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Brief Title: Prospective Observational International Registry of Patients With Newly Diagnosed Peripheral T Cell Lymphoma.
Official Title: Prospective Observational International Registry of Patients With Newly Diagnosed Peripheral T Cell Lymphoma.
Study ID: NCT03964480
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.
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Stanford University, Stanford, California, United States
IRCCS Istituto Tumori "Giovanni Paolo II", Bari, , Italy
Palermo_La Maddalena, Palermo, , Italy
Terni-Santa Maria, Terni, , Italy
Cluj Napoca_Ion Chiricuta Oncology Institute, Cluj Napoca, , Romania
National Cancer Institute, Kiev, , Ukraine
Name: Massimo Federico, MD
Affiliation: University of Modena and Reggio Emilia, Centro Oncologico Modenese, Modena, Italy
Role: STUDY_DIRECTOR
Name: Attilio Guarini, MD
Affiliation: U.O. Ematologia, IRCCS Istituto Tumori "Giovanni Paolo II"
Role: PRINCIPAL_INVESTIGATOR
Name: Julie Vose, MD
Affiliation: Section of Hematology/Oncology, Nebraska Medical Center, USA
Role: PRINCIPAL_INVESTIGATOR
Name: Steven Horwitz, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Miles Prince, MD
Affiliation: Peter MacCallum Cancer Center, Melbourne, Australia
Role: PRINCIPAL_INVESTIGATOR
Name: Kim Won Seog, MD
Affiliation: Hematology-Oncology Samsung Medical Center, Seoul, South Korea
Role: PRINCIPAL_INVESTIGATOR
Name: Dolores Caballero, MD
Affiliation: Instituto Biosanitaria de Salamanca, Salamanca, Spain
Role: PRINCIPAL_INVESTIGATOR
Name: Francesco Zaya, MD
Affiliation: Azienda Sanitaria Universitaria Integrata S.M. Misericordia, Udine, Italy
Role: PRINCIPAL_INVESTIGATOR
Name: Stefano Luminari, MD
Affiliation: S.C. Ematologia, Arcispedale S. Maria Nuova-IRCCS, Reggio Emilia, Italy
Role: PRINCIPAL_INVESTIGATOR
Name: Ranjana Advani, MD
Affiliation: Stanford University Medical Center, Stanford, CA, USA
Role: PRINCIPAL_INVESTIGATOR
Name: Andrei Shustov, MD
Affiliation: Seattle Cancer Care Alliance, Seattle, WA, USA
Role: PRINCIPAL_INVESTIGATOR
Name: Pierluigi Porcu, MD
Affiliation: Hematopoietic Stem Cell Transplantation, Sidney Kimmel Cancer Center, USA
Role: PRINCIPAL_INVESTIGATOR
Name: Astrid Pavlovsky, MD
Affiliation: Centro de Hematologia, FUNDALEU, Buenos Aires, Argentina
Role: PRINCIPAL_INVESTIGATOR
Name: Carlos Chiattone, MD
Affiliation: Departamento de Clinica Médica, FCM da Santa Casa de Sao Paulo, Sao Paulo, Brazil
Role: PRINCIPAL_INVESTIGATOR
Name: Francine Foss, MD
Affiliation: Yale University School of Medicine, New Haven, CT, USA
Role: PRINCIPAL_INVESTIGATOR
Name: Christopher Fox, MD
Affiliation: Clinical Haematology, Nottingham University Hospitals NHS Trust, Nottingham, UK
Role: PRINCIPAL_INVESTIGATOR