Molecular Mechanisms in Malignant Lymphoma- Predict
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS-2) with 95% confidence intervals
研究概览
简要总结
The trial aims at the construction and validation of an accurate, affordable and simple prognostic tool to be used in everyday clinical practice, which allows the early and reliable identification of DLBCL patients who have a very high risk of treatment failure following R-CHOP/-like first-line therapy.
详细描述
Observational study of 500 recruited and 300 evaluable patients with de novo large cell B Cell lymphoma, age 18-80. Standard guideline recommended treatment by treating physicians discretion. Collection of clinical data, PET-CT data, liquid biopsy, WGSequencing to determine optimal prognostic factors to surpass prediction offered by current IPI.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of DLBCL&LBCL
- •Planned treatment with guideline-based first-line therapy
- •Patient's consent
- •All genders, Patient age ≥ 18 years
- •Ability to consent
排除标准
- •Treatment with R-CHOP/-like regimens already started
- •Relationship of dependence/ direct employment with the investigator
- •Active HIV-infection
- •Presence history of other active cancers (with the exception of basal cell carcinoma of the skin)
结局指标
主要结局
Progression-free Survival (PFS-2) with 95% confidence intervals
时间窗: 2 years
PFS is defined as the time from the day of inclusion into the observation trial through one of the following events, whichever comes first: * Change of treatment due to response in iPET (PD - Progressive Disease) * Disease progression * Relapse * Death due to any cause Patients without event at the time of analysis will be censored at the most recent date of disease assessment.
次要结局
- Overall Survival (OS)(5 years)
- Event-free survival (EFS)(5 years)
- Safety and toxicity(5 years)
- Response rates(2 years)
研究者
Trümper
Prof. Dr. Lorenz Trümper
University Medical Center Goettingen