Glucarpidase Effect on Severe Delayed HDM-clearance in Children Treated With High-dose Mtx in ALL
NCT ID: NCT01305655
Last Updated: 2018-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
47 participants
INTERVENTIONAL
2008-07-31
2014-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Glucarpidase arm
In the NOPHO ALL-2008 protocol patients with delayed methotrexate elimination (DME) in high-dose methotrexate treatments should be given Glucarpidase (50 ie/kg) with-in 60 hours from start of the methotrexate treatment.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1 Year
18 Years
ALL
No
Sponsors
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Lund University Hospital
OTHER
Nordic Society for Pediatric Hematology and Oncology
OTHER
Responsible Party
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Jesper Heldrup
MD
Principal Investigators
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Jesper Heldrup, M D
Role: PRINCIPAL_INVESTIGATOR
University Childrens hospital, Lund, Sweden
Locations
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Department of Pediatrics, Rigshospitalet
Copenhagen, , Denmark
Helsinki University Hospital
Helsinki, , Finland
University of Reykjavik
Reykjavik, , Iceland
University Hospital of Trondheim
Trondheim, , Norway
Department of Pediatrics, Drottning Sylvias Pediatric Hospital
Gothenburg, , Sweden
Countries
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References
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Svahn T, Mellgren K, Harila-Saari A, Asberg A, Kanerva J, Jonsson O, Vaitkeviciene G, Stamm Mikkelssen T, Schmiegelow K, Heldrup J. Delayed elimination of high-dose methotrexate and use of carboxypeptidase G2 in pediatric patients during treatment for acute lymphoblastic leukemia. Pediatr Blood Cancer. 2017 Jul;64(7). doi: 10.1002/pbc.26395. Epub 2016 Dec 14.
Other Identifiers
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NOPHO2008CPG2
Identifier Type: -
Identifier Source: org_study_id
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