Clinical trial Recruiting at 3 sites Observational Ages 18 and up

International registry for patients with newly diagnosed peripheral T-cell lymphoma

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

Run by Associazione Angela Serra per la ricerca sul cancro · NCT03964480 · Data updated 2026-11-12

This study is collecting information from people who have just been diagnosed with peripheral T-cell lymphoma to better understand the disease and improve treatment options.

More Peripheral T Cell Lymphoma trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment1000 (estimated)
SponsorAssociazione Angela Serra per la ricerca sul cancro
Academic / other
Locations6 sites (Stanford, California and 5 other locations)
StatusRecruiting
StartedOctober 14, 2018
Main results expectedJuly 30, 2025
Study endsJuly 30, 2025
Registry record updatedMay 6, 2025
Trial IDNCT03964480 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include previously untreated adults aged 18 and over with a de novo diagnosis of various subtypes of peripheral T-cell or NK/T-cell lymphoma.

Probably not a fit

Patients with previously treated peripheral T-cell lymphoma or those under 18 years old may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect data on patients with newly diagnosed peripheral T-cell lymphoma (PTCL) to improve understanding of the disease's prognosis and treatment strategies. It builds on previous research by the International T-cell Non-Hodgkin's Lymphoma Study Group and focuses on the clinical relevance of the new WHO Classification, the role of FDG-PET in staging, and the genomic landscape of different PTCL subtypes. The study will gather routine clinical data and tissue samples to enhance knowledge of PTCL biology and identify potential therapeutic targets.

Why it matters

Potential benefit: If successful, this study could lead to improved prognostic assessments and treatment strategies for patients with peripheral T-cell lymphoma.

How similar studies have gone: Other studies have shown success in similar approaches, but this study aims to provide a contemporary understanding of PTCL, making it a significant advancement.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

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.

Where it's running

  • IRCCS Istituto Tumori "Giovanni Paolo II"
    Bari, Italy
    Recruiting
  • Cluj Napoca_Ion Chiricuta Oncology Institute
    Cluj-Napoca, Romania
    Recruiting
  • National Cancer Institute
    Kiev, Ukraine
    Recruiting
  • Stanford University
    Stanford, California, United States
    Not yet recruiting
  • Palermo_La Maddalena
    Palermo, Italy
    Not yet recruiting
  • Terni-Santa Maria
    Terni, Italy
    Not yet recruiting

Study contacts

  • Principal investigator: Attilio Guarini, MD — U.O. Ematologia, IRCCS Istituto Tumori "Giovanni Paolo II"
  • Study coordinator: Martina Manni, MSc, PhD
  • Email: marmanni@unimore.it
  • Phone: +390594223284

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.