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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Pediatric Cancer Neoplasms

Age range

0 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Antwerp, Antwerp, Belgium

About this study

The objective is to aim for completeness throughout the national territory. This is why this project will be carried out in close collaboration with all recognised pediatric hemato-oncology centers in Belgium.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data Collection

Other

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.

Primary outcomes

Collect safety data

Time frame: through study completion, an average of 1 year

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.
Collect activity data

Time frame: through study completion, an average of 1 year

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), the response to the treatment (complete response, partial response, stable disease, progression) will be collected.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Acronym: (SACHA)

Important dates

Study start: 2026
Primary completion: 2030
Study completion: 2030
First posted: Jul 27, 2026
Registry last updated: Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting