Peripheral T-Cell LymphomaNCT03964480
Prospective Observational International Registry of Patients With Newly Diagnosed Peripheral T Cell Lymphoma.
An observational study of Peripheral T-Cell Lymphoma, run by Associazione Angela Serra per la ricerca sul cancro at 6 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T-Cell Lymphoma
- How many people
- 1,000 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 14 Oct 2018to 30 Jul 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Previously-untreated patients with de novo diagnosis of peripheral T-cell or NK/T-cell lymphoma:
Who may be able to join
- 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;
Show all 18Show fewer
- 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.
- Age 18 and over;
- Tissue biopsy adequate for diagnosis and classification and available for centralized review;
- 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;
- Written informed consent.
Who cannot join
- 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;
Show all 9Show fewer
- T-cell lymphoblastic lymphoma/leukemia
- T-cell prolymphocitic leukemia
- Age < 18.
Trial locations and contacts
6 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 4 countries
Italy3 sites, 3 recruiting
- Recruiting
IRCCS Istituto Tumori "Giovanni Paolo II"
Bari, 70124
Attilio Guarini, MD, 0039080/5555 905, attilioguarini@oncologico.bari.it
Angela Monica Sciacovelli, PhD, 0039080/5555 416, angelamonicasciacovelli@gmail.com
- Not yet recruiting
Palermo_La Maddalena
Palermo, 90146
Maurizio Musso, MD, 00 39 091-688 6801, mamusso53@gmail.com
Emilio Ianitto, MD, 00 39 091-680 6603, emilio.iannitto@gmail.com
- Not yet recruiting
Terni-Santa Maria
Terni, 05100
Anna Marina Liberati, MD, 00390744205971, marina.liberati@unipg.it
Viviana Appolloni, PhD, 00390744205971, appolloniviviana@gmail.com
United States1 site, 1 recruiting
- Not yet recruiting
Stanford University
Stanford, California, 94305
Ranjana Advani, MD, +16507256456, radvani@stanford.edu
Jessica Catherine Lam, MSc, PhD, +16507230437, jclam11@stanford.edu
Romania1 site, 1 recruiting
- Recruiting
Cluj Napoca_Ion Chiricuta Oncology Institute
Cluj-Napoca, 400015
Ciprian Tomuleasa, MD, 0040741337480, ciprian.tomuleasa@umfcluj.ro
Catalin Vlad, MD, 0040264598362, catalinvlad@yahoo.it
Ukraine1 site, 1 recruiting
- Recruiting
National Cancer Institute
Kiev, 03022
Iryna Kriachok, MD, +380442572156, irina.kryachok@gmail.com
Tetiana Skrypets, MD, +380502526606, skrip@ua.fm
About this study
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.
Read the 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.
- Conditions
- Peripheral T-Cell Lymphoma
- Keywords
- Peripheral T-Cell Lymphoma, Prognosis, Outcome, Biological Characteristics, Heterogeneity, Rare Diseases
- Medical subject headings
- Lymphoma, T-Cell, Peripheral, Rare Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Measured from the date of diagnosis until the date of disease progression or death from T-cell Lymphoma
Measured: 2 year
Secondary outcomes (4)
Overall Survival (OS)
Measured from the date of diagnosis until death from any cause
Measured: 3 and 5 year
Progression-Free Survival (PFS)
Measured from the date of diagnosis until the date of disease progression or death from T-cell Lymphoma
Measured: 3 and 5 years
Event Free Survival (EFS)
Measured from the date of diagnosis until the date of event
Measured: at 24 months
Complete Response Rate (CR)
Complete response rate at 30 months (CR30) after enrollment (i.e., initiation of treatment)
Measured: at 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start14 Oct 2018
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (46)Papers the sponsor has linked to this study.
- Other trials for Peripheral T-Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Associazione Angela Serra per la ricerca sul cancro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Massimo Federico, MD, Study director, University of Modena and Reggio Emilia, Centro Oncologico Modenese, Modena, ItalyAttilio 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, USASteven Horwitz, MD, Principal investigator, Memorial Sloan Kettering Cancer CenterMiles Prince, MD, Principal investigator, Peter MacCallum Cancer Center, Melbourne, AustraliaKim Won Seog, MD, Principal investigator, Hematology-Oncology Samsung Medical Center, Seoul, South KoreaDolores Caballero, MD, Principal investigator, Instituto Biosanitaria de Salamanca, Salamanca, SpainFrancesco Zaya, MD, Principal investigator, Azienda Sanitaria Universitaria Integrata S.M. Misericordia, Udine, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964480
- Sponsor's protocol ID
- T-Cell Project 2.0
- Status last verified
- Feb 2025
- First submitted
- 24 May 2019
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share with other involved researchers the minimum information on IPD for publication.
