Study of Blood and Tissue Samples in Children With Newly Diagnosed Acute Lymphoblastic Leukemia

NCT01185886 | Unknown DMC

• 2 other identifiers: EORTC-58081EU-21057
• Study Type: observational
• Target: 1,200
• Locations: 3 countries
• Sites: 21

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 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

Leukemia; Lymphoma

Keywords

untreated childhood acute lymphoblastic leukemia; L1 childhood acute lymphoblastic leukemia; L2 childhood acute lymphoblastic leukemia; B-cell childhood acute lymphoblastic leukemia; T-cell childhood acute lymphoblastic leukemia; stage I childhood lymphoblastic lymphoma; stage II childhood lymphoblastic lymphoma; stage III childhood lymphoblastic lymphoma; stage IV childhood lymphoblastic lymphoma; Philadelphia chromosome positive childhood precursor acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (6)

• Event-free survival

• Disease-free interval from complete remission

• Response to pre-phase standard therapy

• Adverse events to induction standard therapy

• Overall survival

• Biomarker levels

Interventions

gene expression analysis GENETIC

mutation analysis GENETIC

polymorphism analysis GENETIC

biologic sample preservation procedure OTHER

laboratory biomarker analysis OTHER

pharmacogenomic studies OTHER

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (21)

Universitair Ziekenhuis Antwerpen

Antwerp, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Location

Hopital Universitaire Des Enfants Reine Fabiola

Brussels, Belgium

Location

Universitair Ziekenhuis Brussel

Brussels, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, B-9000, Belgium

Location

U.Z. Leuven - Campus Gasthuisberg

Leuven, Belgium

Location

Centre Hospitalier Regional De La Citadelle

Liège, Belgium

Location

CHRU de Besancon - Hopital Saint-Jacques

Besançon, France

Location

CHU de Caen - Hopital Cote de Nacre

Caen, France

Location

CHU de Grenoble - La Tronche - Hôpital A. Michallon

Grenoble, France

Location

CHRU de Lille

Lille, France

Location

Hospices Civils de Lyon

Lyon, 65008, France

Location

Hopital Arnaud De Villeneuve

Montpellier, France

Location

CHU de Nice - Hopital De L'Archet

Nice, France

Location

CHU - Hopital Robert Debre

Paris, 75935, France

Location

Hopital Jean Bernard

Poitiers, France

Location

CHU de Reims - American Memorial Hospital

Reims, France

Location

Centre Hospitalier Félix Guyon

Saint-Denis, France

Location

Hopitaux Universitaires de Strasbourg - Hautepierre

Strasbourg, France

Location

CHU de Toulouse - C.H.U. De Toulouse - Hopital Des Enfants

Toulouse, France

Location

Instituto Portugues De Oncologia - Centro Do Porto

Porto, Portugal

Location

Related Publications (1)

• Matthijssens 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 DERIVED

MeSH Terms

Conditions

Leukemia; Lymphoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Gene Expression Profiling; Amplified Fragment Length Polymorphism Analysis; Pharmacogenomic Testing

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid

Intervention Hierarchy (Ancestors)

Genetic Techniques; Investigative Techniques; DNA Fingerprinting; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Helene Cave

  CHU - Hopital Robert Debre

  PRINCIPAL INVESTIGATOR

• Yves Benoit, MD

  University Ghent

  PRINCIPAL INVESTIGATOR

• Yves Bertrand, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2010
• First Posted: August 20, 2010
• Study Start: June 1, 2011
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: July 28, 2017

Record last verified: 2017-07

Locations

PT (1); FR (13); BE (7)