NCT03964480|Recruiting
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Sponsor study identifier
observational
1,000
4 countries
6
Study Start
October 14, 2018
Actual (reported)Primary Completion
July 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 14, 2018
Actual (reported)May 24, 2019
Actual (reported)May 28, 2019
Actual (reported)July 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Progression-free survival (PFS)
Measured from the date of diagnosis until the date of disease progression or death from T-cell Lymphoma
2 year
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
Previously-untreated patients with de novo diagnosis of peripheral T-cell or NK/T-cell lymphoma:
Stanford University
Stanford, California, 94305, United States
IRCCS Istituto Tumori "Giovanni Paolo II"
Bari, 70124, Italy
Ansell S. How to select the frontline treatment for a patient with peripheral T-cell lymphoma. Leuk Lymphoma. 2016;57(4):783-8. doi: 10.3109/10428194.2016.1140760. Epub 2016 Feb 5.
Vose J, Armitage J, Weisenburger D; International T-Cell Lymphoma Project. International peripheral T-cell and natural killer/T-cell lymphoma study: pathology findings and clinical outcomes. J Clin Oncol. 2008 Sep 1;26(25):4124-30. doi: 10.1200/JCO.2008.16.4558. Epub 2008 Jul 14.
Formalin-fixed tissue for central diagnostic pathology review; Peripheral blood samples.
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
First Submitted
May 24, 2019
First Posted
May 28, 2019
Study Start
October 14, 2018
Actual (reported)Primary Completion
July 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Efficacy and Safety of CDOP vs CHOP for Newly Diagnosed Peripheral T-cell Lymphoma
Contact the study team to confirm eligibility.
Palermo_La Maddalena
Palermo, 90146, Italy
Terni-Santa Maria
Terni, 05100, Italy
Cluj Napoca_Ion Chiricuta Oncology Institute
Cluj-Napoca, 400015, Romania
National Cancer Institute
Kiev, 03022, Ukraine
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Zinzani PL, Venturini F, Stefoni V, Fina M, Pellegrini C, Derenzini E, Gandolfi L, Broccoli A, Argnani L, Quirini F, Pileri S, Baccarani M. Gemcitabine as single agent in pretreated T-cell lymphoma patients: evaluation of the long-term outcome. Ann Oncol. 2010 Apr;21(4):860-863. doi: 10.1093/annonc/mdp508. Epub 2009 Nov 3.
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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
Study Completion
July 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 6, 2025
Record last verified: 2025-02
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