Clinical trial NCT03964480: Prospective Observational International Registry of Patients With Newly Diagnosed Peripheral T Cell Lymphoma.
Official title: Prospective Observational International Registry of Patients With Newly Diagnosed Peripheral T Cell Lymphoma.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral T-Cell Lymphoma
Keywords: Peripheral T-Cell Lymphoma
Prognosis
Outcome
Biological Characteristics
Heterogeneity
Rare Diseases
Lead sponsor: Associazione Angela Serra per la ricerca sul cancro
Sponsor class: OTHER
First posted: 2019-05-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Previously-untreated patients with de novo diagnosis of peripheral T-cell or NK/T-cell lymphoma:

Brief summary: 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.

Detailed description: Peripheral T-cell non-Hodgkin lymphomas (PTCLs) are a heterogeneous group of lymphoproliferative disorder arising from mature T cells of post-thymic origin at different stages of differentiation with different morphological patterns, phenotypes, and clinical presentation. All subtypes are found more commonly in male patients, and the median age at diagnosis is 62 years. This disease is generally associated with high relapse rates and a poor prognosis, with inferior treatment outcomes compared with B-cell lymphomas and have a 5-year-survival \< 32%.

T-cell lymphomas are widely recognized as a complex and heterogeneous group of lymphoproliferative disorders, generally associated with high relapse rates and a poor prognosis. Because of their rarity, they are still very poorly understood.

The introduction of new and more effective therapies and better technologies led the International T-cell non-Hodgkin's Lymphoma Study Group to launch the T-cell Project 2.0 in order to have a contemporary, real-time understanding of the T-cell lymphoma biology and treatment, together with the application of contemporary technologies to further identification of new therapeutic targets.

Per protocol, patients are evaluated according to the treating physician's standard practice. There are no specific evaluations or visits required for the Registry. Data captured in the Registry reflects what is routinely collected for patients with PTCL.

The study plans to collect the tissue sample for central review. The ordinary fixation, cryopreservation and routine tumor cytogenetics are planned for biopsy samples. Chairmen of the Histopathology Review Panel will locate Regional sites where expert hematopathologists will review the material and perform a panel of immunostains (T-cell panel + CD20) and markers not assessed at local site.

Adding of blood sample collection will allow estimating prospectively the frequency of pEBVd detection in our cohort of PTCL patients at baseline and at the end of initial therapy, to characterize agreement between pEBVd and EBER in tumor tissue, and to explore the prognostic or predictive implications of detectable pEBVd in PTCL. Finally, to investigate the genetics and pathogenic mechanisms of aggressive PTCLs on an international scale.

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.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 2 year
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 3 and 5 year
measure: Progression-Free Survival (PFS)
timeFrame: 3 and 5 years
measure: Event Free Survival (EFS)
timeFrame: at 24 months
measure: Complete Response Rate (CR)
timeFrame: at 30 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Bari
country: Italy
facility: IRCCS Istituto Tumori "Giovanni Paolo II"
city: Palermo
country: Italy
facility: Palermo_La Maddalena
city: Terni
country: Italy
facility: Terni-Santa Maria
city: Cluj Napoca
country: Romania
facility: Cluj Napoca_Ion Chiricuta Oncology Institute
city: Kiev
country: Ukraine
facility: National Cancer Institute
Study officials:
affiliation: University of Modena and Reggio Emilia, Centro Oncologico Modenese, Modena, Italy
name: Massimo Federico, MD
role: STUDY_DIRECTOR
affiliation: U.O. Ematologia, IRCCS Istituto Tumori "Giovanni Paolo II"
name: Attilio Guarini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Section of Hematology/Oncology, Nebraska Medical Center, USA
name: Julie Vose, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Memorial Sloan Kettering Cancer Center
name: Steven Horwitz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peter MacCallum Cancer Center, Melbourne, Australia
name: Miles Prince, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hematology-Oncology Samsung Medical Center, Seoul, South Korea
name: Kim Won Seog, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Biosanitaria de Salamanca, Salamanca, Spain
name: Dolores Caballero, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Sanitaria Universitaria Integrata S.M. Misericordia, Udine, Italy
name: Francesco Zaya, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: S.C. Ematologia, Arcispedale S. Maria Nuova-IRCCS, Reggio Emilia, Italy
name: Stefano Luminari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University Medical Center, Stanford, CA, USA
name: Ranjana Advani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seattle Cancer Care Alliance, Seattle, WA, USA
name: Andrei Shustov, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hematopoietic Stem Cell Transplantation, Sidney Kimmel Cancer Center, USA
name: Pierluigi Porcu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro de Hematologia, FUNDALEU, Buenos Aires, Argentina
name: Astrid Pavlovsky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Departamento de Clinica Médica, FCM da Santa Casa de Sao Paulo, Sao Paulo, Brazil
name: Carlos Chiattone, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University School of Medicine, New Haven, CT, USA
name: Francine Foss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Haematology, Nottingham University Hospitals NHS Trust, Nottingham, UK
name: Christopher Fox, MD
role: PRINCIPAL_INVESTIGATOR
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