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

July 26, 2017 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium
        • Universitair Ziekenhuis Antwerpen
      • Brussels, Belgium
        • Cliniques Universitaires Saint-Luc
      • Brussels, Belgium
        • Hôpital Universitaire Des Enfants Reine Fabiola
      • Brussels, Belgium
        • Universitair Ziekenhuis Brussel
      • Ghent, Belgium, B-9000
        • Universitair Ziekenhuis Gent
      • Leuven, Belgium
        • U.Z. Leuven - Campus Gasthuisberg
      • Liege, Belgium
        • Centre Hospitalier Régional de la Citadelle
  • France
      • Besancon, France
        • CHRU de Besancon - Hopital Saint-Jacques
      • Caen, France
        • CHU de Caen - Hopital Cote de Nacre
      • Grenoble, France
        • CHU de Grenoble - La Tronche - Hôpital A. Michallon
      • Lille, France
        • CHRU de Lille
      • Lyon, France, 65008
        • Hospices Civils de Lyon
      • Montpellier, France
        • Hôpital Arnaud de Villeneuve
      • Nice, France
        • CHU de Nice - Hôpital de l'Archet
      • Paris, France, 75935
        • Chu - Hôpital Robert Debre
      • Poitiers, France
        • Hopital Jean Bernard
      • Reims, France
        • CHU de Reims - American Memorial Hospital
      • Saint-Denis, France
        • Centre Hospitalier Félix Guyon
      • Strasbourg, France
        • Hopitaux Universitaires de Strasbourg - Hautepierre
      • Toulouse, France
        • CHU de Toulouse - C.H.U. De Toulouse - Hopital Des Enfants
  • Portugal
      • Porto, Portugal
        • Instituto Portugues De Oncologia - Centro Do Porto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival
Event-free survival
Disease-free interval from complete remission
Response to pre-phase standard therapy
Adverse events to induction standard therapy
Biomarker levels

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Principal Investigator: Helene Cave, Chu - Hôpital Robert Debre
  • Principal Investigator: Yves Benoit, MD, Universitair Ziekenhuis Gent
  • Principal Investigator: Yves Bertrand, MD, Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2011

Primary Completion (ANTICIPATED)

June 1, 2021

Study Completion (ANTICIPATED)

June 1, 2021

Study Registration Dates

First Submitted

August 19, 2010

First Submitted That Met QC Criteria

August 19, 2010

First Posted (ESTIMATE)

August 20, 2010

Study Record Updates

Last Update Posted (ACTUAL)

July 28, 2017

Last Update Submitted That Met QC Criteria

July 26, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-58081
  • EU-21057

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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