Status:
UNKNOWN
Study of Blood and Tissue Samples in Children With Newly Diagnosed Acute Lymphoblastic Leukemia
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
1-17 years
Brief Summary
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 t...
Detailed Description
OBJECTIVES: * Collect clinical data in parallel with biological data and samples from children with newly diagnosed acute lymphoblastic leukemia for biobanking, and use part of the biobanked material...
Eligibility Criteria
Inclusion
- 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 Characteristics
Exclusion
Key Trial Info
Start Date :
June 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT01185886
Start Date
June 1 2011
End Date
June 1 2021
Last Update
July 28 2017
Active Locations (21)
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1
Universitair Ziekenhuis Antwerpen
Antwerp, Belgium
2
Cliniques Universitaires Saint-Luc
Brussels, Belgium
3
Hopital Universitaire Des Enfants Reine Fabiola
Brussels, Belgium
4
Universitair Ziekenhuis Brussel
Brussels, Belgium