Clinical trial · Observational
Securing Access to Innovative Molecules in Oncology and Hematology for Children, Adolescents and Young Adults
NCT07727694CI-TRIAL-00119402(SACHA)recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| data collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients in therapeutic failure or relapse
- description
- Any child, adolescent or young adult, treated for a pediatric tumor or leukemia, in therapeutic failure or relapse without standard treatment option, not eligible / refusal of inclusion in a clinical study open on the territory and treated with an innovative drug within the framework of a compassionate use or outside marketing authorization, in one of the centers of the Belgian pediatric hemato-oncology centers
- interventionNames
- Other: data collection
Primary outcomes (2)
- measure
- Collect safety data
- timeFrame
- through study completion, an average of 1 year
- description
- 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.
- measure
- Collect activity data
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 25 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.