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

NCT ID: NCT01272440

Last Updated: 2013-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Acute Lymphoblastic Leukaemia

Keywords

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PEG-asparaginase children pharmacokinetics antibodies acute lymphoblastic leukaemia adverse effects

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Louise Tram Henriksen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Louise T Henriksen, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

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Paediatric department, Skejby University hospital

Aarhus, Denmark, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Louise T Henriksen, MD

Role: CONTACT

Phone: +45 89496771

Email: [email protected]

Other Identifiers

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LTH-1

Identifier Type: -

Identifier Source: org_study_id