Securing Access to Innovative Molecules in Oncology and Hematology for Children, Adolescents and Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,600
- 试验地点
- 6
- 主要终点
- Collect safety data
研究概览
简要总结
It involves collecting safety and efficacy data, under the actual conditions of use of off label and compassionate use medicines in children and adolescents approved in humans before 2007, using a validated tool (Ennov EDC) and relying on the network recognised pediatric hemato-oncology centers in Belgium and responsible for the organization of Pediatric National tumor boards which discuss each case of relapse in order to define the best therapeutic options.
详细描述
The objective is to aim for completeness throughout the national territory. This is why this project will be carried out in close collaboration with all recognised pediatric hemato-oncology centers in Belgium.
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
- 0 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≤ 25 at the time of inclusion in the study
- •Patient with a pediatric malignancy (solid tumor or leukemia), or other related condition
- •Patient not currently enrolled on any other trial for ongoing therapeutic purposes
- •Patient treated with compassionate use of experimental drugs or off-label administration use of anti-cancer medicines first approved in adults after 2007 in Europe
- •Patient discussed in a Pediatric multidisciplinary tumor boards (MDTB) to validate the inclusion in the SACHA study
- •Consent to participate by the patient or his/her legal representatives in the study if required by ta particular national jurisdiction
排除标准
- •Patient receiving the drug within a clinical trial.
- •Oral refusal to participate to the study, by the patient or his/her parents/legal representatives.
结局指标
主要结局
Collect safety data
时间窗: through study completion, an average of 1 year
From patients receiving innovative molecules outside a clinical trial (targeted therapies, immunotherapies or chemotherapies off label or compasionate use approved in adults as of 2007), safety data will be collected. Adverse events will be collected through the CTCAE version N°5.
Collect activity data
时间窗: through study completion, an average of 1 year
From patients receiving innovative molecules outside a clinical trial (targeted therapies, immunotherapies or chemotherapies off label or compasionate use approved in adults as of 2007), the response to the treatment (complete response, partial response, stable disease, progression) will be collected.
次要结局
未报告次要终点