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

Acute Lymphoblastic Leukaemia Clinical Trial

Official title:
PEG-asparaginase Treatment in the NOPHO ALL-2008 Protocol: Antibody Formation, Pharmacokinetics, Pharmacodynamics and Side Effects.

Status Recruiting

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Acute Lymphoblastic Leukaemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma

Clinical Trial Details

NCT number	NCT01272440
Study type	Observational
Source	Aarhus University Hospital
Contact	Louise T Henriksen, MD
Phone	+45 89496771
Email	LOUISE.TRAM.HENRIKSEN@KI.AU.DK
Status	Recruiting
Phase	N/A
Start date	January 2011
Completion date	December 2015

View Details

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