Publications
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.
PubMed 26850659Vose 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.
PubMed 18626005A clinical evaluation of the International Lymphoma Study Group classification of non-Hodgkin's lymphoma. The Non-Hodgkin's Lymphoma Classification Project. Blood. 1997 Jun 1;89(11):3909-18.
PubMed 9166827Savage KJ. Peripheral T-cell lymphomas. Blood Rev. 2007 Jul;21(4):201-16. doi: 10.1016/j.blre.2007.03.001. Epub 2007 May 18.
PubMed 17512649Iqbal J, Wright G, Wang C, Rosenwald A, Gascoyne RD, Weisenburger DD, Greiner TC, Smith L, Guo S, Wilcox RA, Teh BT, Lim ST, Tan SY, Rimsza LM, Jaffe ES, Campo E, Martinez A, Delabie J, Braziel RM, Cook JR, Tubbs RR, Ott G, Geissinger E, Gaulard P, Piccaluga PP, Pileri SA, Au WY, Nakamura S, Seto M, Berger F, de Leval L, Connors JM, Armitage J, Vose J, Chan WC, Staudt LM; Lymphoma Leukemia Molecular Profiling Project and the International Peripheral T-cell Lymphoma Project. Gene expression signatures delineate biological and prognostic subgroups in peripheral T-cell lymphoma. Blood. 2014 May 8;123(19):2915-23. doi: 10.1182/blood-2013-11-536359. Epub 2014 Mar 14.
PubMed 24632715Barbui T, Thiele J, Gisslinger H, Kvasnicka HM, Vannucchi AM, Guglielmelli P, Orazi A, Tefferi A. The 2016 WHO classification and diagnostic criteria for myeloproliferative neoplasms: document summary and in-depth discussion. Blood Cancer J. 2018 Feb 9;8(2):15. doi: 10.1038/s41408-018-0054-y.
PubMed 29426921Foss FM, Zinzani PL, Vose JM, Gascoyne RD, Rosen ST, Tobinai K. Peripheral T-cell lymphoma. Blood. 2011 Jun 23;117(25):6756-67. doi: 10.1182/blood-2010-05-231548. Epub 2011 Apr 14.
PubMed 21493798Weisenburger DD, Savage KJ, Harris NL, Gascoyne RD, Jaffe ES, MacLennan KA, Rudiger T, Pileri S, Nakamura S, Nathwani B, Campo E, Berger F, Coiffier B, Kim WS, Holte H, Federico M, Au WY, Tobinai K, Armitage JO, Vose JM; International Peripheral T-cell Lymphoma Project. Peripheral T-cell lymphoma, not otherwise specified: a report of 340 cases from the International Peripheral T-cell Lymphoma Project. Blood. 2011 Mar 24;117(12):3402-8. doi: 10.1182/blood-2010-09-310342. Epub 2011 Jan 26.
PubMed 21270441Gallamini A, Stelitano C, Calvi R, Bellei M, Mattei D, Vitolo U, Morabito F, Martelli M, Brusamolino E, Iannitto E, Zaja F, Cortelazzo S, Rigacci L, Devizzi L, Todeschini G, Santini G, Brugiatelli M, Federico M; Intergruppo Italiano Linfomi. Peripheral T-cell lymphoma unspecified (PTCL-U): a new prognostic model from a retrospective multicentric clinical study. Blood. 2004 Apr 1;103(7):2474-9. doi: 10.1182/blood-2003-09-3080. Epub 2003 Nov 26.
PubMed 14645001Went P, Agostinelli C, Gallamini A, Piccaluga PP, Ascani S, Sabattini E, Bacci F, Falini B, Motta T, Paulli M, Artusi T, Piccioli M, Zinzani PL, Pileri SA. Marker expression in peripheral T-cell lymphoma: a proposed clinical-pathologic prognostic score. J Clin Oncol. 2006 Jun 1;24(16):2472-9. doi: 10.1200/JCO.2005.03.6327. Epub 2006 Apr 24.
