The purpose of this study is to increase the fraction of patients, who become MRD-negative during consolidation for the non-HR ALL group through individualized intensification of the 6MP-dosage days 30-85.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
775
Oral 6-mercaptopurine with a starting dose of 25 mg/m2 and upward adjusted in steps of 25 mg/m2 (i.e. 50 or 75 mg/m2) if unacceptable bone-marrox toxicity is not encountered
Oral 6-mercaptopurine at a fixed dose of 25 mg/m2 treatment days 30-85
Department of Pediatrics, Rigshospitalet
Copenhagen, Denmark
Helsinki University Hospital
Helsinki, Finland
University Hospital
Reykjavik, Iceland
Trondheim University Hospital
Trondheim, Norway
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)
Time frame: 6 years
Toxicity of treatment, degree of myelo-, hepato- and renal toxicity; and development of asparaginase antibodies.
Time frame: 6 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Department of Pediatrics, Drottning Sylvias Pediatric Hospital
Gothenburg, Sweden
NOPHO nordic organisation for pediatric onology
Stockholm, Sweden