations (Sites)

Stanford University

Stanford, California, 94305

United States

Collaborators and Investigators

Sponsor: 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

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 Registration Dates

Study Start Date2018-10-14

Study Completion Date2025-07-30

Study Record Updates

Study Start Date2018-10-14

Study Completion Date2025-07-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Peripheral T-Cell Lymphoma