PubMed 16636342Lage LA, Cabral TC, Costa Rde O, Goncalves Mde C, Levy D, Zerbini MC, Pereira J. Primary nodal peripheral T-cell lymphomas: diagnosis and therapeutic considerations. Rev Bras Hematol Hemoter. 2015 Jul-Aug;37(4):277-84. doi: 10.1016/j.bjhh.2015.03.017. Epub 2015 Jun 7.
PubMed 26190436Dearden CE, Johnson R, Pettengell R, Devereux S, Cwynarski K, Whittaker S, McMillan A; British Committee for Standards in Haematology. Guidelines for the management of mature T-cell and NK-cell neoplasms (excluding cutaneous T-cell lymphoma). Br J Haematol. 2011 May;153(4):451-85. doi: 10.1111/j.1365-2141.2011.08651.x. Epub 2011 Apr 11.
PubMed 21480860Karakas T, Bergmann L, Stutte HJ, Jager E, Knuth A, Weidmann E, Mitrou PS, Hoelzer D. Peripheral T-cell lymphomas respond well to vincristine, adriamycin, cyclophosphamide, prednisone and etoposide (VACPE) and have a similar outcome as high-grade B-cell lymphomas. Leuk Lymphoma. 1996 Dec;24(1-2):121-9. doi: 10.3109/10428199609045720.
PubMed 9049968Schmitz N, Trumper L, Ziepert M, Nickelsen M, Ho AD, Metzner B, Peter N, Loeffler M, Rosenwald A, Pfreundschuh M. Treatment and prognosis of mature T-cell and NK-cell lymphoma: an analysis of patients with T-cell lymphoma treated in studies of the German High-Grade Non-Hodgkin Lymphoma Study Group. Blood. 2010 Nov 4;116(18):3418-25. doi: 10.1182/blood-2010-02-270785. Epub 2010 Jul 21.
PubMed 20660290d'Amore F, Gaulard P, Trumper L, Corradini P, Kim WS, Specht L, Bjerregaard Pedersen M, Ladetto M; ESMO Guidelines Committee. Peripheral T-cell lymphomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015 Sep;26 Suppl 5:v108-15. doi: 10.1093/annonc/mdv201. No abstract available.
PubMed 26314772
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational International Registry of Patients With Newly Diagnosed Peripheral T Cell Lymphoma.
- ClinicalTrials.gov ID
- NCT03964480
- Acronym / sponsor ID
- T-Cell Project 2.0
- Conditions
- Peripheral T-Cell Lymphoma
- Keywords
- Peripheral T-Cell Lymphoma, Prognosis, Outcome, Biological Characteristics, Heterogeneity, Rare Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Associazione Angela Serra per la ricerca sul cancroUniversity, hospital or other
- Study start
- 14 Oct 2018 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 28 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Previously-untreated patients with de novo diagnosis of peripheral T-cell or NK/T-cell lymphoma:
Key inclusion criteria (18 listed)
- Previously-untreated patients with de novo diagnosis of peripheral T-cell or NK/T-cell lymphoma:
- Age 18 and over;
- Tissue biopsy adequate for diagnosis and classification and available for centralized review;
- 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;
- Written informed consent.
Key exclusion criteria (9 listed)
- Diagnosis of:
- Age < 18.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-free survival (PFS)
Time frame: 2 year
Measured from the date of diagnosis until the date of disease progression or death from T-cell Lymphoma
4 secondary outcomes
Overall Survival (OS)
Time frame: 3 and 5 year
Progression-Free Survival (PFS)
Time frame: 3 and 5 years
Event Free Survival (EFS)
Time frame: at 24 months
Complete Response Rate (CR)
Time frame: at 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Background: PubMed 26850659Ansell 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.
- Background: PubMed 18626005Vose 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.
- Background: PubMed 9166827A clinical evaluation of the International Lymphoma Study Group classification of non-Hodgkin's lymphoma. The Non-Hodgkin's Lymphoma Classification Project. Blood. 1997 Jun 1;89(11):3909-18.
- Background: PubMed 17512649Savage KJ. Peripheral T-cell lymphomas. Blood Rev. 2007 Jul;21(4):201-16. doi: 10.1016/j.blre.2007.03.001. Epub 2007 May 18.
