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

Summary

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

Inclusion Criteria:

* 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 Criteria:

* Patient receiving the drug within a clinical trial.
* Oral refusal to participate to the study, by the patient or his/her parents/legal representatives.

Conditions2

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