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A Drug Monitoring Study on PEG-asparaginase Treatment in Children Diagnosed Acute Lymphoblastic Leukaemia

Sponsor
Aarhus University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01272440
Collaborator
(none)
200
Enrollment
1
Location
59
Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Asparaginase is an important drug i the treatment of childhood leukaemia.

The aim of this project is to study the pharmacokinetics, pharmacodynamics and antibody development and hypersensitivity reactions during prolonged PEG-asparaginase treatment.

Study part 1) Asparaginase pharmacokinetics and pharmacodynamics during prolonged PEG-asparaginase treatment: A NOPHO ALL-2008 study

Study part 2) Asparagine depletion in cerebrospinal fluid: A NOPHO ALL-2008 study

Study part 3) A characterization of PEG-asparaginase hypersensitivity in children treated according to the NOPHO ALL 2008 protocol

Perspectives: New knowledge about PEG-asparaginase treatment regarding dosing, dosing interval, adverse effects and EFS, which may lead to improved future therapy

Patients: Children diagnosed with acute lymphoblastic leukaemia in the Nordic Countries

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    PEG-asparaginase Treatment in the NOPHO ALL-2008 Protocol: Antibody Formation, Pharmacokinetics, Pharmacodynamics and Side Effects.
    Study Start Date :
    Jan 1, 2011
    Anticipated Primary Completion Date :
    Dec 1, 2015
    Anticipated Study Completion Date :
    Dec 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. Asparagine depletion [Up to 30 weeks of treatment]

      Blood samples and cerebrospinal fluid samples are collected at certain timepoints during 30 weeks of treatment with PEG-asparaginase. They are analyzed for asparagine, asparaginase-enzyme activity and asparaginase-antibodies.These measures tell about the effect of the drug, PEG-asparaginase.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Children aged between 1 and 18 years old, diagnosed ALL and treated according to the NOPHO-ALL 2008 protocol and who have accepted to participate in this study

    Exclusion Criteria:

    Children that does not attend the NOPHO-ALL 2008 protocol but receives standard treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Paediatric department, Skejby University hospital Aarhus Denmark 8200

    Sponsors and Collaborators

    • Aarhus University Hospital

    Investigators

    • Principal Investigator: Louise T Henriksen, MD, Aarhus University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Louise Tram Henriksen, MD, Aarhus University Hospital
    ClinicalTrials.gov Identifier:
    NCT01272440
    Other Study ID Numbers:
    • LTH-1
    First Posted:
    Jan 7, 2011
    Last Update Posted:
    Nov 13, 2013
    Last Verified:
    Nov 1, 2013
    Keywords provided by Louise Tram Henriksen, MD, Aarhus University Hospital
    PEG-asparaginase
    children
    pharmacokinetics
    antibodies
    acute lymphoblastic leukaemia
    adverse effects
    Additional relevant MeSH terms:
    Leukemia
    Precursor Cell Lymphoblastic Leukemia-Lymphoma
    Leukemia, Lymphoid

    Study Results

    No Results Posted as of Nov 13, 2013