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LeukemiaNCT01185886

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

An observational study of Leukemia and Lymphoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 21 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 year to 17 years
Conditions the study is for
Leukemia, Lymphoma
What is being tested?
gene expression analysis, mutation analysis and polymorphism analysis
How many people
1,200 participants
Where
21 sitesin 3 countries
Study dates
Jun 2011to Jun 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 17 years
  • All sexes
  • No healthy volunteers
  • Child

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

Trial locations and contacts

21 sites in 3 countries.

21 sites in 3 countries

France13 sites

  • CHRU de Besancon - Hopital Saint-Jacques

    Besançon

  • CHU de Caen - Hopital Cote de Nacre

    Caen

  • CHU de Grenoble - La Tronche - Hôpital A. Michallon

    Grenoble

  • CHRU de Lille

    Lille

  • Hospices Civils de Lyon

    Lyon, 65008

  • Hopital Arnaud De Villeneuve

    Montpellier

  • CHU de Nice - Hopital De L'Archet

    Nice

  • CHU - Hopital Robert Debre

    Paris, 75935

  • Hopital Jean Bernard

    Poitiers

  • CHU de Reims - American Memorial Hospital

    Reims

  • Centre Hospitalier Félix Guyon

    Saint-Denis

  • Hopitaux Universitaires de Strasbourg - Hautepierre

    Strasbourg

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

    Toulouse

Other trials in France

Belgium7 sites

  • Universitair Ziekenhuis Antwerpen

    Antwerp

  • Cliniques Universitaires Saint-Luc

    Brussels

  • Hopital Universitaire Des Enfants Reine Fabiola

    Brussels

  • Universitair Ziekenhuis Brussel

    Brussels

  • Universitair Ziekenhuis Gent

    Ghent, B-9000

  • U.Z. Leuven - Campus Gasthuisberg

    Leuven

  • Centre Hospitalier Regional De La Citadelle

    Liège

Other trials in Belgium

Portugal1 site

  • Instituto Portugues De Oncologia - Centro Do Porto

    Porto

Other trials in Portugal

About this study

Official title: Translational Research - Observational Study for Identification of New Possible Prognostic Factors and Future Therapeutic Targets in Children With Acute Lymphoblastic Leukemia (ALL)

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.

Read the 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 to perform specific translational projects to achieve objectives II-IV.
  • To identify new prognostic factors (e.g., minimal-residual disease [MRD] significance in small subgroups, miRNAs expression profile, PAX5 mutation, genetic abnormalities in T-cell acute lymphoblastic leukemia [T-ALL], and RAS pathway activation) and future therapeutic targets in children with newly diagnosed acute lymphoblastic leukemia.
  • To identify leukemia cell genetic alterations (e.g., mutations in T-ALL and miRNA expression in B-cell acute lymphoblastic leukemia [B-ALL]) and related molecular pathways (e.g., RAS pathway) underlying leukemogenesis.
  • To identify patient pharmacogenetic polymorphisms impacting individual response to corticosteroids as part of standard therapy and investigate their prognostic significance.

OUTLINE: This is a prospective observational biobanking study.

Patients undergo clinical evaluation, laboratory tests, and imaging periodically. Data are collected before, during, and after first-line standard therapy. Clinical data are collected from all patients in parallel with the biological data and samples. Biological samples are partly used to perform specific translational research (TR) projects. Remaining biological materials are stored for future research.

The following TR projects are performed on the biological samples for this study. Biological samples are analyzed for allele-specific amplification of Ig/TCR clonal rearrangements to quantify minimal-residual disease (MRD) via real-time PCR (TR1 Project); miRNA expression via qPCR (TR 2 Project); the detection of main point mutations via high-resolution melting PCR (TR 3 Project); genetic polymorphisms via real-time TaqMan allelic-discrimination method (TR 4 Project); clinical significance of genetic abnormalities via quantitative real-time RT-PCR, direct sequencing, and fluorescence in situ hybridization (TR 5 Project); and RAS pathway activation via single-nucleotide polymorphism (SNP) analysis and gene-expression analysis (TR 6 Project).

Conditions
Leukemia, Lymphoma
Being tested
gene expression analysis, mutation analysis, polymorphism analysis, biologic sample preservation procedure, laboratory biomarker analysis
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
Medical subject headings
Leukemia, Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gene expression analysisGenetic

  • mutation analysisGenetic

  • polymorphism analysisGenetic

  • biologic sample preservation procedureOther

  • laboratory biomarker analysisOther

  • pharmacogenomic studiesOther

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-free survival

  2. Disease-free interval from complete remission

  3. Response to pre-phase standard therapy

  4. Adverse events to induction standard therapy

  5. Overall survival

  6. Biomarker levels

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2010 (estimated)
  2. Study startJun 2011
  3. Primary completionJun 2021 (estimated)
  4. Study completionJun 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
1,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01185886
Sponsor's protocol ID
EORTC-58081
Other IDs
EORTC-58081, EU-21057
Status last verified
Jul 2017
First submitted
19 Aug 2010
Last updated
28 Jul 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 33555272

Questions about this trial

What is this clinical trial studying?

An observational study of Leukemia and Lymphoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 21 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in France, Belgium, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-free survival. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01185886, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2017.

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