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.
| Facility | City | Region | Status |
|---|---|---|---|
| A.O.R.N. S. Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico | Avellino | Italy | |
| I.R.C.C.S. Centro di Riferimento Oncologico - S.O.C. Oncologia medica e dei tumori immuno-correlati | Aviano | Italy | |
| I.R.C.C.S. Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia | Bari | Italy | |
| A.S.S.T Papa Giovanni XXIII - S.C. Ematologia | Bergamo | Italy | |
| I.R.C.C.S. A.O.U. di Bologna Policlinico S. Orsola - U.O. Ematologia | Bologna | Italy | |
| I.R.C.C.S. Istituto di Candiolo - FPO | Candiolo | Italy | |
| A.S.S.T. Ovest Milanese Ospedale di Legnano - U.O.C. di Ematologia | Legnano | Italy | |
| A.S.S.T. Grande Ospedale Metropolitano Niguarda - S.C. Ematologia | Milan | Italy | |
| I.R.C.C.S. Istituto Europeo di Oncologia - U.O. Oncoematologia | Milan | Italy | |
| I.R.C.C.S. Ospedale San Raffaele - U.O. Ematologia e Trapianto di Midollo Osseo | Milan | Italy | |
| A.S.L. di Pescara P.O. Santo Spirito - U.O.C. Ematologia | Pescara | Italy | |
| A.U.S.L. di Piacenza Osp. Guglielmo da Saliceto - U.O.C. Ematologia e Centro Trapianti | Piacenza | Italy | |
| I.R.C.C.S. Fondazione Policlinico Universitario Gemelli - U.O.S.D. Malattie linfoproliferative extramidollari | Roma | Italy | |
| IRCCS Humanitas Research Hospital - U.O. Ematologia | Rozzano | Italy | |
| A.O. Ordine Mauriziano - S.C.D.U. Ematologia | Torino | Italy | |
| A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia | Torino | Italy | |
| U.L.S.S. 2 Marca Trevigiana Osp. Ca' Foncello - U.O.C. Ematologia | Treviso | Italy | |
| A.S.S.T. Sette Laghi - S.C. Ematologia | Varese | Italy | |
| U.L.S.S. 8 Berica - U.O.C. Ematologia | Vicenza | Italy |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07467317 on ClinicalTrials.gov ↗ ← All trials in Italy