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NOT YET RECRUITING
NCT07467317

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

Sponsor: Fondazione Italiana Linfomi - ETS

View on ClinicalTrials.gov

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

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