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

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

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
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Associazione Angela Serra per la ricerca sul cancro (Academic / other)
• Locations: 6 sites (Stanford, California and 5 other locations)
• Trial ID: NCT03964480 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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

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

Eligibility 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 this trial is running

Stanford, California and 5 other locations

• Stanford University — Stanford, California, United States (Not_yet_recruiting)
• IRCCS Istituto Tumori "Giovanni Paolo II" — Bari, Italy (Recruiting)
• Palermo_La Maddalena — Palermo, Italy (Not_yet_recruiting)
• Terni-Santa Maria — Terni, Italy (Not_yet_recruiting)
• Cluj Napoca_Ion Chiricuta Oncology Institute — Cluj-Napoca, Romania (Recruiting)
• National Cancer Institute — Kiev, Ukraine (Recruiting)

Study contacts

• Principal investigator: Attilio Guarini, MD — U.O. Ematologia, IRCCS Istituto Tumori "Giovanni Paolo II"
• Study coordinator: Martina Manni, MSc, PhD

Conditions Peripheral T-Cell Lymphoma; Prognosis; Outcome; Biological Characteristics; Heterogeneity; Rare Diseases