Securing Access to Innovative Molecules in Oncology and Hematology for Children, Adolescents and Young Adults

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-25
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Patient receiving the drug within a clinical trial.

Oral refusal to participate to the study, by the patient or his/her parents/legal representatives.

Trial design

Treatments tested in this trial

  • data collection

Treatment groups

1,600 Participants
are divided into 1 treatment group