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

This study is currently recruiting participants.
Verified November 2013 by Aarhus University Hospital
Information provided by (Responsible Party):
Louise Tram Henriksen, Aarhus University Hospital
ClinicalTrials.gov Identifier:
First received: January 5, 2011
Last updated: November 12, 2013
Last verified: November 2013

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

Acute Lymphoblastic Leukaemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: PEG-asparaginase Treatment in the NOPHO ALL-2008 Protocol: Antibody Formation, Pharmacokinetics, Pharmacodynamics and Side Effects.

Resource links provided by NLM:

Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • Asparagine depletion [ Time Frame: Up to 30 weeks of treatment ] [ Designated as safety issue: No ]
    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.

Biospecimen Retention:   Samples With DNA

Blood, Cerebrospinal fluid

Estimated Enrollment: 200
Study Start Date: January 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children aged between 1 and 18 years old, diagnosed ALL and treated according to the NOPHO-ALL 2008 protocol


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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272440

Contact: Louise T Henriksen, MD +45 89496771 LOUISE.TRAM.HENRIKSEN@KI.AU.DK

Paediatric department, Skejby University hospital Recruiting
Aarhus, Denmark, 8200
Principal Investigator: Louise T Henriksen, MD         
Sponsors and Collaborators
Aarhus University Hospital
Principal Investigator: Louise T Henriksen, MD Aarhus University Hospital
  More Information

No publications provided

Responsible Party: Louise Tram Henriksen, MD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01272440     History of Changes
Other Study ID Numbers: LTH-1
Study First Received: January 5, 2011
Last Updated: November 12, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Aarhus University Hospital:
acute lymphoblastic leukaemia
adverse effects

Additional relevant MeSH terms:
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014