Back to search results

Observational Study for Newly Diagnosed Peripheral T-Cell Lymphoma

This is an international observational study, called T-Cell Project 2.0, for people newly diagnosed with peripheral T-cell lymphoma (PTCL) or NK/T-cell lymphoma. This study aims to gather information on how these rare and complex lymphomas behave and respond to treatment in real-time. Researchers hope to better understand the disease and identify new treatment targets. You can join if you are 18 or older and have a new diagnosis of certain types of T-cell or NK/T-cell lymphoma. The study will look at how long patients live without their disease getting worse (progression-free survival) over two years. This study is currently unclear about its recruitment status and plans to enroll about 1000 patients.

Study design
This is an international observational study that aims to collect data from approximately 1000 patients.
What's involved
Patients are evaluated according to their doctor's standard practice. There are no specific evaluations or visits required for this Registry.
Compensation
Not stated in the trial record.
Follow-up
The study measures progression-free survival at 2 years, suggesting a follow-up period of at least two years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03964480

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

Recruiting
Not specifiedAges 18+Observational
Associazione Angela Serra per la ricerca sul cancro
~1,000 participants
Updated 2025-05-06 on ClinicalTrials.gov

At a glance

Recruiting sites
3 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival (PFS)
Measured over 2 year

Conditions

Peripheral T-Cell Lymphoma

Explore related trials

Hematologic NeoplasmMature T-Cell and NK-Cell Non-Hodgkin LymphomaT-Cell Non-Hodgkin Lymphoma

NCT03964480

Where you'd take part

This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cluj Napoca_Ion Chiricuta Oncology Institute

    Cluj-Napoca, Romaniastudy coordinator listed

    Recruiting

  • IRCCS Istituto Tumori "Giovanni Paolo II"

    Bari, Italystudy coordinator listed

    Recruiting

  • National Cancer Institute

    Kiev, Ukrainestudy coordinator listed

    Recruiting

  • Palermo_La Maddalena

    Palermo, Italystudy coordinator listed

    Not yet recruiting

  • Stanford University

    Stanford, Californiastudy coordinator listed

    Not yet recruiting

  • Terni-Santa Maria

    Terni, Italystudy coordinator listed

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • 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

Who to contact

Martina Manni, MSc, PhD
[email protected]
+390594223284
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Progression-free survival (PFS)2 year

    Measured from the date of diagnosis until the date of disease progression or death from T-cell Lymphoma