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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients enrolled | Patient affected by sALCL (ALK positive and ALK negative) that have received BV-CHP as front-line therapy in real life setting |
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| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the progression free survival (PFS) | Progression free survival (PFS) from the diagnosis of ALCL | From the beginning to the end of the study (up to 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate overall response rate (metabolic CR+PR) | Rate of overall response rate (ORR, CR+PR) | From the beginning to the end of the study (up to 24 months) |
| To evaluate the overall survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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Patient affected by systemic Anaplastic Large Cell Lymphoma treated as front line therapy with BV-CHP in clinical practice
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Uffici Studi FIL | Contact | +390131033153 | startup@filinf.it | |
| Uffici Studi FIL | Contact | +390599769913 | gestionestudi@filinf.it |
| Name | Affiliation | Role |
|---|---|---|
| Carla Minoia, MD | Bari - I.R.C.C.S. Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.O.R.N. S. Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico | Avellino | Italy |
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| ID | Term |
|---|---|
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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Overall survival (OS) from diagnosis of lymphoma
| 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 | 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 | 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 | 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) | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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 | 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 | From the beginning to the end of the study (up to 24 months) |
| 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 |
|
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |