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Can off-label cancer drugs help children? a national study aims to find out

NCT ID NCT07727694

Knowledge-focused Sponsor: Universitaire Ziekenhuizen KU Leuven Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time

Summary

This study collects safety and effectiveness data on cancer medicines used off-label or through compassionate access in children, adolescents, and young adults up to age 25 with pediatric malignancies. Participants are not enrolled in other treatment trials and are discussed by expert tumor boards. The goal is to gather real-world evidence on how these innovative drugs work in younger patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
off-label or compassionate-use cancer medicines (targeted therapies, immunotherapies, chemotherapies) approved in adults after 2007
What this could lead to
If successful, this could provide real-world evidence to support safer and more effective use of innovative cancer drugs in children and young adults.
What could go wrong
This is an observational data collection study, not a controlled trial, so it cannot prove cause and effect. Results may be limited by incomplete data or differences in how patients are treated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,600 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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 compassionate use or outside marketing authorization, in one of the centers of the pediatric hemato-oncology centers in Belgium

Ages

0 to 25 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

childhood malignant neoplasm neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pediatric cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHC Montlégia

    NOT_YET_RECRUITING

    Liège, 4000, Belgium

  • Cliniques Universitaires Saint-Luc

    NOT_YET_RECRUITING

    Brussels, 1200, Belgium

  • Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)

    NOT_YET_RECRUITING

    Brussels, 1020, Belgium

  • University Hospital Antwerp

    NOT_YET_RECRUITING

    Antwerp, 2650, Belgium

  • University Hospital Gent

    NOT_YET_RECRUITING

    Ghent, 9000, Belgium

  • University Hospital Leuven

    RECRUITING

    Leuven, 3000, Belgium

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