Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00192673
Status:
UNKNOWN
Last Update Posted:
2009-09-30
First Post:
2005-09-11
Brief Title:
PolyEthylene GlycolPEG-Asparaginase During Two Treatment Courses
Sponsor:
Nordic Society for Pediatric Hematology and Oncology
Organization:
Nordic Society for Pediatric Hematology and Oncology
Study Overview
Official Title:
PEG-asparaginase During Two Treatment Courses in the Treatment of Childhood Acute Lymphoblastic Leukemia
Status:
UNKNOWN
Status Verified Date:
2009-09
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:
The purpose of this study is
1 to determine the correct dose for intramuscular administration
2 to compare the frequency of antibody formation after intramuscular administration of native Ecoli asparaginase and PEG-asparaginase during two treatment courses in the treatment of childhood lymphoblastic leukemia
1 to determine the correct dose for intramuscular administration
2 to compare the frequency of antibody formation after intramuscular administration of native Ecoli asparaginase and PEG-asparaginase during two treatment courses in the treatment of childhood lymphoblastic leukemia
Detailed Description:
Asparaginase is used in the treatment of childhood lymphoblastic leukemia Approximately 13 of the patients develops blocking antibodies against native Ecoli asparaginase during the second exposure so that they do not benefit from treatment and thus may have a worse prognosis
PEG-asparaginase is less immunogenic so that fewer patients may develop antibodies during the second exposure
There is no published study about the antibody formation after treatment of children with PEG-asparaginase during two treatment courses
The first part of the study is a description of the pharmacokinetics of PEG-asparaginase after intramuscular administration in order to determine the correct dose
The second part of the study is a comparison of antibody formation during two treatment courses after intramuscular administration og native Ecoli asparaginase and PEG-asparaginase
Other side effects than antibodies will be registered during treatment with PEG-asparaginase Finally comparison of the 5-year EFS between the groups native Ecoli asparaginase and PEG-asparaginase as well as patients who have and have not developed antibodies will be evaluated
PEG-asparaginase is less immunogenic so that fewer patients may develop antibodies during the second exposure
There is no published study about the antibody formation after treatment of children with PEG-asparaginase during two treatment courses
The first part of the study is a description of the pharmacokinetics of PEG-asparaginase after intramuscular administration in order to determine the correct dose
The second part of the study is a comparison of antibody formation during two treatment courses after intramuscular administration og native Ecoli asparaginase and PEG-asparaginase
Other side effects than antibodies will be registered during treatment with PEG-asparaginase Finally comparison of the 5-year EFS between the groups native Ecoli asparaginase and PEG-asparaginase as well as patients who have and have not developed antibodies will be evaluated
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2004-41-4276 | None | None | None |
| 20040177 | None | None | None |