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

Peripheral T-Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03964480
• Other study ID #: T-Cell Project 2.0
• Status: Recruiting
• Start date: October 14, 2018
• Est. completion date: July 30, 2025

Study information

• Verified date: July 2020
• Source: Associazione Angela Serra per la ricerca sul cancro
• Contact: Martina Manni, MSc, PhD
• Phone: +390594223284
• Email: marmanni[@]unimore.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: July 30, 2025
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T-Cell Lymphoma

Locations

Country	Name	City	State
Italy	IRCCS Istituto Tumori "Giovanni Paolo II"	Bari
Italy	Palermo_La Maddalena	Palermo
Italy	Terni-Santa Maria	Terni
Romania	Cluj Napoca_Ion Chiricuta Oncology Institute	Cluj Napoca
Ukraine	National Cancer Institute	Kiev
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Associazione Angela Serra per la ricerca sul cancro

Countries where clinical trial is conducted

United States,  Italy,  Romania,  Ukraine, 

References & Publications (46)

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* Note: There are 46 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)	Measured from the date of diagnosis until the date of disease progression or death from T-cell Lymphoma	2 year
Secondary	Overall Survival (OS)	Measured from the date of diagnosis until death from any cause	3 and 5 year
Secondary	Progression-Free Survival (PFS)	Measured from the date of diagnosis until the date of disease progression or death from T-cell Lymphoma	3 and 5 years
Secondary	Event Free Survival (EFS)	Measured from the date of diagnosis until the date of event	at 24 months
Secondary	Complete Response Rate (CR)	Complete response rate at 30 months (CR30) after enrollment (i.e., initiation of treatment)	at 30 months

External Links

•   Bellei M, Foss F, Horwitz S, et al: The Outcome of Patients with Primary Refractory or Relapsed Peripheral T-Cell Lymphoma: Analysis of 1020 Cases Registered in the Prospective T-Cell Project. Blood 128:921, 2016
•   Foss F, Horwitz S, Bellei M, et al: Outcome of Patients with Gamma Delta T Cell Lymphomas: Analysis of 1429 Cases Registered in the Prospective T-Cell Project. Blood 130:1512, 2017
•   Fox C, Bellei M, Manni M, et al: Improved survival outcomes for patients with extra-nodal nk/t lymphoma: data from 140 patients prospectively registered in the international T-cell project. Hematol Oncol 35:1-466, 2017
•   Pileri S, Federico M, Fossa F, et al: Pooled analysis of biomarker data quality from the Tcell project and complete studies. Hematol Oncol 31 (Suppl.:201-270, 2013
•   Shustov AR, Bellei M, et al.: Clinical Outcomes of Patients with Anaplastic Large Cell Lymphoma, Anaplastic Lymphoma Kinase-Positive (ALCL, ALK+): Data from 119 Patients Prospectively Registered in the International T-Cell Project. Blood 130:4072, 2017
•   Shustov AR, Cabrera ME, Bellei M, et al: Clinical Outcomes of Patients with Anaplastic Large Cell Lymphoma, Anaplastic Lymphoma Kinase-Negative (ALCL, ALK-): Analysis of 203 Patients Prospectively Registered in the International T-Cell Project.