Prospective Observational International Registry of Patients With Newly Diagnosed Peripheral T Cell Lymphoma.
NCT ID: NCT03964480
Last Updated: 2025-05-06
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
1000 participants
Study Classification
OBSERVATIONAL
Study Start Date
2018-10-14
Study Completion Date
2025-07-30
Brief Summary
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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.
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.
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Detailed Description
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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.
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
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Peripheral T-Cell Lymphoma
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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Inclusion 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.
* 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.
Exclusion Criteria
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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Associazione Angela Serra per la ricerca sul cancro
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Massimo Federico, MD
Role: STUDY_DIRECTOR
University of Modena and Reggio Emilia, Centro Oncologico Modenese, Modena, Italy
Attilio Guarini, MD
Role: PRINCIPAL_INVESTIGATOR
U.O. Ematologia, IRCCS Istituto Tumori "Giovanni Paolo II"
Julie Vose, MD
Role: PRINCIPAL_INVESTIGATOR
Section of Hematology/Oncology, Nebraska Medical Center, USA
Steven Horwitz, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Miles Prince, MD
Role: PRINCIPAL_INVESTIGATOR
Peter MacCallum Cancer Center, Melbourne, Australia
Kim Won Seog, MD
Role: PRINCIPAL_INVESTIGATOR
Hematology-Oncology Samsung Medical Center, Seoul, South Korea
Dolores Caballero, MD
Role: PRINCIPAL_INVESTIGATOR
Instituto Biosanitaria de Salamanca, Salamanca, Spain
Francesco Zaya, MD
Role: PRINCIPAL_INVESTIGATOR
Azienda Sanitaria Universitaria Integrata S.M. Misericordia, Udine, Italy
Stefano Luminari, MD
Role: PRINCIPAL_INVESTIGATOR
S.C. Ematologia, Arcispedale S. Maria Nuova-IRCCS, Reggio Emilia, Italy
Ranjana Advani, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University Medical Center, Stanford, CA, USA
Andrei Shustov, MD
Role: PRINCIPAL_INVESTIGATOR
Seattle Cancer Care Alliance, Seattle, WA, USA
Pierluigi Porcu, MD
Role: PRINCIPAL_INVESTIGATOR
Hematopoietic Stem Cell Transplantation, Sidney Kimmel Cancer Center, USA
Astrid Pavlovsky, MD
Role: PRINCIPAL_INVESTIGATOR
Centro de Hematologia, FUNDALEU, Buenos Aires, Argentina
Carlos Chiattone, MD
Role: PRINCIPAL_INVESTIGATOR
Departamento de Clinica Médica, FCM da Santa Casa de Sao Paulo, Sao Paulo, Brazil
Francine Foss, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University School of Medicine, New Haven, CT, USA
Christopher Fox, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Haematology, Nottingham University Hospitals NHS Trust, Nottingham, UK
Locations
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Stanford University
Stanford, California, United States
Site Status
NOT_YET_RECRUITING
IRCCS Istituto Tumori "Giovanni Paolo II"
Bari, , Italy
Site Status
RECRUITING
Palermo_La Maddalena
Palermo, , Italy
Site Status
NOT_YET_RECRUITING
Terni-Santa Maria
Terni, , Italy
Site Status
NOT_YET_RECRUITING
Cluj Napoca_Ion Chiricuta Oncology Institute
Cluj-Napoca, , Romania
Site Status
RECRUITING
National Cancer Institute
Kiev, , Ukraine
Site Status
RECRUITING
Countries
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United States
Italy
Romania
Ukraine
Central Contacts
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Facility Contacts
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References
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Coiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, Caballero D, Borchmann P, Morschhauser F, Wilhelm M, Pinter-Brown L, Padmanabhan S, Shustov A, Nichols J, Carroll S, Balser J, Balser B, Horwitz S. Results from a pivotal, open-label, phase II study of romidepsin in relapsed or refractory peripheral T-cell lymphoma after prior systemic therapy. J Clin Oncol. 2012 Feb 20;30(6):631-6. doi: 10.1200/JCO.2011.37.4223. Epub 2012 Jan 23.
