Phase 3
N=47
Glucarpidase Effect on Severe Delayed HDM-clearance in Children Treated With High-dose Mtx in ALL
Acute Lymphoblastic Leukemia (ALL)
Bottom Line
View on ClinicalTrials.gov: NCT01305655 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Number of Participants With Adverse Event to HD-MTX Treatment in NOPHO ALL-2008 as a Measure of Toxic Mtx Concentrations in Blood, Nephrotoxicity, Hepatotoxicity, Mucositis, MTX Elimination Time and Permanent Kidney Damage. — 47 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Glucarpidase (Drug)
- Age
- Pediatric, Adult · 1+ yrs
- Sex
- All
- Sponsor
- Nordic Society for Pediatric Hematology and Oncology
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Event to HD-MTX Treatment in NOPHO ALL-2008 as a Measure of Toxic Mtx Concentrations in Blood, Nephrotoxicity, Hepatotoxicity, Mucositis, MTX Elimination Time and Permanent Kidney Damage. |
47 | — |
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.
Eligibility Criteria
Inclusion Criteria
Children and adolescents who experience delayed MTX-clearance and renal dysfunction during high-dose methotrexate treatment in NOPHO ALL-2008.
Exclusion Criteria
Children and adolescents with earlier anaphylactic reaction to Glucarpidase. Pregnant patients.
Data sourced from ClinicalTrials.gov (NCT01305655). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.