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

NCT01305655 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2018-09-28

Study results available
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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.

Conditions

  • Acute Lymphoblastic Leukemia (ALL)

Interventions

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.

Sponsors & Collaborators

  • Lund University Hospital

    collaborator OTHER

  • Nordic Society for Pediatric Hematology and Oncology

    lead OTHER

Principal Investigators

  • Jesper Heldrup, M D · University Childrens hospital, Lund, Sweden

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Denmark
  • Finland
  • Iceland
  • Norway
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01305655 on ClinicalTrials.gov