RecruitingNot Applicable

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

Belgium1,600 participantsStarted 2026-07

Plain-language 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.

Who can participate

Age range

0 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Collect safety data

Timeframe: through study completion, an average of 1 year

Collect activity data

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT07727694

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2030-12-31

View on ClinicalTrials.gov More Pediatric Cancer trials