Collecting safety and results data on off-label cancer medicines in young people
Gathers safety and effectiveness data on off-label medicines in children and young adults with cancer.
Plain-language title generated from the registry record
Registry title: Securing Access to Innovative Molecules in Oncology and Hematology for Children, Adolescents and Young Adults
Key facts
- Where
- Antwerp, Brussels, Ghent, Leuven, and Liège, BelgiumSee the 6 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 0 and 25 years old?
Source: NCT07727694, who can take part
Where in Belgium
- University Hospital, AntwerpAntwerp, BelgiumNot yet recruiting
- Cliniques universitaires Saint-LucBrussels, BelgiumNot yet recruiting
- Hôpital Universitaire des Enfants Reine Fabiola (Huderf)Brussels, BelgiumNot yet recruiting
- University Hospital GentGhent, BelgiumNot yet recruiting
- University Hospital LeuvenLeuven, BelgiumTaking people
- CHC MontLégiaLiège, BelgiumNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universitaire Ziekenhuizen KU Leuven
- Trial code
- NCT07727694
- Record updated
- 27 July 2026
- Original description
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.Read full original descriptionShow less
Securing Access to Innovative Molecules in Oncology and Hematology for Children, Adolescents and Young Adults
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.
Inclusion: 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.
Exclusion: Patient receiving the drug within a clinical trial; Oral refusal to participate to the study, by the patient or his/her parents/legal representatives.