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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Associazione Angela Serra per la ricerca sul cancro Academic / other |
| Locations | 6 sites (Stanford, California and 5 other locations) |
| Status | Recruiting |
| Started | October 14, 2018 |
| Main results expected | July 30, 2025 |
| Study ends | July 30, 2025 |
| Registry record updated | May 6, 2025 |
| Trial ID | NCT03964480 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.
-
Non-Hodgkin Lymphoma Sample Collection for MRD Testing
This study tests a blood-based and tissue-based approach to see if a molecular residual disease test can detect lingering cancer in adults with aggressive NHL who are starting standard therapy.
-
XNW5004 with CHOP/CHOEP in Untreated Peripheral T-Cell Lymphoma
This study tests XNW5004 together with CHOP or CHOEP in adults with newly diagnosed peripheral T-cell lymphoma to see if the combination is safe and active.
-
Adaptive dual-target CAR-T therapy for relapsed or refractory blood cancers
This trial will test whether matching a patient's cancer markers to one of several dual-target CAR-T therapies can work and be safe for adults whose blood cancer has come back or not responded.
-
Treatment options for peripheral T‑cell lymphoma after no response to first‑line therapy
This project will try allogeneic stem cell transplant versus other salvage treatments for adults with peripheral T‑cell lymphoma who did not respond to first‑line chemotherapy.
-
Golidocitinib versus placebo as maintenance treatment for PTCL patients in remission after first-line chemotherapy
This trial tests whether taking golidocitinib every other day can help keep peripheral T‑cell lymphoma from coming back in adults who responded to first‑line chemotherapy but cannot have a stem cell transplant.
-
Cidabenamine plus azacitidine to prevent post-transplant progression in high-risk peripheral T‑cell lymphoma
This trial will test whether adding cidabenamine to azacitidine after allogeneic stem cell transplant can help prevent progression in adults with high‑risk peripheral T‑cell lymphoma.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.