PEG-asparaginase During Two Treatment Courses in the Treatment of Childhood Acute Lymphoblastic Leukemia
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 85
- Locations
- 2
- Primary Endpoint
- Determination of the dose that secures sufficient treatment during 14 days
Study Overview
Brief Summary
The purpose of this study is
- to determine the correct dose for intramuscular administration
- to compare the frequency of antibody formation after intramuscular administration of native E.coli 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 1/3 of the patients develops blocking antibodies against native E.coli 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 E.coli asparaginase and PEG-asparaginase.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1-17 years
- •Newly diagnosed ALL (high intensive)
- •Treated according to the NOPHO-2000 protocol
- •Treated at one of the Nordic pediatric oncology centers
Exclusion Criteria
- •<1 year and >18 years
- •Newly diagnosed ALL other than high intensive
- •Not treated according to the NOPHO-2000 protocol
- •Not treated at one of the Nordic pediatric oncology centers
- •Allergy to the contents
- •Pancreatitis (Active or earlier)
Outcomes
Primary Outcomes
Determination of the dose that secures sufficient treatment during 14 days
Determination of the frequency of antibody formation during treatment with PEG-asparaginase during two treatment courses
Secondary Outcomes
- Comparison of 5-year EFS between groups