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

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ClinicalTrials.gov Identifier: NCT01272440
Recruitment Status : Unknown
Verified November 2013 by Louise Tram Henriksen, Aarhus University Hospital.
Recruitment status was:  Recruiting
First Posted : January 7, 2011
Last Update Posted : November 13, 2013
Information provided by (Responsible Party):

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
Acute Lymphoblastic Leukaemia

Study Design

Study Type : Observational
Estimated 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 : January 2011
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Asparagine depletion [ Time Frame: 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.

Biospecimen Retention:   Samples With DNA
Blood, Cerebrospinal fluid

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Louise Tram Henriksen, MD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01272440     History of Changes
Other Study ID Numbers: LTH-1
First Posted: January 7, 2011    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013

Keywords provided by Louise Tram Henriksen, Aarhus University Hospital:
acute lymphoblastic leukaemia
adverse effects

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