NCT03964480 · Associazione Angela Serra per la ricerca sul cancro
Prospective Observational International Registry of Patients With Newly Diagnosed Peripheral T Cell Lymphoma.
What this study is about
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: forward-looking Collection of Data in Patients With Peripheral T-Cell Lymphoma) as a forward-looking collection of data to predict the prognosis of patients with the more frequent subtypes of PTCL.
View original scientific description
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.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- 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.
Exclusion criteria
- 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
Where
- Stanford, California
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 6, 2025 · Source of record for eligibility and locations