International Leukemia Target Board
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-25
SponsorPrincess Maxima Center for Pediatric Oncology
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
This trial does not accept healthy volunteersQualifiers
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 population
Children less than 18 years of age at the time of first diagnosis and less than 25 years at the time of inclusion with relapsed/refractory ALL, AML or LBL while being treated in a pediatric/AYA center, and for whom no standard of care treatment is available, and for whom molecular and flow cytometry profiling are available for iLTB discussion, and where the national group supports discussing the patient in the iLTB.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Advice
Other interventionnon-interventional study
Treatment groups
600 Participants
are divided into 1 treatment groupGroup A: Relapsed leukemia1 intervention
Trial outcomes
Primary outcomes
1
The proportion of patients receiving therapy according to the iLTB advice after providing the treating physician with a uniform prioritization of therapy options based on the patient's actionable events.
Time frame
through study completion, an average of 8 yearsSecondary outcomes
1
Harmonized algorithm to prioritize actionable events options in Europe
Time frame
through study completion, an average of 8 years2
Harmonized algorithm to prioritize treatment options in Europe is available
Time frame
through study completion, an average of 8 years3
Number and frequencies of different types of actionable events reported in the database
Time frame
through study completion, an average of 8 years4
Number of patients being treated with targeted agent according to iLTB advice and compare to previously reported literature by single molecular tumor board initiatives experience
Time frame
through study completion, an average of 8 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov