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

Официальное название

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

Обзор

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.

Первичные конечные точки

• To evaluate the progression free survival (PFS) [Срок оценки: From the beginning to the end of the study (up to 24 months)]

Вторичные конечные точки (12)

• To evaluate overall response rate (metabolic CR+PR) [Срок оценки: From the beginning to the end of the study (up to 24 months)]
• To evaluate the overall survival (OS) [Срок оценки: From the beginning to the end of the study (up to 24 months)]
• To evaluate safety profile of the BV-CHP regimen [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From the beginning to the end of the study (up to 24 months)]
• To assess the incidence of early and late relapses [Срок оценки: From the beginning to the end of the study (up to 24 months)]
• To assess the response rate to subsequent therapies including BV-retreatment [Срок оценки: From the beginning to the end of the study (up to 24 months)]
• To assess predictive factors of response rate [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From the beginning to the end of the study (up to 24 months)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 19 центров

• 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
• … и ещё 11 центров

Идентификаторы

NCT: NCT07467317 · FIL_BREAL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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