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

Starting soon

Conditions studied: Anaplastic Large Cell Lymphoma

In brief

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.

Key facts

Study ID

NCT07467317

Run by

Fondazione Italiana Linfomi - ETS

People needed

100

Starts

2026-05-01

Expected to finish

2028-05-01

Last updated by the study team

2026-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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

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