FIL_BREAL: BV-CHP Real-life and Biological Evidences in Patients With sALCL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 19
- 主要终点
- To evaluate the progression free survival (PFS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Patients enrolled
Patient affected by sALCL (ALK positive and ALK negative) that have received BV-CHP as front-line therapy in real life setting
结局指标
主要结局
To evaluate the progression free survival (PFS)
时间窗: From the beginning to the end of the study (up to 24 months)
Progression free survival (PFS) from the diagnosis of ALCL
次要结局
- To evaluate overall response rate (metabolic CR+PR)(From the beginning to the end of the study (up to 24 months))
- To evaluate the overall survival (OS)(From the beginning to the end of the study (up to 24 months))
- To evaluate safety profile of the BV-CHP regimen(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(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(From the beginning to the end of the study (up to 24 months))
- To assess the incidence of early and late relapses(From the beginning to the end of the study (up to 24 months))
- To assess the response rate to subsequent therapies including BV-retreatment(From the beginning to the end of the study (up to 24 months))
- To assess predictive factors of response rate(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(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(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(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(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(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(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(From the beginning to the end of the study (up to 24 months))
- To assess predictive factors of Progression Free Survival(From the beginning to the end of the study (up to 24 months))
- To assess predictive factors of Overall Survival(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(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(From the beginning to the end of the study (up to 24 months))