- Background: PubMed 24632715Iqbal J, Wright G, Wang C, Rosenwald A, Gascoyne RD, Weisenburger DD, Greiner TC, Smith L, Guo S, Wilcox RA, Teh BT, Lim ST, Tan SY, Rimsza LM, Jaffe ES, Campo E, Martinez A, Delabie J, Braziel RM, Cook JR, Tubbs RR, Ott G, Geissinger E, Gaulard P, Piccaluga PP, Pileri SA, Au WY, Nakamura S, Seto M, Berger F, de Leval L, Connors JM, Armitage J, Vose J, Chan WC, Staudt LM; Lymphoma Leukemia Molecular Profiling Project and the International Peripheral T-cell Lymphoma Project. Gene expression signatures delineate biological and prognostic subgroups in peripheral T-cell lymphoma. Blood. 2014 May 8;123(19):2915-23. doi: 10.1182/blood-2013-11-536359. Epub 2014 Mar 14.
- Background: PubMed 29426921Barbui T, Thiele J, Gisslinger H, Kvasnicka HM, Vannucchi AM, Guglielmelli P, Orazi A, Tefferi A. The 2016 WHO classification and diagnostic criteria for myeloproliferative neoplasms: document summary and in-depth discussion. Blood Cancer J. 2018 Feb 9;8(2):15. doi: 10.1038/s41408-018-0054-y.
- Background: PubMed 21493798Foss FM, Zinzani PL, Vose JM, Gascoyne RD, Rosen ST, Tobinai K. Peripheral T-cell lymphoma. Blood. 2011 Jun 23;117(25):6756-67. doi: 10.1182/blood-2010-05-231548. Epub 2011 Apr 14.
- Background: PubMed 21270441Weisenburger DD, Savage KJ, Harris NL, Gascoyne RD, Jaffe ES, MacLennan KA, Rudiger T, Pileri S, Nakamura S, Nathwani B, Campo E, Berger F, Coiffier B, Kim WS, Holte H, Federico M, Au WY, Tobinai K, Armitage JO, Vose JM; International Peripheral T-cell Lymphoma Project. Peripheral T-cell lymphoma, not otherwise specified: a report of 340 cases from the International Peripheral T-cell Lymphoma Project. Blood. 2011 Mar 24;117(12):3402-8. doi: 10.1182/blood-2010-09-310342. Epub 2011 Jan 26.
- Background: PubMed 14645001Gallamini A, Stelitano C, Calvi R, Bellei M, Mattei D, Vitolo U, Morabito F, Martelli M, Brusamolino E, Iannitto E, Zaja F, Cortelazzo S, Rigacci L, Devizzi L, Todeschini G, Santini G, Brugiatelli M, Federico M; Intergruppo Italiano Linfomi. Peripheral T-cell lymphoma unspecified (PTCL-U): a new prognostic model from a retrospective multicentric clinical study. Blood. 2004 Apr 1;103(7):2474-9. doi: 10.1182/blood-2003-09-3080. Epub 2003 Nov 26.
- Background: PubMed 16636342Went P, Agostinelli C, Gallamini A, Piccaluga PP, Ascani S, Sabattini E, Bacci F, Falini B, Motta T, Paulli M, Artusi T, Piccioli M, Zinzani PL, Pileri SA. Marker expression in peripheral T-cell lymphoma: a proposed clinical-pathologic prognostic score. J Clin Oncol. 2006 Jun 1;24(16):2472-9. doi: 10.1200/JCO.2005.03.6327. Epub 2006 Apr 24.
- Background: PubMed 26190436Lage LA, Cabral TC, Costa Rde O, Goncalves Mde C, Levy D, Zerbini MC, Pereira J. Primary nodal peripheral T-cell lymphomas: diagnosis and therapeutic considerations. Rev Bras Hematol Hemoter. 2015 Jul-Aug;37(4):277-84. doi: 10.1016/j.bjhh.2015.03.017. Epub 2015 Jun 7.
- Background: PubMed 21480860Dearden CE, Johnson R, Pettengell R, Devereux S, Cwynarski K, Whittaker S, McMillan A; British Committee for Standards in Haematology. Guidelines for the management of mature T-cell and NK-cell neoplasms (excluding cutaneous T-cell lymphoma). Br J Haematol. 2011 May;153(4):451-85. doi: 10.1111/j.1365-2141.2011.08651.x. Epub 2011 Apr 11.
- Individual participant dataSharing planned: Yes. We plan to share with other involved researchers the minimum information on IPD for publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral T-Cell Lymphoma, run by Associazione Angela Serra per la ricerca sul cancro at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy, United States, Romania, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martina Manni, MSc, PhD (+390594223284, marmanni@unimore.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03964480, which also lists 46 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.