BV-CHP Real-life and Biological Evidences in Patients With sALCL
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Anaplastic Large Cell Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
FIL_BREAL: BV-CHP Real-life and Biological Evidences in Patients With sALCL
Overview
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.
Primary outcome measures
- To evaluate the progression free survival (PFS) [Time frame: From the beginning to the end of the study (up to 24 months)]
Secondary outcome measures (12)
- To evaluate overall response rate (metabolic CR+PR) [Time frame: From the beginning to the end of the study (up to 24 months)]
- To evaluate the overall survival (OS) [Time frame: From the beginning to the end of the study (up to 24 months)]
- To evaluate safety profile of the BV-CHP regimen [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 [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 [Time frame: From the beginning to the end of the study (up to 24 months)]
- To assess the incidence of early and late relapses [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 [Time frame: From the beginning to the end of the study (up to 24 months)]
- To assess predictive factors of response rate [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 [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 [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 [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 [Time frame: From the beginning to the end of the study (up to 24 months)]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 19 centers
- A.O.R.N. S. Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico — Avellino
- I.R.C.C.S. Centro di Riferimento Oncologico - S.O.C. Oncologia medica e dei tumori immuno- — Aviano
- I.R.C.C.S. Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia — Bari
- A.S.S.T Papa Giovanni XXIII - S.C. Ematologia — Bergamo
- I.R.C.C.S. A.O.U. di Bologna Policlinico S. Orsola - U.O. Ematologia — Bologna
- I.R.C.C.S. Istituto di Candiolo - FPO — Candiolo
- A.S.S.T. Ovest Milanese Ospedale di Legnano - U.O.C. di Ematologia — Legnano
- A.S.S.T. Grande Ospedale Metropolitano Niguarda - S.C. Ematologia — Milan
- … and 11 more centers
Identifiers
NCT: NCT07467317 · FIL_BREAL