Acute Lymphoblastic Leukemia (ALL) Clinical Trial
Official title:
Glucarpidase (CPG2) Effect on Severe Delayed Methotrexate-clearance in Children Treated With High-dose Methotrexate in Acute Lymphoblastic Leukemia (ALL)
Early intervention in children and adolescents who experience delayed MTX-clearance and renal dysfunction in ALL treatments with the enzyme Glucarpidase which rapidly hydrolyses MTX to non-toxic metabolites to avoid life threatening complications.
The NOPHO 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 with the aim to reduce and prevent toxic treatment complications with high-dose
methotrexate (HD-MTX).
The specific and primary objectives of the randomized study is:
1. Early intervention in children and adolescents who experience delayed MTX-clearance and
renal dysfunction with the enzyme Glucarpidase which rapidly hydrolyses MTX to non-toxic
metabolites and lowers the serum concentration to avoid life threatening complications.
Glucarpidase should be given if the 24 hour levels of MTX is > 250 µM, 36 hour levels >
30 µM or 42 hours levels > 10 µM together with a reduced kidney function. Glucarpidase
treatment should take place within 48 hours from the start of HD-MTX treatment.
2. To evaluate if the early intervention with Glucarpidase reduce the number of days the
patients have to stay at the hospital.
3. Evaluate the reduction of health costs of early intervention in patients with delayed
MTX-clearance and renal dysfunction.
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