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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Aarhus University Hospital
Sponsor:
Information provided by (Responsible Party):
Louise Tram Henriksen, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT01272440
First received: January 5, 2011
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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
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)
  Eligibility

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Locations
Denmark
Paediatric department, Skejby University hospital Recruiting
Aarhus, Denmark, 8200
Principal Investigator: Louise T Henriksen, MD         
Sponsors and Collaborators
Aarhus University Hospital
Investigators
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:
PEG-asparaginase
children
pharmacokinetics
antibodies
acute lymphoblastic leukaemia
adverse effects

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

ClinicalTrials.gov processed this record on October 19, 2014