Clinical trial · Observational
Study of Blood and Tissue Samples in Children With Newly Diagnosed Acute Lymphoblastic Leukemia
Translational Research - Observational Study for Identification of New Possible Prognostic Factors and Future Therapeutic Targets in Children With Acute Lymphoblastic Leukemia (ALL)
- 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)
RATIONALE: Collecting and storing samples of tumor tissue, blood, bone marrow, and other body fluids from patients to test in the laboratory and collecting information about the patient's health and treatment may help doctors learn more about cancer and help the study of cancer in the future. Studying these samples in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. PURPOSE: This research study is collecting and looking at blood and tissue samples in children with newly diagnosed acute lymphoblastic leukemia.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biologic sample preservation procedure | Other | — | UNRESOLVED |
| gene expression analysis | Genetic | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| mutation analysis | Genetic | — | UNRESOLVED |
| pharmacogenomic studies | Other | — | UNRESOLVED |
| polymorphism analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (6)
- measure
- Event-free survival
- measure
- Disease-free interval from complete remission
- measure
- Response to pre-phase standard therapy
- measure
- Adverse events to induction standard therapy
- measure
- Overall survival
- measure
- Biomarker levels
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 17 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Newly diagnosed acute lymphoblastic leukemia (ALL), meeting the following criteria:
* FAB L1 or L2 morphology (any immunophenotype) and acute leukemias of ambiguous lineage (including biphenotypic or bilineal acute lymphoblastic leukemia)
* Patients with mature B-cell acute lymphoblastic leukemia (B-ALL) (FAB L3 morphology and immunophenotypical mature B phenotype or B-ALL with documented presence of karyotype t(8;14), t(2;8) t(8;22) or breakpoints as in mature B-ALL) are excluded from this study
* Patients must also meet the following criteria for participating in individual translational research (TR) project:
* TR 1 project (MRD prognostic significance in small ALL subgroups):
* All patients, categorized according to response to pre-phase (\< or \> 1,000 peripheral blasts/mm³ at day 8) and minimal-residual disease (MRD) level at end of the induction therapy
* iAmp(21q) detected at presentation
* Hypodiploidy detected at presentation by karyotype and/or fluorescence in situ hybridization (FISH) and/or DNA index
* TR 2 project (miRNAs expression in pediatric ALL):
* Initially, average-risk 1 (AR1) patients
* In a second stage, the analysis might be extended to low-risk patients that still show treatment failure and high-risk ALL patients
* TR 3 project (Prognostic value of newly described mutations in childhood B-ALL)
* Initially, only B-cell precursor ALL patients
* TR 4 project (Pharmacogenetics of the response to prephase and induction therapy):
* All ALL patients
* TR 5 project (Clinical significance of genetic abnormalities in childhood T-ALL) :
* All patients with T-cell ALL, as defined by expression of T-cell surface antigens
* TR 6 project (RAS pathway activation in childhood B-ALL):
* All patients with B-lineage ALL
* Patients with Philadelphia-chromosome positive ALL (documented presence of t(9;22)(q34;q11) and/or of the BCR/ABL fusion transcript) are eligible
* Scheduled to receive therapy as per institutional standard practice and have not started therapy (except for a maximum of 7 days of systemic corticosteroids prior to diagnosis)
* May only be registered to this study once
PATIENT CHARACTERISTICS:
* No psychological, familial, sociological, or geographical condition potentially hampering participation in the study protocol and follow-up schedule
* Patients with Down syndrome are eligible
PRIOR CONCURRENT THERAPY:
* See Disease CharacteristicsReferences
Publications (1)
- DERIVEDMatthijssens F, Sharma ND, Nysus M, Nickl CK, Kang H, Perez DR, Lintermans B, Van Loocke W, Roels J, Peirs S, Demoen L, Pieters T, Reunes L, Lammens T, De Moerloose B, Van Nieuwerburgh F, Deforce DL, Cheung LC, Kotecha RS, Risseeuw MD, Van Calenbergh S, Takarada T, Yoneda Y, van Delft FW, Lock RB, Merkley SD, Chigaev A, Sklar LA, Mullighan CG, Loh ML, Winter SS, Hunger SP, Goossens S, Castillo EF, Ornatowski W, Van Vlierberghe P, Matlawska-Wasowska K. RUNX2 regulates leukemic cell metabolism and chemotaxis in high-risk T cell acute lymphoblastic leukemia. J Clin Invest. 2021 Mar 15;131(6):e141566. doi: 10.1172/JCI141566. PMID 33555272