Primary Mediastinal Large B-cell Lymphoma (PMBCL): Multicenter Retrospective Study by the Fondazione Italiana Linfomi.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 633
- 试验地点
- 80
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
The present study consists of a retrospective multicentric collection of all consecutive patients with PMBCL diagnosed over the time period considered (13 years, from 2007 to 2019 inclusive).
详细描述
The study was initially set up as a spontaneous, non-profit study, with ARNAS Garibaldi of Catania (PI Dr Ugo Consoli) as the proposer. Subsequently, the project was expanded to include additional centres belonging to the Italian Lymphoma Foundation, which became the promoter in collaboration with ARNAS Garibaldi of Catania. The information collected is aimed at verifying the application in a "real world" context of the PMBCL diagnosis and therapy protocols suggested in the guidelines and at checking whether they produce results in line with those expected.
The therapies considered for the I line of treatment are those described in the literature for the pathology under consideration:
- R-CHOP14; R-CHOP21 and R-CHOP like, (R-CHOP: rituximab - cyclophosphamide, doxorubicin, vincristine, prednisone)
- R-VACOPB, R-MACOPB and R-VACOPB like, MACOPB like, (R-VACOP-B: Rituximab - etoposide, doxorubicin, cyclophosphamide, vincristine, prednisone, bleomycin. R-MACOP-B: Rituximab - methotrexate, doxorubicin, cyclophosphamide, vincristine, prednisone, bleomycin)
- R-DA-EPOCH ed R-EPOCH like (DA-R- EPOCH: Dose Adjusted - Rituximab - Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin)
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
- •All consecutive patients treated in the centre during the period considered
- •Age>=18 years
- •Histological diagnosis of PMBCL
- •Signature of "Informed Consent" to participate in the study (if applicable)
- •Treatment according to local practice
- •Diagnosis between 01 January 2007 and 31 December 2019
排除标准
- •- The exclusion criteria, being an observational study, are focused and limited to excluding cases with a non-compliant histological diagnosis.
结局指标
主要结局
Overall response rate (ORR)
时间窗: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
Overall Response Rate is defined as the percentage of patients in complete remission or in partial remission
Frequency of administration of mediastinal radiation therapy
时间窗: four months after completion of chemotherapy
Analyze the frequency of administration of mediastinal radiation therapy in patients affected by primary mediastinal large B-cell lymphoma
Overall Survival (OS)
时间窗: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
Overall Survival, the percentage of patients alive, is defined from the start date of therapy to the date of death from any cause.
Progression Free Survival (PFS)
时间窗: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
The length of time during and after the treatment that patients live with the disease, but it does not get worse. Progression-Free Survival (PFS) will be defined from the date of starting therapy and the date of disease progression, relapse or death from any cause.
Rate of primary/early refractory disease
时间窗: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
The study aims to evaluate the rate of primary/early refractory disease (Primary mediastinal large B-cell lymphoma)
Complete response rate (CRR)
时间窗: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
The Complete Response Rate is defined as the percentage of patient in Complete Remission
次要结局
- Acute toxicity(The endpoint will be evaluated from the beginning to the end of the study (up to 24 months))
- Long-term toxicity(The endpoint will be evaluated from the beginning to the end of the study (up to 24 months))