Glucarpidase (CPG2) Effect on Severe Delayed Methotrexate-clearance in Children Treated Wih High-dose Methotrexate in Acute Lymphoblastic Leukemia (ALL)
Information source: Nordic Society for Pediatric Hematology and Oncology
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Lymphocytic Leukemia
Intervention: Glucarpidase (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Nordic Society for Pediatric Hematology and Oncology Overall contact: Jesper Heldrup, M.D., Phone: +46705172389, Email: jesper.heldrup@skane.se
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.
Clinical Details
Official title: Glucarpidase (CPG2) Effect on Severe Delayed Methotrexate-clearance in Children Treated With High-dose Methotrexate in Acute Lymphoblastic Leukemia (ALL)
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: Evaluate time at hospital and health costs
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 > 20 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.
Eligibility
Minimum age: 1 Year.
Maximum age: 18 Years.
Gender(s): Both.
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.
Locations and Contacts
Jesper Heldrup, M.D., Phone: +46705172389, Email: jesper.heldrup@skane.se
Department of Pediatrics, Rigshospitalet, Copenhagen DK-2100, Denmark; Recruiting Kjeld Schmiegelow, M.D., Phone: +45 35451357, Email: kschmieqelow@rh.regionh.dk Kjeld Schmiegelow, M.D., Principal Investigator
Helsinki University Hospital, Helsinki, Finland; Recruiting Kim Vettenranta, M.D., Phone: + 35 850-3676528, Email: kim.vettenranta@pshp.fi Kim Vettenranta, M.D., Principal Investigator
University of Reykjavik, Reykjavik, Iceland; Recruiting Olafur Jonsson, M.D., Phone: +354 5431000, Email: olafurgi@landspitali.is Olafur Jonsson, M.D., Principal Investigator
University Hospital of Trondheim, Trondheim, Norway; Recruiting Ann Åsberg, M.D., Phone: + 47 92626432, Email: ann.asberg@ntnu.no Ann Åsberg, M.D., Principal Investigator
Department of Pediatrics, Drottning Sylvias Pediatric Hospital, Goteborg, Sweden; Recruiting Jonas Abrahamson,, M.D., Phone: +46 707695159, Email: jonas.abrahamsson@vgregion.se Jonas Abrahamson, M.D., Principal Investigator
Additional Information
Homepage of NOPHO - most areas are closed
Starting date: January 2011
Last updated: February 28, 2011
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