NCT01305655

Glucarpidase Effect on Severe Delayed HDM-clearance in Children Treated With High-dose Mtx in ALL

Glucarpidase (CPG2) Effect on Severe Delayed Methotrexate-clearance in Children Treated With High-dose Methotrexate in Acute Lymphoblastic Leukemia (ALL)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Nordic Society for Pediatric Hematology and Oncology · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Lymphoblastic Leukemia (ALL)

Interventions

Type	Name	Description
DRUG	Glucarpidase	Patients treated with Glucarpidase 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 will be compared with patients in just below the tricking values.

Timeline

• Start date: 2008-07-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2011-03-01
• Last updated: 2018-09-28
• Results posted: 2017-02-03

Locations

5 sites across 5 countries: Denmark, Finland, Iceland, Norway, Sweden