At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 47 enrolled
Drug / intervention
Glucarpidasedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Glucarpidase (CPG2) Effect on Severe Delayed Methotrexate-clearance in Children Treated With High-dose Methotrexate in Acute Lymphoblastic Leukemia (ALL)
Nordic Society for Pediatric Hematology and Oncology·interventional·Posted Mar 1, 2011·Updated Sep 28, 2018
In Brief
A Phase 3 clinical trial evaluating Glucarpidase for Acute Lymphoblastic Leukemia (ALL). Completed, enrolled 47 participants across 5 sites in 5 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Lymphoblastic Leukemia (ALL)
CountriesDenmark, Finland, Iceland, Norway, Sweden
CollaboratorsLund University Hospital
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2008
First PostedMar 2011
Primary CompletionDec 2014
TodayJul 2026
First PostedMar 1, 2011
Enrollment StartJul 1, 2008
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 15.3 years ago
Interventions
Glucarpidasedrug
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.