Glucarpidase (CPG2) Effect on Severe Delayed Methotrexate-clearance in Children Treated Wih High-dose Methotrexate in Acute Lymphoblastic Leukemia (ALL) (NOPHOCPG2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2011 by Nordic Society for Pediatric Hematology and Oncology
Sponsor:
Collaborator:
Lund University Hospital
Information provided by:
Nordic Society for Pediatric Hematology and Oncology
ClinicalTrials.gov Identifier:
NCT01305655
First received: February 28, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Acute Lymphocytic Leukemia
Drug: Glucarpidase
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Glucarpidase (CPG2) Effect on Severe Delayed Methotrexate-clearance in Children Treated With High-dose Methotrexate in Acute Lymphoblastic Leukemia (ALL)

Resource links provided by NLM:


Further study details as provided by Nordic Society for Pediatric Hematology and Oncology:

Primary Outcome Measures:
  • 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. [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate time at hospital and health costs [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: January 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Glucarpidase
    Patients treated with Glucarpidase 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 will be compared with patients in just below the tricking values.
    Other Name: VORAXAZE®
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

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01305655

Contacts
Contact: Jesper Heldrup, M.D. +46705172389 jesper.heldrup@skane.se
Contact: Arja Harila-Saari, M.D. Ph.D +358400684524 aria.harila-saari@oulu.fi

Locations
Denmark
Department of Pediatrics, Rigshospitalet Recruiting
Copenhagen, Denmark, DK-2100
Contact: Kjeld Schmiegelow, M.D.    +45 35451357    kschmieqelow@rh.regionh.dk   
Principal Investigator: Kjeld Schmiegelow, M.D.         
Finland
Helsinki University Hospital Recruiting
Helsinki, Finland
Contact: Kim Vettenranta, M.D.    + 35 850-3676528    kim.vettenranta@pshp.fi   
Principal Investigator: Kim Vettenranta, M.D.         
Iceland
University of Reykjavik Recruiting
Reykjavik, Iceland
Contact: Olafur Jonsson, M.D.    +354 5431000    olafurgi@landspitali.is   
Principal Investigator: Olafur Jonsson, M.D.         
Norway
University Hospital of Trondheim Recruiting
Trondheim, Norway
Contact: Ann Åsberg, M.D.    + 47 92626432    ann.asberg@ntnu.no   
Principal Investigator: Ann Åsberg, M.D.         
Sweden
Department of Pediatrics, Drottning Sylvias Pediatric Hospital Recruiting
Goteborg, Sweden
Contact: Jonas Abrahamson,, M.D.    +46 707695159    jonas.abrahamsson@vgregion.se   
Principal Investigator: Jonas Abrahamson, M.D.         
Sponsors and Collaborators
Nordic Society for Pediatric Hematology and Oncology
Lund University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Nordic Society for Pediatric Hematology and Oncology, Lund University Hospital
ClinicalTrials.gov Identifier: NCT01305655     History of Changes
Other Study ID Numbers: NOPHO2008CPG2
Study First Received: February 28, 2011
Last Updated: February 28, 2011
Health Authority: Denmark: Danish Medicines Agency
Denmark: The Danish National Committee on Biomedical Research Ethics
Finland: National Advisory Board on Health Care Ethics
Finland: Finnish Medicines Agency
Iceland: Icelandic Medicines Control Agency
Norway: Norwegian Medicines Agency

Keywords provided by Nordic Society for Pediatric Hematology and Oncology:
Drug: Glucarpidase

Additional relevant MeSH terms:
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014