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

Condition(s) studied

Investigational drug(s) / intervention(s)

Data collection: In particular, the patient's demographic data, medical history, previous and concomitant treatments, data on the treatment of interest (legal framework, compassionate use/ off-label), dosage, start date, etc.), clinical data will be collected. biological (including molecular profiling of the tumor if available) and radiological follow-up, information on adverse effects. The data to be filled in is that of the CERFA pharmacovigilance form of the ANSM, but additional fields can be created if necessary.

Study summary

It involves collecting safety and efficacy data, under the actual conditions of use of medicines in children and adolescents, using a validated tool (Ennov EDC) and relying on the network of Interregional pediatric oncology appeal organizations (RIOs) identified by INCa since 2010 and responsible for the organization of Pluridisciplinary Pediatric Interregional (RCPPI) and National Consultative Meetings which discuss each case of relapse in order to define the best therapeutic options.

Eligibility

Primary outcome measure(s)

• Collect access data — From enrollment to the end of treatment maximum 7 years
  Collect access data of children, adolescents and young adults in therapeutic failures and not eligible for a clinical trial with innovative molecules, whether they are targeted therapies, immunotherapies or chemotherapies

Trial sites (32)

More Gustave Roussy, Cancer Campus, Grand Paris trials in France

Other trials for the same condition