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.
Study Type
OBSERVATIONAL
Enrollment
100
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
...and 9 more locations
To evaluate the progression free survival (PFS)
Progression free survival (PFS) from the diagnosis of ALCL
Time frame: From the beginning to the end of the study (up to 24 months)
To evaluate overall response rate (metabolic CR+PR)
Rate of overall response rate (ORR, CR+PR)
Time frame: From the beginning to the end of the study (up to 24 months)
To evaluate the overall survival (OS)
Overall survival (OS) from diagnosis of lymphoma
Time frame: From the beginning to the end of the study (up to 24 months)
To evaluate safety profile of the BV-CHP regimen
Incidence of any grade of adverse events (AEs) and of AEs with grade \>2 according to CTCAE v5
Time frame: From the beginning to the end of the study (up to 24 months)
To assess the prognostic role of interim PET scan in term of Progression Free Survival
PFS stratified according to interim PET result
Time frame: From the beginning to the end of the study (up to 24 months)
To explore the role of ASCT consolidation in term of overall response rate
Rate of ORR and CR with and without ASCT consolidation
Time frame: From the beginning to the end of the study (up to 24 months)
To assess the incidence of early and late relapses
Rate of POD24 (early and late first progression/relapse after induction treatment)
Time frame: From the beginning to the end of the study (up to 24 months)
To assess the response rate to subsequent therapies including BV-retreatment
Rate of CR and ORR after subsequent therapies
Time frame: From the beginning to the end of the study (up to 24 months)
To assess predictive factors of response rate
Investigate if one or more response rate predictive factors could be identify among clinical data, biological data (presence of ALK, DUSP22, TP63 alterations, mutational landscape, gene expression profile, immunological characteristics, tumor microenvironment features) and imaging data (PET scan results, baseline TMTV and TLG values)
Time frame: From the beginning to the end of the study (up to 24 months)
To assess the prognostic role of interim PET scan in term of Overall Survival
OS stratified according to interim PET result
Time frame: From the beginning to the end of the study (up to 24 months)
To assess the prognostic role of end of treatment PET scan in term of Overall Survival
OS stratified according to EOT PET result
Time frame: From the beginning to the end of the study (up to 24 months)
To assess the prognostic role of end of treatment PET scan in term of Progression Free Survival
PFS stratified according to EOT PET result
Time frame: From the beginning to the end of the study (up to 24 months)
To assess the prognostic role of baseline Total Metabolic Tumor Volume in term of Overall Survival
OS stratified according to baseline PET TMTV
Time frame: From the beginning to the end of the study (up to 24 months)
To assess the prognostic role of baseline Total Metabolic Tumor Volume in term of Progression Free Survival
PFS stratified according to baseline PET TMTV
Time frame: From the beginning to the end of the study (up to 24 months)
To assess the prognostic role of baseline Total Lesion Glycolysis in term of Overall Survival
OS stratified according to baseline PET TLG
Time frame: From the beginning to the end of the study (up to 24 months)
To assess the prognostic role of baseline Total Lesion Glycolysis in term of Progression Free Survival
PFS stratified according to baseline PET TLG
Time frame: From the beginning to the end of the study (up to 24 months)
To assess predictive factors of Progression Free Survival
Investigate if one or more PFS predictive factors could be identify among clinical data, biological data (presence of ALK, DUSP22, TP63 alterations, mutational landscape, gene expression profile, immunological characteristics, tumor microenvironment features) and imaging data (PET scan results, baseline TMTV and TLG values)
Time frame: From the beginning to the end of the study (up to 24 months)
To assess predictive factors of Overall Survival
Investigate if one or more OS predictive factors could be identify among clinical data, biological data (presence of ALK, DUSP22, TP63 alterations, mutational landscape, gene expression profile, immunological characteristics, tumor microenvironment features) and imaging data (PET scan results, baseline TMTV and TLG values)
Time frame: From the beginning to the end of the study (up to 24 months)
To explore the role of ASCT consolidation in term of Progression Free Survival
PFS stratified with and without ASCT consolidation
Time frame: From the beginning to the end of the study (up to 24 months)
To explore the role of ASCT consolidation in term of Overall Survival
OS stratified with and without ASCT consolidation
Time frame: From the beginning to the end of the study (up to 24 months)
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