Acute Lymphoblastic Leukemia
Conditions
Keywords
acute lymphoblastic leukemia, child, PEG-Asparaginase, EFS, efficacy, childhood acute lymphoblastic leukemia
Brief summary
The purpose of this study is to investigate if intramuscular PEG-asparaginase administered either at six or two week intervals from day 92 until 8 months from diagnosis for patients with non-HR ALL will result in equal probability of Event Free Survival
Detailed description
20% of children with ALL still fails to be cured. The ALL-2008 protocol is a treatment and research protocol that aims to improve the overall outcome of Nordic children and adolescents with ALL in comparison with the ALL-2000 protocol and previous NOPHO protocols. The specific and primary objectives of the randomised study is: To test if intramuscular PEG-asparaginase administered either at six or two week intervals from day 92 until 8 months from diagnosis for patients with non-HR ALL will result in equal probability of EFS. As secondary endpoints asparaginase antibody production and toxicity including allergic reactions in the treatment-arms will be analysed
Interventions
DRUGPEG Asparaginase at six weeks interval
PEG-asparaginase (1.000 IU/m2/dose) given at six weeks intervals (until the patient has received 33 weeks of therapy)
DRUGPEG Asparaginase at two weeks interval
PEG-asparaginase (1.000 IU/m2/dose) given at two weeks intervals (until the patient has received 33 weeks of therapy)
Sponsors
Nordic Society for Pediatric Hematology and Oncology
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Childhood ALL * All mandatory biological data are available6 * Written informed consent has been obtained
Exclusion criteria
* Bilineage ALL * Pre-treatment with glucocorticosteroids or other antileukemic agents for more than 1 week * ALL predisposition syndromes * Previous cancer * Off protocol administration of additional chemotherapy during induction therapy * Sexually active females not using contraception * No allergic reactions to PEG Asparaginase
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event Free Survival | 6 years |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome Measures are toxicity (special focus on thrombosis, pancreatitis, and allergic reactions), the formation of silent antibodies, and the influence of antibody production on the EFS. | 6 years |
Countries
Denmark, Finland, Iceland, Norway, Sweden
Outcome results
None listed