Health Trials

About this trial

The iLTB is a proof-of-concept initiative for children with r/r hematological malignancies, in which available treatment options will be prioritized by actionable events in a harmonized and uniform setting across Europe by a team of biologists, bio-statisticians, bio-informaticians, disease experts, geneticists, flow-experts, clinical trial physicians and also the treating physician.

The iLTB will discuss molecular (genetic lesions), immunophenotypic/surface antigen markers information and, if available, drug response profiles to prioritize these events taking into account the treatment history and treatment intention (bridging to hematopoietic stem cell transplanation/CAR-T or palliative) of each patient followed by a registry to monitor how often iLTB advice has been followed, which other therapy was chosen (off-label, compassionate use) and what the patient outcome is at an aggregated level.

As such the iLTB is non-interventional as it mainly provides advice and registers data on patients discussed in the iLTB.

Eligibility criteria

Qualifiers

The patient has been diagnosed with a R/R hematological malignancy;

The patient is less than 18 years of age at the time of first diagnosis and less than 25 years at the time of inclusion with relapse/refractory hematological malignancy;

The patient is treated in a pediatric/AYA setting or study protocol, with no current standard of care treatment;

The patients' life expectancy is at least 6 weeks;

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Advice

Treatment groups

600 Participants
are divided into 1 treatment group

Locations

7
Belgium
UH Gent Ghent Belgium
Denmark
Righospitalet Copenhagen Denmark
Hungary
Semmelweis Budapest Hungary
Netherlands
Princess Máxima Center for Pediatric Oncology3584CS, UtrechtUtrecht, Netherlands

Sponsors and collaborators

Princess Maxima Center for Pediatric Oncology

Lead sponsor

Source ClinicalTrials.gov