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BV-CHP Real-life and Biological Evidences in Patients With sALCL
Sponsor: Fondazione Italiana Linfomi - ETS
Summary
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.
Official title: FIL_BREAL: BV-CHP Real-life and Biological Evidences in Patients With sALCL
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2026-05
Completion Date
2028-05
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Locations (19)
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