Reference Type
BACKGROUND
Coiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, Caballero D, Morschhauser F, Wilhelm M, Pinter-Brown L, Padmanabhan Iyer S, Shustov A, Nielsen T, Nichols J, Wolfson J, Balser B, Horwitz S. Romidepsin for the treatment of relapsed/refractory peripheral T-cell lymphoma: pivotal study update demonstrates durable responses. J Hematol Oncol. 2014 Jan 23;7:11. doi: 10.1186/1756-8722-7-11.
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BACKGROUND
Pro B, Advani R, Brice P, Bartlett NL, Rosenblatt JD, Illidge T, Matous J, Ramchandren R, Fanale M, Connors JM, Yang Y, Sievers EL, Kennedy DA, Shustov A. Brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large-cell lymphoma: results of a phase II study. J Clin Oncol. 2012 Jun 20;30(18):2190-6. doi: 10.1200/JCO.2011.38.0402. Epub 2012 May 21.
Reference Type
BACKGROUND
Horwitz SM, Advani RH, Bartlett NL, Jacobsen ED, Sharman JP, O'Connor OA, Siddiqi T, Kennedy DA, Oki Y. Objective responses in relapsed T-cell lymphomas with single-agent brentuximab vedotin. Blood. 2014 May 15;123(20):3095-100. doi: 10.1182/blood-2013-12-542142. Epub 2014 Mar 20.
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BACKGROUND
Foss F, Advani R, Duvic M, Hymes KB, Intragumtornchai T, Lekhakula A, Shpilberg O, Lerner A, Belt RJ, Jacobsen ED, Laurent G, Ben-Yehuda D, Beylot-Barry M, Hillen U, Knoblauch P, Bhat G, Chawla S, Allen LF, Pohlman B. A Phase II trial of Belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T-cell lymphoma. Br J Haematol. 2015 Mar;168(6):811-9. doi: 10.1111/bjh.13222. Epub 2014 Nov 17.
Reference Type
BACKGROUND
O'Connor OA, Horwitz S, Masszi T, Van Hoof A, Brown P, Doorduijn J, Hess G, Jurczak W, Knoblauch P, Chawla S, Bhat G, Choi MR, Walewski J, Savage K, Foss F, Allen LF, Shustov A. Belinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma: Results of the Pivotal Phase II BELIEF (CLN-19) Study. J Clin Oncol. 2015 Aug 10;33(23):2492-9. doi: 10.1200/JCO.2014.59.2782. Epub 2015 Jun 22.
Reference Type
BACKGROUND
Bellei M, Sabattini E, Pesce EA, Ko YH, Kim WS, Cabrera ME, Martinez V, Dlouhy I, Paes RP, Barrese T, Vassallo J, Tarantino V, Vose J, Weisenburger D, Rudiger T, Federico M, Pileri S. Pitfalls and major issues in the histologic diagnosis of peripheral T-cell lymphomas: results of the central review of 573 cases from the T-Cell Project, an international, cooperative study. Hematol Oncol. 2017 Dec;35(4):630-636. doi: 10.1002/hon.2316. Epub 2016 Jun 3.
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BACKGROUND
Boddicker RL, Razidlo GL, Feldman AL. Genetic alterations affecting GTPases and T-cell receptor signaling in peripheral T-cell lymphomas. Small GTPases. 2019 Jan;10(1):33-39. doi: 10.1080/21541248.2016.1263718. Epub 2017 Jan 6.
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BACKGROUND
Haverkos BM, Huang Y, Gru A, Pancholi P, Freud AG, Mishra A, Ruppert AS, Baiocchi RA, Porcu P. Frequency and clinical correlates of elevated plasma Epstein-Barr virus DNA at diagnosis in peripheral T-cell lymphomas. Int J Cancer. 2017 Apr 15;140(8):1899-1906. doi: 10.1002/ijc.30566.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
T-Cell Project 2.0
Identifier Type: -
Identifier Source: org_study_id
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