MedTrace Logo

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

NCT01272440 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2013-11-13

No results posted yet for this study

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

Conditions

  • Acute Lymphoblastic Leukaemia

Sponsors & Collaborators

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Louise T Henriksen, MD · Aarhus University Hospital

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01272440 on ClinicalTrials.gov