NCT03104478已完成不适用
Real Time Molecular Characterization of Diffuse Large B Cell Lymphoma (DLBCL)
The Lymphoma Academic Research Organisation15 个研究点 分布在 1 个国家目标入组 219 人开始时间: 2017年5月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 219
- 试验地点
- 15
- 主要终点
- Real time report of molecular characterization
研究概览
简要总结
The trial will enroll 194 previously untreated DLBCL patients over 20 months, with the objective to send to the local investigator an extensive molecular tumor characterization by D38 in at least 80% of enrolled patients.
The feasibility and efficiency will be demonstrated by deploying and operating a nation-wide network of dedicated multidisciplinary platforms.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •DLBCL patients that will be eligible in front-line treatment for a combination of anthracycline-based chemotherapy plus anti-CD20 monoclonal antibody,Rituximab: R-CHOP 14, R-CHOP 21, R mini-CHOP, R-ACVBP, R-COPADEM. Patients treated with R-CHOP associated with an experimental drug ((polatuzumab, tazemetostat, venetoclax, entospletinib, lenalidomide, ibrutinib, anti PD1/anti PDL1 ....)
- •A short corticotherapy (prednisone, maximum 7 days) given during pre-phase therapy is allowed.
- •Eligible histological subtypes: in particular DLBCL NOS, PMBL, high grade B-cell lymphoma (HGBCL) withMYC and BCL2 and/or BCL6 rearrangements, HGBCL NOSFL grade 3B and untreated transformed low grade NHL.
- •≥ 18 years old, IPI = 0-5
- •With available tumor Biopsy (FFPE) that can be sent to RT3 platform at the time of inclusion (or the say after inclusion at the latest).
- •Patient that underwent needle core biopsy samples are not excluded if sufficient material is available for molecular and histopathological explorations
排除标准
- •No available FFPE biopsy material or insufficient quality/quantity tumor samples according to prerequisite
- •No signed informed consent
结局指标
主要结局
Real time report of molecular characterization
时间窗: 38 days (i.e. 38 days after starting inductive chemotherapy regimen
To timely report the molecular characterization (pathogenic, diagnostic, prognostic, theranostic markers) of previously untreated DLBCL patients prior to day 38(i.e. 38 days after starting inductive chemotherapy regimen, in at least 80% of enrolled patients
次要结局
未报告次要终点
研究者
研究点 (15)
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