Non-interventional, Prospective Observational Study of the Treatment Practice of CNS Involvement of Malignant Lymphoma in Routine Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Outcome of different therapeutic regimens
研究概览
简要总结
The objective of the observation is to collect and document data on treatment strategies for secondary central nervous system lymphoma (SCNSL) in routine clinical practice, whether obtained in the context of clinical trials or outside of trials. In particular, the following questions will be specified:
- What therapeutic approaches are being pursued?
- What is the clinical outcome of the various treatment options?
- What is the frequency of serious adverse events with each therapeutic approach?
详细描述
The observational study is to be conducted in inpatient clinics, outpatient clinics and by oncology physicians in private practice. The investigators will be invited to participate by the Charité - CNS Lymphoma Working Group (Charité AG ZNSL) or the Competence Network Malignant Lymphomas (KML). When a patient is reported, the personal data of the physician including the patient will be recorded and compiled in the form of a list documentation.
All patients with SCNSL can and should be included in the study regardless of which therapy options are used and regardless of whether it is a first-line treatment, the treatment of a recurrence or a maintenance therapy for SCNSL. No intervention is associated with the conduct of the observational study with regard to the selection and implementation of the specific therapeutic regimen, diagnostics, and examination frequency during and after treatment.
The following information should be documented:
- Patient demographics and medical history
- Tumor extent at the time of initial diagnosis and CNS involvement
- Prior therapy
- General condition
- Therapy regimen for the CNS involvement
- Response
- Adverse drug reactions
- Tolerability of therapy: acute toxicity
- Chronic therapy toxicity, especially late neurotoxicity
- Time to treatment failure (relapse or progression)
- Death from any cause
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with SCNSL can and should be included in the registry regardless of which treatment options are used and whether the treatment being given is first-line, recurrence, or maintenance therapy for SCNSL.
排除标准
- 未提供
结局指标
主要结局
Outcome of different therapeutic regimens
时间窗: Through study completion, an average of 3 years
Progression Free Survival
Description of different therapeutic regimens
时间窗: Through study completion, an average of 3 years
Description of different therapeutic regimens
次要结局
未报告次要终点
研究者
Stefan Habringer
Principal Investigator
Charite University, Berlin, Germany
