BV-CHP Real-life and Biological Evidences in Patients With sALCL (FIL_BREAL)

Fondazione Italiana Linfomi - ETS

Status: Not yet enrolling

Conditions: Anaplastic Large Cell Lymphoma

Study type: Observational

Funder types: Other

Identifiers

NCT07467317

FIL_BREAL

Details and patient eligibility

About

Systemic Anaplastic Large Cell Lymphomas (sALCL) are rare lymphomas for which the cooperation in the collection of biological and clinical data is necessary to improve knowledge on the disease. The addition of a targeted therapy to chemotherapy recently showed to be effective compared to standard chemotherapy. First-line therapy brentuximab vedotin-CHP for sALCL was recently approved in Italy following the published 5-year data from the ECHELON-2 study. Correlations with biological parameters are missing.

Within the framework of the FIL, Investigators will assess the clinical outcomes-specifically response rates, progression-free survival (PFS), safety-in a retrospective cohort of patients diagnosed with sALCL and treated frontline with BV-CHP in the real-life setting. These outcomes will be correlated with data derived from PET/CT imaging and lymph node biological samples.

Furthermore, Investigators will collect lymph node samples of patients diagnosed with sALCL and treated with BV-CHP at FIL Centers. The study will investigate the prognostic relevance of known molecular alterations (e.g., DUSP22, TP63). Through whole-exome sequencing and transcriptomic profiling, recurrent genetic alterations will be explored, as well as the cell of origin and the tumor microenvironment of sALCL, with particular attention to cell-to-cell interactions. A machine learning model will be validated to identify DUSP22 rearrangements from hematoxylin&eosin (H&E)-stained slides. Finally, integrated analysis of omics and clinical data using AI will aim to uncover biological signatures predictive of treatment response.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years;
• Histological diagnosis of sALCL (ALK positive and ALK negative);
• Have received BV-CHP as front-line therapy in real life setting;
• Availability of histological material of initial ALCLs diagnosis: a FFPE block from an excisional/incisional biopsy must be provided for patient enrollment. FNAB and GNAB will not be considered for the study;
• Signed written informed consent

Exclusion criteria

• Histological diagnosis other than sALCL;
• Front line treatment other than BV-CHP;
• Patients treated with BV-CHP in the contest of a clinical trial;
• Refuse to sign a written informed consent.

Trial design

100 participants in 1 patient group

Patients enrolled

Description:

Patient affected by sALCL (ALK positive and ALK negative) that have received BV-CHP as front-line therapy in real life setting