Ignite Creation Date:
2024-05-05 @ 11:11 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01272440
Status:
UNKNOWN
Last Update Posted:
2013-11-13
First Post:
2011-01-05
Brief Title:
A Drug Monitoring Study on PEG-asparaginase Treatment in Children Diagnosed Acute Lymphoblastic Leukaemia
Sponsor:
Aarhus University Hospital
Organization:
Aarhus University Hospital
Study Overview
Official Title:
PEG-asparaginase Treatment in the NOPHO ALL-2008 Protocol Antibody Formation Pharmacokinetics Pharmacodynamics and Side Effects
Status:
UNKNOWN
Status Verified Date:
2013-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None