Nordic Society of Paediatric Haematology and Oncology Treatment Protocol for Children (1.0 - 17.9 Years of Age) and Young Adults (18-45 Years of Age) With ALL. Efficacy of Individualised 6MP Dosing During Consolidation Therapy
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 increase the fraction of patients, who become MRD-negative during consolidation for the
non-HR ALL group through individualised intensification of the 6MP-dosage days 30-85. We
will additionally measure EFS and toxicity as secondary end points of effect.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Fraction of patients that become MRD-negative at treatment days 85 and/or 92 (end-of-consolidation) and event-free survival. MRD is measured either by Flow-cytometry (for PreB-ALL patients) or PCR for clonal generearrangements(for T-ALL patients)
Kjeld Schmiegelow, M.D.
Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen
Denmark: Danish Medicines Agency
NOPHO ALL2008 consolidation