International Leukemia Target Board
International Concerted Action to Allocate Children, Adolescents and Young Adults With Relapsed and Refractory Leukemia/Lymphoma to the Right Therapy.
Princess Maxima Center for Pediatric Oncology
600 participants
Dec 31, 2022
OBSERVATIONAL
Conditions
Summary
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
Inclusion Criteria7
- 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;
- The patient has undergone any sort of molecular profiling of his/her tumor and the re-sults of this analysis are available;
- The patient has undergone flow cytometry in a certified lab and results are available;
- Written informed consent of patient and/or parent(s)/guardian(s) to discuss the patient in the iLTB according to local law and legislation has been obtained.
Interventions
non-interventional study
Locations(7)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05270096