NOPHO Treatment Protocol for Children (1.0 - 17.9 Years of Age) and Young Adults(18.0-45.0 Years) With Acute Lymphoblastic Leukemia. Intermittent Versus Continuous PEG-asparaginase for Asparagine Depletion
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
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Event Free Survival
Kjeld Schmiegelow, M.D.
Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen
Denmark: Danish Medicines Agency
NOPHO ALL2008 PEG Asparaginase