DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017