Clinical trial · Observational
International Leukemia Target Board
International Concerted Action to Allocate Children, Adolescents and Young Adults With Relapsed and Refractory Leukemia/Lymphoma to the Right Therapy.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | CURATED_BROADER | 0.78 |
| Relapsed Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Advice | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Relapsed leukemia
- description
- T-ALL: First relapse with high MRD after re-induction Newly diagnosed with high MRD after consolidation B-ALL: 1st relapse high risk group, Second or higher relapse, post CAR-T or post HSCT AML: Second or higher relapse
- interventionNames
- Other: Advice
Primary outcomes (1)
- measure
- 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.
- timeFrame
- through study completion, an average of 8 years
Secondary outcomes (9)
- measure
- Harmonized algorithm to prioritize actionable events options in Europe
- timeFrame
- through study completion, an average of 8 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 25 Years
Show eligibility criteria text
Inclusion criteria 1. The patient has been diagnosed with a R/R hematological malignancy; 2. 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; 3. The patient is treated in a pediatric/AYA setting or study protocol, with no current standard of care treatment; 4. The patients' life expectancy is at least 6 weeks; 5. The patient has undergone any sort of molecular profiling of his/her tumor and the re-sults of this analysis are available; 6. The patient has undergone flow cytometry in a certified lab and results are available; 7. 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. Exclusion criteria: none defined
References
Publications (0)
Data not yet available