DLBCL Interim Response Evaluation for Customised Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Successful identification of trackable mutations in collected samples. Feasibility will be met if more than 75% of the samples yield trackable mutations across the whole study.
研究概览
简要总结
The aim of the DIRECT Study is to establish a robust pipeline to identify those patients with high-grade B cell lymphoma most suitable for novel agent clinical trials based upon genomic subtype and an integrated response evaluation determined early in first-line therapy.
详细描述
This will be done by integrating data and samples collected from patients undergoing standard of care treatment for high-grade B cell lymphoma
Data will be integrated from
- Clinical risk factors from the International Prognostic Index (IPI)
- Up-front genomic subtype based on molecular profiling of diagnostic biopsy
- Serial ctDNA monitoring during treatment.
- Radiological response imaging
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 未提供
排除标准
- •Unable to receive immunochemotherapy as first-line therapy due to co-morbidity or personal choice.
- •Patients who have already started high dose steroids as a treatment for their lymphoma.
- •Known diagnosis of infectious blood-borne virus e.g. Hep B, Hep C or HIV.
结局指标
主要结局
Successful identification of trackable mutations in collected samples. Feasibility will be met if more than 75% of the samples yield trackable mutations across the whole study.
时间窗: 3-5 years
Establish a robust molecular monitoring pipeline.
时间窗: 3-5 years
次要结局
- Assess the utility of integrated data from clinical risk factors (IPI), up-front genotype, serial ctDNA response and radiological assessment (CT or PET-CT).(3-5 years)
- Assess the utility of serial ctDNA assessment as a predicator of clinical outcome in high-grade B cell lymphoma.(5 years)
- When the pipeline is optimised can these 4 parameters be available within 6 weeks, i.e. by completion of Cycle 2.(3-5 years)
研究者
Daniel Hodson
Dr
Cambridge University Hospitals NHS Foundation Trust